System Release Notes: Breast Imaging Workstation

Three Palm Software – Document # 71

Confidential Release 1.9.0

System Release Notes:

Breast Imaging Workstation This document contains confidential and proprietary information and may not be copied or reproduced in whole or in part without the express written permission of Three Palm Software.

Revision Description Date Author

65.1 Updates for the 1.9.0 release 07/02/20 pbh

65.2 Updated build numbers 04/20/21 pbh

66.0 Approved 04/22/21 pbh

This document is stored at http://periappi/engineering/WorkstationOne/System Development/SystemReleaseNotes.docx. The current version of this document should be read at that location only.

This document is based on the R&D SysRN template (document #62, revision 4.0).

At a minimum, the following people have reviewed this version of this document:

Name Title

Patrick Heffernan CEO/CTO

Ann Liu QA Manager

Yang Zheng VP Engineering

https://threepalmsoft.sharepoint.com/:u:/s/QS/ER42-7GG4qJJkD_kCDCwPrQB-slDjnw1DLiLjoeu-fOZKA?e=KSTUWO

https://threepalmsoft.sharepoint.com/sites/QS/SOP/Software%20development/System%20development%20templates/SysRN.htm



Content

1. Introduction .............................................................................................................. 3

1.1. Purpose ........................................................................................................... 3

1.2. Scope .............................................................................................................. 3

1.3. Related Documents ......................................................................................... 3

1.4. Definitions ........................................................................................................ 4

1.5. Acronyms and Abbreviations ........................................................................... 4

2. Compatibility and Interface Requirements ................................................................ 5

2.1. Hardware ......................................................................................................... 5

2.2. Software .......................................................................................................... 7

2.3. External Configuration Requirements .............................................................. 8

3. Distribution ............................................................................................................... 9

3.1. Distribution Method .......................................................................................... 9

3.2. Distribution Media ............................................................................................ 9

3.3. Responsibility................................................................................................... 9

3.4. User Documentation Requirements ................................................................. 9

3.5. Unique Device Identifier ................................................................................. 10

4. Installation .............................................................................................................. 10

5. Operation Overview ............................................................................................... 11

5.1. Details of Expected Usage ............................................................................. 11

5.2. Limitation on Use ........................................................................................... 12

6. Residual Risks ....................................................................................................... 12

7. Expected Maintenance ........................................................................................... 13

8. Summary of New Features and Changes ............................................................... 14

8.1. Enhancements ............................................................................................... 14

8.2. Defect Fixes ................................................................................................... 15

8.3. Regulatory Implications .................................................................................. 17

9. Outstanding Issue Reports ..................................................................................... 18

10. Notes ..................................................................................................................... 21



1. Introduction

1.1. Purpose

This document accompanies release 1.9.0 of Three Palm Software’s (TPS) Breast Imaging Workstation product – WorkstationOne™. This medical device is a vendor-neutral mammography interpretation workstation, with support for other imaging modalities that are used for breast cancer screening and diagnosis.

The intended audiences for this release are:

• For Clinical Studies, Product Evaluation or Third Party Qualification, or

• Luminary (user validation) sites that will be used to gather feedback on the use of this product, and

• End-user sites (chiefly in radiology departments) where it will be used as part of the process of routine reading of mammograms.

1.2. Scope

These notes apply to release version 1.9.0 of the TPS Breast Imaging Workstation software, as packaged into the WorkstationOne product on the 17th April 2021.

This product delivers:

Name Identifier Version

WorkstationOne WS1 1.9.0

which is packed as the following installation packages:


TPS.WorkstationOne. 1.9.0.10417.x64.exe

TPS.WorkstationOne. 1.9.0.20417.x86.exe ws1.9.0

1.9.0.10417

1.9.0.20417

Information on the unique device identifier for this release can be found in section 3.5 below.

1.3. Related Documents

This release includes the following documents:


Release Notes 71 66.0

User Manual 56 49.0

Service Manual 25 49.0



Enterprise Integration Manual 190 22.0

DICOM Conformance Statement 70 11.0

HL7 Conformance Statement 213 2.0

User Training Presentation 24 4.0

Additional documents generated as part of the development process (requirements, design, test reports, etc) are not included in the release package.

