SenoIris is designed for diagnostic review in diagnostic and screening breast imaging environments through flexible and interactive manipulation of multi-modality, multi-vendor softcopy images.

It provides image review, manipulation, analysis, Post-Processing and printing capabilities for FFDM, DBT, and CESM images. The software also supports the display of CAD, breast density assessments and other breast imaging data from various modalities.

Image routing and compression, as well as centralized workflow steering. including double blind reading and integrated in-image reporting, are part of the solution to support the women's healthcare professionals to enrich existing workflows for breast imaging needs.

Various specific and general interfaces exist to synchronize to other external software on the front- and back-end side. The software also provides functions to directly import data from and export them to mobile storage media or onto the local operating system.

Device Description

The SenoIris is a medical image review workstation software for diagnostic and screening mammography.

SenoIris has the capability to review Digital Breast Tomosynthesis (DBT) images that are compatible with Breast Tomosynthesis Image Storage.

It is a software product.

AI/ML Overview

The provided text describes information about the SenoIris device, a medical imaging software. Here's a breakdown of the requested information based on the text:

1. A table of acceptance criteria and the reported device performance

The document states: "A clinical reader study has been performed and has shown that the image quality of V-Preview of SenoIris is either better or equivalent to the image quality of V-Preview of the predicate device MammoWorkstation."

Acceptance Criteria (Implied)	Reported Device Performance
Image quality of V-Preview is better than or equivalent to the predicate device.	The image quality of V-Preview of SenoIris is either better or equivalent to the image quality of V-Preview of the predicate device MammoWorkstation.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size for the test set or the data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number of experts or their qualifications. It only refers to a "clinical reader study."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe the adjudication method used for the test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document mentions "A clinical reader study has been performed" for image quality comparison, but it does not specify if it was an MRMC comparative effectiveness study, nor does it provide information on an effect size of human readers improving with AI vs. without AI assistance. The device is primarily a review workstation software, not an AI-assisted diagnostic tool in the typical sense of providing a computer-aided detection/diagnosis score.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a "medical image review workstation software," implying human-in-the-loop performance. The document does not describe a standalone algorithm-only performance study. The statement "V-Preview is an additional image for navigation use only and does not replace FFDM image" further reinforces its role as an aid for human review rather than a standalone diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document relates the study to "image quality," which suggests a subjective assessment by readers. It does not explicitly state the type of ground truth used for establishing the image quality, but it implies comparison against a predicate device based on expert perception.

8. The sample size for the training set

The document does not mention the sample size for any training set. The descriptions of "image quality improvement" through "modified generation algorithm" and "lowering the artefacts and the noise" suggest algorithmic improvements, which would typically involve training data, but the details are not provided.

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for a training set was established.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 1, 2016

GE Healthcare (Image Diagnost International) % Mr. Mounir Zaouali Regulatory Affairs Leader Oskar-Schlemmer-Str. 11 Munich D-80807 GERMANY

Re: K160937

Trade/Device Name: SenoIris Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 23, 2016 Received: June 27, 2016

Dear Mr. Zaouali:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oaks

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160937

Device Name SenoIris

Indications for Use (Describe)

Senolris is designed for diagnostic review in diagnostic and screening breast imaging environments through flexible and interactive manipulation of multi-modality, multi-vendor softcopy images.

Contraindications

Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless cleared for use in digital mammography.

Review monitors used for primary diagnostic interpretation of mammographic images must be cleared for use in digital mammography.

All images sent to or imported in the SenoIris must fulfill the regulatory requirements. Image quality must conform with applicable quality guidelines.