1.4. Definitions

Term Meaning

.NET Framework

Microsoft toolkit that is required for running much of WorkstationOne. This can be down-loaded from the Microsoft web site, and as it is a run-time pre-requisite of WorkstationOne.

Run-time pre-requisite

Code (such as dlls) that the product depends on in order to run. Run-time pre-requisites (such as the .NET Framework) are automatically downloaded and installed when this install is run if they are not already present on the target machine.

1.5. Acronyms and Abbreviations

In addition to the standard abbreviations, the following abbreviations may be used in this document:

Term Meaning

PC “Personal computer” – here the term refers to an Intel-compatible desktop or tower computer running a Windows operating system.

RAM “Random Access Memory”

MB Mega-Byte (of storage space)

GB Giga-Byte (of storage space)

GHz Giga-Hertz

SSD Solid State Drive



2. Compatibility and Interface Requirements

2.1. Hardware

This product is designed to run on a Windows platform, i.e., those that run Microsoft Windows 10, Windows 8 (8.1), and Windows 7, and which use Intel-compatible hardware (including processors from Intel and AMD). Windows versions Vista and XP are now considered to be obsolete. The recommended computers include those based on the Intel Core or equivalent Xeon processor and later processors with a minimum of 8GB RAM (a minimum of 16GB is suggested for sites with tomosynthesis data), running an x64 version of the OS. The computer may need to have a power supply capable of driving the high-end medical imaging graphic card (e.g., depending on the graphic cards, this may mean an extra power connector and 2 or more PCIexpress x16 slots).

Disk speed is critical for loading performance. A typical configuration is a system with a SSD, or with two disks in a RAID-0 configuration (striping), e.g., two 750GB disks in a RAID-0 configuration. The disk space required to run this product depends on the size of the images produced by the FFDM devices in use at the site, and the compression that is supported by the PACS, and how long the site needs to keep the studies on the workstation. For example, 300GB or more is recommended for a site to retain for a month the studies collected at a daily rate of 25 patients when the studies are conventional 4-view mammograms. Sites collecting tomosynthesis studies will have higher storage requirements.

Typically systems are configured with a keyboard with arrow keys, and a mouse with a center wheel – preferably a programmable mouse. Programmable keypads can also be used. The key-codes which can be used for programming a mouse or keypad are included in the user manual.

WorkstationOne receives mammographic images and related information such as CAD report files from PACS or FFDM, and optionally a CAD server, through the network. WorkstationOne also sends the recall forms, screening reports and GSPS graphic annotations to PACS. The recommended network speed is 100Mbit or better.

In order to take advantage of hardware acceleration, the recommended graphic cards include NVIDIA Quadro cards, Barco MXRT cards and the AMD Radeon cards. Special attention should be paid to the compatibility of multiple card combinations when driving multiple displays (e.g., one color low-resolution monitor and 2 3MP or 2 5MP high-resolution gray-scale monitors). Detailed compatibility information can be obtained from the graphic card vendors, or by consulting with TPS support personnel. For NVIDIA cards, the validated combinations are Quadro 2000D + Quadro 600 (the equivalent now being a Quadro K2200); for Barco cards, the validated combinations are MXRT-7300 + MXRT-5200, but graphics card models change frequently, so check with TPS support for specific combinations.

The monitors used by the workstation typically include one color monitor and two 3MP or two 5MP (or one 10MP) high-resolution grayscale monitors. The high-resolution grayscale monitors must have FDA clearance for use in the US. The resolution of the color monitor is normally set to at least 1680x1050 and depth of 32 bit. The resolution of



the 5MP monitors should be 2048x2560 (or 2x2048x2560 for one 10MP monitor) and either 32bit or 8bit static gray. The resolution of 3MP monitors should be capable of 1536x6144 (i.e., 9M sub-pixels driven independently). The following flat panel displays have been tested to work with this or earlier releases:

Manufacturer Display Model Graphic Card

NDS/Dome Dome E5

Dome S10

NVIDIA FX4600 + FX370

NVIDIA Quadro 2000D + 600

Matrox Xenia Pro

Eizo

GS510

GS520

GX1030

RX840-MG



Matrox Xenia Pro

AMD Firepro V4800

WIDE PN211QS

RealVision SMD



Totoku / JVC Kenwood

ME551M

MS33i2

MS31i2



Matrox Xenia Pro

Barco

Coronis 5MP

Nio 5MP

Fusion 10MP

Barco MXRT 4600

Barco MXRT 7300

+ Barco MXRT 5200

NEC MD205MG Matrox Xenia Pro

Sony LMD-DM50

LMD-DM30 NVIDIA Quadro 2000D + 600

For the Dome and Eizo displays with an NVIDIA Quadro card, the software can display 10bit gray scale when the corresponding display path (Opengl + NVIDIA) is configured on the service UI.

For Barco displays with MXRT cards, in order to use the 10bit grey-scale capability, the displays should be set to 30bit in the driver control panel.

For Totoku/JVC Kenwood and Sony 3MP-based displays, even though the 3MP display monitors are configured as 1536x2048, WorkstationOne can be configured (using an option in the app-config service UI) to display at a resolution of 1536x6144 (i.e., 9M sub-pixels driven independently – called ISD). For best ISD performance, a CUDA capable card is recommended (see https://developer.nvidia.com/cuda-gpus).

The mammography recall reports, screening reports, structured reports and simple reports generated from WorkstationOne can be printed using a standard Windows printer. Thus there is no definitive list of printers that are supported.

https://developer.nvidia.com/cuda-gpus



WorkstationOne can be configured to act as a DICOM Print SCU, supporting Basic Grayscale Print Composition. The following DICOM film printers have been tested to work with this or earlier release:

Manufacturer Model Name and Number

Kodak (Carestream) Dryview Imager 8900

Konica Minolta DRYPRO 793

Agfa Healthcare DRYSTAR AXYS

Fuji Photo Film DryPix 4000, 5000, 7000

Sony UP-DF750

The supported film sizes include 8”x10” and 10”x12”, which are automatically selected based on the image’s “true size” (i.e., its real-world physical size).

In addition to the above hardware guidelines, detailed hardware selections can be aided by consultation with TPS personnel. PC hardware evolves rapidly, and so any deployment is likely to target better hardware than what is outlined above.

2.2. Software

WorkstationOne is designed to run on Microsoft Windows. It is recommended that a 64 bit version of the Windows Operating System is used as the host on the system running WorkstationOne. The following targets are supported by the installation package:

• Windows 7 (SP1 or later)

• Windows 8.1

• Windows 10

In all cases, all Microsoft recommended patches should be installed. Both 32 bit (x86) and 64 bit (x64) versions are supported, with native WorkstationOne installs available for each. However it is strongly recommended that customers using 32-bit versions of Windows upgrade to a 64-bit version, as 32-bit versions of WorkstationOne may not be available for future releases.

The installation package includes the TPS specific dependencies that are needed to run this software on the target platforms. The operating system dependencies generally do not need to be installed separately. However, the target computer is required to be connected to the internet during installation in order for the install to automatically download the required .NET framework and other run-time pre-requisites. Once WorkstationOne is installed, it can be started by clicking the desktop shortcut, or from the Windows Start menu (under “all programs” -> “Three Palm Software” -> “WorkstationOne”).

The user manual is provided in pdf format. This file can be viewed with any pdf viewer (such as Adobe Acrobat), but for ease of setup, the installation package includes a



simple viewer which can be used to display the manual (each site can configure which viewer to use).

No operating system setting changes are needed for x64 versions of Windows, however for x86 (32bit) versions of the OS, the system memory should be set to allow the application to take advantage of more than 2 GB on machines that have that much memory. Details on how to configure this on 32 bit versions of the OS (the mechanism is different on Vista and later operating systems, compared to XP) can be found in the service manual.

Note that the large memory setting is not currently tested with the Matrox MED5mp graphic card driver and the latest NIVIDA drivers (version 197.03 or later).

2.3. External Configuration Requirements

Setup of the target hardware and operating system is expected to be performed before this product is installed. This task includes the installation of the operating system, and appropriate device drivers and OS patches.

The workstation is typically networked with PACS and CAD servers in order to receive images and reports; and send recall forms, screening reports, structure report or GSPS graphic annotation. In the case where the system is configured to support a legacy FFDM push model, or PACS auto-routing model, the images likely are sent directly from a FFDM device or PACS. In order to setup connection in this way to push images to WorkstationOne, the following parameters from the WorkstationOne configuration need to be recorded after the installation, and supplied to the person configuring DICOM on the FFDM or PACS:

WorkstationOne settings Values

Host name or IP address

AE title of the “Store” adapter Default is “WS1”

Port used by the “Store” adapter Default is “104”

Accepted AE titles of the “Store” adapter Default is “*” (i.e., any)

Other configurations include

• Modality Worklist (MWL)

• Query/Retrieve PACS

• Sending GSPS graphic annotation or SC screen capture to PACS

• Sending Recall Form, Screening Report or Structured Report to PACS/RIS

• Email Recall Form or Screening Report

• Reporting System interface via files, or for clinical study

• Reporting System interface via TCP/IP

• Windows Print

• DICOM Print

• Multi-system worklist change synchronization



• File importation

• HTTP listener for opening a study

• HL7 listener or sender for worklist status synchronization

• Storage receptors, other than default (above).

3. Distribution

3.1. Distribution Method

WorkstationOne is installed using an automated install package. The install is invoked by simply executing the “exe” package, which checks and installs any missing pre-requisites, and then the WorkstationOne install itself (the contained “msi”) is automatically started.

The installation package is made available on the internal server share \\periappi\installs\WorkstationOne\. The installation package names specifically related to this release are “1.9.0\TPS.WorkstationOne.1.9.0.10417.x64.exe”, and “1.9.0\ TPS.WorkstationOne.1.9.0.20417.x86.exe”. The install package is made available to partners on the TPS ftp site in the virtual folder “WorkstationOne”.

Installers should down-load the corresponding OS package to the target platform, and then execute the downloaded “exe” file. This then prompts the user with a series of installation screens, with default responses designed to meet the requirements of most users. The same package includes an un-install option.

3.2. Distribution Media

Only electronic (down-load) distribution is supported, so there is no physical media produced for this release.

3.3. Responsibility

Distribution of the software product to end users is the responsibility of the Service and Support organizations of TPS’s distributors and OEM partners, except in the case of luminary sites, which TPS supports directly.

Management of customer systems, including security provisions, is the responsibility of the agent responsible for site IT. This includes security aspects: policies; procedures; user training on those procedures; and hardware and software mechanisms for ensuring the security of the site.

Configuration and issuing of a license for the software is the responsibility of the installer.

Training is the responsibility of TPS or the appropriate partner’s application group.

3.4. User Documentation Requirements

This product has 510(k) clearance (K073272) from FDA. The labeling can be found in the user manual and the 510(k) summary.



The user manual is available from within WorkstationOne (third button at the top left), and on the Windows Start menu (under “all programs” -> “Three Palm Software” -> “WorkstationOne”). A printed copy of the user manual is also available on request (to [email protected]). The user manual is available on the customer portal: https://threepalmsoft.com/workstationone-customer-portal/ (contact Three Palm Software to obtain a password).

3.5. Unique Device Identifier

This product includes a Unique Device Identifier (UDI) that complies with FDA and EU requirements. The UDI is comprised of a Device Identifier (DI) and a Production Identifier (PI). The DI is unique to each release, and is recorded in the FDA GUDID database (see AccessGUDID). The DI may also be registered in European UDI databases by importers. The DI for this release is:

B148WSONE1900

Which follows the HIBCC encoding, with B148 being the Labeler Identification Code (LIC) for Three Palm Software, WSONE190 is the product number (specific to the 1.9.0 release), and the unit of measure is 0.

The PI is specific to each install, and encodes the version number (repeated, but as the full 4 field version, which includes the build number) and the device serial number. The DI and PI are displayed directly on the “About box” (in the format “text under primary bar code” - i.e., with additional formatting characters at the beginning and end), and the UI provides buttons to copy the DI and also the UDI (concatenated DI + PI format) to the clipboard, so they can conveniently be used externally.

4. Installation

This product is installed using an automated install package. Details on how to perform that process are described in the service manual, and are not duplicated here. However the following additional notes should be considered for sites upgrading:

• The 1.7.2 release introduced a change to the way that system settings are stored. For an upgrade of an existing 1.7.1 or earlier install to 1.7.2 or later, the settings are automatically migrated to the new storage the first time “APP config” is run. Thus it is recommended that “APP config” be started immediately after an upgrade from 1.7.1 or earlier install (even if no changes to settings are needed), as this will ensure that any pre-existing application-level settings are carried over to the new storage mechanism.

• The 1.7.2 and later releases include a number of mechanisms to improve performance – particularly for tomosynthesis studies. These mechanisms take advantage of the CPU, memory and disk – so these optimizations may not be appropriate for all machines. In particular:

o A 32 bit machine should have the frame cache disabled (it is unlikely that a site with a 32 bit OS would be reading tomosynthesis studies, but it is possible).

https://accessgudid.nlm.nih.gov/



o In cases where the CPU load is too high (slower machines, or machines with insufficient CPU cores) the number of threads should be reduced. The default is 4/4/4 threads (see service manual, or “APP config” loading tab), but this can be reduced to 1/1/1 (which then is the same as 1.7.1 and earlier releases).

o A detailed discussion of performance tuning can be found in the “Performance notes” appendix to the service manual.

• The 1.8.0 release introduced a new reporting mechanism – via the Reporting plugin. The existing reporting mechanisms (recall and screening forms, simple report generator, etc) are still supported in 1.9.0. However, it is suggested that sites migrate to the new mechanisms which are more powerful and flexible. By default (at initial install or upgrade), the Reporting plugin (and there can be multiple) is not configured. For sites requiring the built-in reporting, this should be configured from app-config (plugins tab) prior to use of the new version. The service manual has additional details on such configuration.

• The internal database engine was updated at release 1.8.6. This means that backwards downgrade to an earlier version (from 1.8.6 or later) is not as simple as the automated upgrade mechanism. If such a downgrade is necessary, TPS support should be consulted for detailed advice on the procedure.

5. Operation Overview

5.1. Details of Expected Usage

The workstation software is essentially an executable, several configuration files, and a set of dlls. The product is usually used within the environment of a breast center.

A typical workflow in a mammography facility is shown in the following figure: a patient is scheduled for a mammography screening or diagnosis exam, the imaging procedure is performed by an acquisition modality, then the images are interpreted by the radiologist and a report is generated.

In digital mammography, WorkstationOne can be used by the radiologist to make an interpretation. The interpretation task always requires viewing of the priors when



available in order to make comparison with the current mammograms. When a patient is scheduled for an exam, the prior mammogram images will be pre-fetched from an archive, or digitized from films. After the current exam is performed, its images are typically sent to an archive, such as a PACS. Sometimes, in a legacy setting, the images may directly be pushed to the workstation from the acquisition modality. Otherwise the workstation queries and retrieves the current exam’s images for the radiologist to review, and the radiologist generates a report or a dictation.

In practice this essentially means that the workstation is executed repeatedly in a closely monitored and repeatable fashion:

• Use “>” icon (available on both color display and high-resolution display) to open a patient exam;

• Continue to use the “>” icon to step through the following viewing steps:

o Overview of all 4 images from the current study and all 4 images from a prior study;

o Large view of current study, and QC, if configured o Current and prior study comparison o Systematic viewing o Full resolution all pixels viewing o CAD report viewing and generation of a recall form for a screening study

• Continue to use “>” icon to open the next patient exam, and repeat the above steps

5.2. Limitation on Use

The workstation software should be used on FDA cleared high-resolution monitors in the US. The workstation software should also be used with FDA approved CAD devices in the US.

6. Residual Risks

A hazard analysis has identified the following risks that are associated with this product. These risks are mitigated by design controls. The risks and their controls are:

Hazard Cause Implemented control

H1. Patient is given over-diagnosis (i.e., unnecessary follow-up)

C1. System displays wrong (positive) images for this patient.

System testing considers this case to verify that the patient ID and associated images are from the same DICOM files displayed together correctly. H2. Patient is given

under-diagnosis (i.e., does not receive appropriate follow-up)

C2. System displays wrong (negative) images for this patient.

C3. System mistakenly replaces current exam images with prior negative exam images.

System is designed to prevent the user from adding markup (for diagnosis) on prior images.



C8. System does not automatically save the radiologist’s markup for patient recall when the radiologist opens another patient without completing the current patient.

System is designed so that when the user switches to another patient a popup dialog is used to warn the user the current case is not complete.

System is designed to alert the user to save any markup when switching to another patient without explicitly closing the current patient.

C9. User does not use the tools (full-resolution) provided by the system, may miss calcification.

System is designed to enforce the user to follow a workflow, with full-resolution viewing included as one step of the workflow.

C10. User does not use workflow tool, may miss to read all images, so may miss to see tumors.

H5. Delay report may cause patient anxiety.

C11. System used in an environment where distraction can cause user error, may miss to finish the study, so no report.

System is designed so that when the user switches to another patient a popup dialog is used to warn the user the current case is not complete.

C14. Computer components or network links fail intermittently.

Installer/support will warn site to monitor hardware, and replaced as needed.

H3. Operator gets eye strain

C4. Room ambient light too bright.

When an optimal viewing condition cannot be met, the system is designed so the user can change the font size larger and make the contrast of the images sharper in order to the improve viewing condition.

C5. Monitor position too high.

H4. Operator gets finger tiredness

C6. System requires too many mouse clicks.

System is designed to minimize the mouse clicks and mouse movement.

C7. System requires large distance mouse moving.

H6. Patient information exposed to unauthorized persons.

C12. Operating system defect allows unauthorized access.

Installer/support will warn customer to keep system patches current.

C13. Site procedures do not control access to the software.

Installer/support will suggest to site IT that they implement appropriate physical and procedural security mechanisms.

7. Expected Maintenance

This product displays and logs serious problems if they are encountered. The “application” category of the system event log is used on Windows. Detailed diagnostic information is available using a configurable “trace” mechanism, which can be used to collect detailed information in text files. When problems occur, these diagnostic mechanisms will be consulted for clues and pieces of those logs can be sent to the TPS engineering group for further analysis.



8. Summary of New Features and Changes

The following subsections list changes to this product relative to the 1.8.9 release. The full list of enhancements and fixes are detailed in sections 8.1 and 8.2.

8.1. Enhancements

The following enhancements are included in this release:

Group Description

CAD/AI integration

• Support for Hologic Genius AI CAD (score extraction on worklist).

• Hologic CAD (Genius 3D and 2D) logos have been updated.

• updates for the latest SR specs from Hologic.

• Expanded "details" display for iCAD reports with distance measurements from chestwall/nipple, and marker long axis.

• DeepLook 2.0 interactive CAD support has been added.

• Added support for loading hidden CAD reports at case open, so any breast density information from them can populate at the start (e.g., buttons).

Viewing

• new HP have been added.

• more detailed sort options for contrast and CESM images have been added (to enable better grouping of those types).

• SR viewer plugin - added support for displaying icons from "key images" section of a received SR, if included.

UI changes

• UI improvements to handle screens with >100% scaling.

• Click on patient-name on main screen now causes the worklist to scroll to the open patient (when there is a worklist displayed).

• Query dialog - "approximate" checkbox state is saved between uses.

• QR browser now has a "clear" button to remove the 3 matching strings (in addition to the separate "x" button for each).

• QR browser grid font has been updated to match the worklist font size.

• Added a user option (not on UI) QueryFollowsOpenedCase that causes the QR browser to follow the opened case when it remains displayed across open of a new case (default is ‘true’).

• A new version of the import tool has been added. This is the default for new installs and can be configured on app-config for upgrades (image loading tab).

Usability

• Worklist Companion tool has been added. This supports management of the worklist from a different location.

• Plugins (such as “Compare”) now have the capability to request display of the QR dialog for a specified patient.



• On the image screens the thumbnail menu now has the action to raise the QR dialog for that case.

Performance

• IPP 2020 update 2

• DevExpress 20.2.6

• Visual Studio 2019 (16.9.3) & toolset 142

• Visual C++ 14.28.29914

Interoperability

• Expanded support for SCT codes - arriving data can use either SCT or legacy SRT codes without configuration.

• An option has been added to utilize SCT (rather than SRT) codes when exporting a SR using the BIR template from the recall form.

• AdapterVIHA added.

• The reporting plugin has a new option to include thumbnails as "key images" when generating a basic-text SR.

Service

• A new configuration option has been added for custom CAD score formatting for Hologic CAD reports.

• CAD score extraction for a specific vendor is disabled when the configured format string is empty for that vendor. This is useful when a study may have “CAD” reports from 2 or more vendors.

• The default service start mode has been changed to "delayed auto start" to help on slower machines (avoids a Windows bug where a service may not be started after a reboot in some circumstances).

• The back-end Windows service has been changed to use “Applications and Services Logs” -> “TPS WorkstationOne”, rather than the legacy “Windows Logs” -> “Application” for items logged to the event log. This change takes effect on the next start of the backend after the service tool “BEconfig” is run.

• The option PreferSCT has been added as an application setting (app-config -> export option for recall report) to support SCT usage in SR generation (as described above).

8.2. Defect Fixes

The following problems are resolved in this release:

ID Title Severity Description

In previous releases, if DICOM C-GET was used, the temporary files would go to the C:/temp folder.

5 AdapterQR dedicated cache folder for received "get" objects – under the data folder -> temp -> QR adapter name.



In previous releases, remote requests (e.g., from an external worklist) were checked for duplicate (repeat) view requests.

5 This logic now handles duplicate requests to open a case without any MG studies – to avoid rapid re-opens of the case.

The existing code handled bitmap (such as group 6000) overlay re-orientation (e.g., rotate), but if the bitmap was smaller than the image (with an offset), the offset was not used in computing the rotated position.

5 Any offset of a bitmap in group 6000 overlay is used in the calculation of the rotated position now.

In the 1.8.9, when markup was entered on a prior, it was correlated with any with the same name on current views. Since the acquisition geometry is different, this should not be done.

5 In 1.9.0 we have restricted the markup-correlator to display only for markup drawn on the current study.

Issue #186

In previous releases, if there were multiple slave clients, and more than one asks for the same file, then it may only go to one client in that cycle.

5 The logic for handling export requests has been updated to explicitly allow for the same file going to multiple destinations.



Where each problem is listed with an associated “severity” – a severity of “1” is considered a serious problem, and “4” is the least severe. Enhancement requests are assigned a severity of 5.

8.3. Regulatory Implications

This device has an existing FDA 510(k) clearance (see K073272). The changes in this release of this existing device do not change labeling, technology or performance specifications (see the flowchart quoted from FDA document “Deciding When to Submit a 510(k) for a Change to an Existing Device”). The fixes of the issues (see section 8.2) or enhancements added (see section 8.1) are minor and will not significantly affect the safety or effectiveness of the device. Therefore, the decision based on comparison between the version 1.0.0 described by the cleared 510(k) and this version is to include the changes summarized in the previous sections without submitting a 510(k).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K073272

http://www.fda.gov/cdrh/ode/510kmod.pdf

http://www.fda.gov/cdrh/ode/510kmod.pdf



9. Outstanding Issue Reports

The following known issues (defects and enhancements) are not yet resolved, and are deferred to a follow-on release:

ID Title Severity Description

62

Opengl/tomo icon slow to display, and resource exhaustion on AMD cards

5

AMD (ATI) graphics cards with recent drivers exhibit a delay when opening a tomo view with the 3D icon. Eventually (several tomo views open, or after many cases) the system generates an error due to the low-level driver resource exhaustion. This problem is not seen with NVIDIA graphics cards. The suggestion is that sites reading tomo studies with AMD graphics cards should run with “allow tomo icon” turned off (or switch to an NVIDIA card).

Issue #134

Mouse wheel action – center zoom 2D / scroll for tomo

5

The configuration allows the mouse wheel action to be one of the actions (center zoom, extra views, etc), but it has been suggested that a combined mode would be good. So the mouse could be configured for center zoom (for example), and still have it do scroll when in a tomo view.

Issue #143

auto-collapse of icons

5

Sites with large number of images in the current study (or even priors) would like a way to more rapidly navigate or organize their icons. Currently manual scrolling and resize of the icon region is supported, but an idea is to automatically collapse (with a config option) sets of images in the same study. For example, all c-view images, or all DBT images, so that that group would be represented as a single icon, which would expand either on mouse-over, or on click (perhaps popup tooltip like) to show the enclosed icons, which can then be dragged like now).

Issue #147

Cine of multiple viewports

5

A couple of suggested enhancements for (tomo) automated cine are:

1) allow “cine all” to continue across layout changes, which would be good for demos.



2) allow multiple viewport cine when one of the viewports is hidden with a “double-click” viewport. Currently synchronized cine doesn’t consider any double-click viewport.

Issue #151

Improve manual application of Tabar masks

5

When the user manually uses the masking tool at an arbitrary layout, the selected mask may not be optimal (e.g., layout with mlo and cc should show horizontal masks rather than oblique masks).

Issue #154

Prior markup warning not displayed in some situations

5

When configured, a popup warning dialog is shown when the user attempts to markup a prior image. However, in some situations the warning does not appear (although the user is blocked from drawing). Why the dialog is not shown needs to be investigated.

Issue #156

investigate short-cut key “ctrl” anomalies

5

For some key combinations, the (configured) use of the control key does not work the same as the key alone. This needs further investigation.

Issue #158

Reporting – link open step and read-only on UI

5

In the Reporting plugin, when the workflow auto-open is selected as “never”, and “unread case – view-only …” is checked, the reporting feature is basically disabled. It would be nice if the checkbox is auto-unchecked and automatically disabled when “never” is selected.

Issue #159

Worklist CAD filter and CAD-SR deletion

4

When the worklist “exclude if no CAD” is in use, and the open case has CAD, then deleting the CAD (e.g., manually from the worklist) results in the unexpected close of the case.

Issue #160

plugin simple viewers – check tool scope handling

5

In the simple viewers (US, MR, etc) the scope (image/series/study) is not the same for all tools (e.g., zoom, pan, or window-level). The scope needs to be more consistent.

Issue #163

pdf background color

5

When use a template with a color background (e.g., mammo patient letter template), the reporting plugin can generate an encapsulated pdf DICOM output, but the color



background disappears when the pdf viewer opens the result file.

Issue #168

JPEG2000Lossless color image generation

5

The 1.8.2 release supports sending of generated images in compressed formats. However, the low-level toolkit currently does not support the generation of jpeg2000 lossless for color images. Thus, for this release the system transparently disables jpeg-2000 lossless (if configured) for negotiation of sends of color images.

During internal testing for 1.8.9 it was noticed that save of a file as jpeg-2k lossless is also incorrect for grey-scale images. The transfer to jpeg-2k when sending to another DICOM destination is correct – this only seems to apply to a local file save. There is no error reported, but the image contents are apparently empty. This can only occur with the file exporter and this option (compress to jpeg-2k) set.

Issue #170

Localization for SR 5 Investigation needed to see how auto-generated SR should handle localization.

Issue #171

Arrow up/down keys access to missing prior

5 Even with “avoid blank on more priors” with the arrow keys a viewport can be blank if the first or last prior is missing for that view.

Issue #174

GSPS measurement text – superscript in Japanese Character Set

5

The current default character set for generated Japanese text does not include the superscript character, so a measurement with a superscript (e.g., “mm2”) appears with non-superscript characters.

Issue #175

Implant not consistent in new fanning HP with interleave off

5

When the configuration option “interleave implant views” is unchecked, 1x4 CC and 1x4 MLO (fanning HP) display correctly for ID views, but not for implant views.

Issue #179

CAD assessment dialog – limitation

5 CAD assessment dialog is resizable – but if it is made too small, the tick can be hidden.

Issue #180

Worklist2 DG_DataError logged

5 In some scenarios, the trace has the message: “WorklistDisplay2.DG_DataError: Formatting, PreferredSize”. There is no user-



visible effect, and it is not clear how to reproduce this. The release includes logging that can help narrow this down if it occurs in the field.

Issue #181

Add alternate tomo icon renditions

5

It has been suggested to add the ability to switch the tomo 3D icon to other forms (e.g., a fixed wire-frame rather than the cut-plane and skin surface which is currently supplied).

Issue #182

Report plugin blank print layout view

5

It has been seen that the reporting plugin appears blank in some scenarios – but is fine when switch to “print layout” mode. This may be related to specific graphic cards but is currently not reproducible. It may be addressed by updates to the underlying toolkit (DevExpress renders the report editor).

Issue #185

Image display using DD and acceleration does not handle 12-bit signed images

5

Signed 12-bit pixels is a rare format (not used in mammography), and such images are handled (displayed) correctly with both GDI and DD (unaccelerated) paths. However, DD-accelerated (direct3D) does not display such images correctly.

where each problem is listed with an associated “severity” – a severity of “1” is considered a serious problem, and “4” is the least severe. Enhancement requests are assigned a severity of 5.

10. Notes

None.

System Release Notes: Breast Imaging Workstation

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