For Diagnose Mode, all modalities must be certified for soft-copy reading

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo, which is a circular emblem with the letters 'GE' in a stylized, cursive font at the center. The logo is colored in a light blue hue. The 'GE' letters are surrounded by a circular border that is adorned with wave-like or flame-like designs, also in the same light blue color.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	April 1, 2016
Submitter:	GE Healthcare (Image Diagnost International)Oskar-Schlemmer-Str. 11;80807 München, Germany
Primary Contact Person:	Mounir Zaouali,Regulatory Affairs LeaderGE Healthcare,283 RUE DE LA MINIERE78530 BUC – FRANCEPhone : + 33 1 30 70 45 39Fax : + 33 1 30 70 41 40Email : Mounir.Zaouali@ge.com
Secondary Contact Person:	Diane UriellDirector of Regulatory Affairs, XR and Women's HealthGE Healthcare,AtlantaPhone +1 262 290 8212Email:Diane.Uriell@ge.com .
Device Trade Name:	SenoIris
Common/Usual Name:	Medical imaging software
Classification Names:	Picture archiving and communication systemClass II CFR 892.2050 System, Image Processing, Radiological,
Product Code:	LLZ
Predicate Device(s):	MammoWorkstation (K143361)
Device Description:	The SenoIris is a medical image review workstation softwarefor diagnostic and screening mammography.SenoIris has the capability to review Digital Breast Tomosynthesis(DBT) images that are compatible with Breast TomosynthesisImage Storage.It is a software product

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular shape. The circle has decorative, swirling elements around its perimeter, giving it a distinctive and recognizable appearance.

GE Healthcare

GE Healthcare
	510(k) Premarket Notification Submission
Intended Use:	SenoIris is designed for diagnostic and non- diagnostic reviewin diagnostic and screening breast imaging environmentsthrough flexible and interactive manipulation of multi-modality,multi-vendor softcopy images.
	It provides image review, manipulation, analysis, Post-Processing and printing capabilities for FFDM, DBT, andCESM images. The software also supports the display of CAD,breast density assessments and other breast imaging data fromvarious modalities.
	Image routing and compression, as well as centralized workflowsteering, including double blind reading and integrated in-imagereporting, are part of the solution to support the women'shealthcare professionals to enrich existing workflows for breastimaging needs.
	Various specific and general interfaces exist to synchronize toother external software on the front- and back-end side. Thesoftware also provides functions to directly import data fromand export them to mobile storage media or onto the localoperating system.
	ContraindicationsLossy compressed mammographic images must not be used forprimary diagnostic interpretation unless cleared for use indigital mammography.
	Review monitors used for primary diagnostic interpretation ofmammographic images must be cleared for use in digitalmammography.
	All images sent to or imported in the SenoIris must fulfill theregulatory requirements. Image quality must conform withapplicable quality guidelines.For Diagnose Mode, all modalities must be certified for soft-copy reading
Technology:	SenoIris is a software product. It is designed to run on astandard workstation with a minimum of three monitors, onecontrol monitor and high-resolution monitor (s) that are clearedfor mammography review.
	It runs on Windows Operating System.
Comparison Of	The following is an overview of the differences between the
Technological	proposed SenoIris and the predicate MammoWorkstation. Refer
510(k) Premarket Notification Submission
Characteristics With ThePredicate Device:	to the Comparison Matrix in Section 12.1 for additionalinformation regarding the changes.
	SenoIris ConfigurationsAs with the predicate device, SenoIris has 3 configurations ormodes, The primary difference between the predicate device isthat the naming convention and combining of modes into onemode to yield the Connect Mode.
	1. The Diagnose Mode is designed to assist radiologists inconducting primary diagnostic interpretation for diagnosticand screening mammography through flexible andinteractive manipulation of multimodality softcopy images.This mode has the same functionalities as the currentlymarketed MammoWorkstation
	2. The Review Mode has been designed as thetechnologist's workplace for the management of clinicaldata and image display. The Review Mode provides easyaccess to prior images and reports. This mode has the samefunctionalities as the currently marketedMammoDocumentationStation.
	3. The Connect Mode enables the SenoIris to send DICOMdocuments to external systems by telemammography.Furthermore it provides Central User Management, whichallows organizing complex, multi-site processes like user-related worklists and automated double reading, particularlyfor screening. This mode combines the functionalities of thecurrently marketed Collaboration Server and DicomShuttle.
	DBT Review – 2D Synthesized ImageSenoIris was designed to provide several additional tools for thereview of DBT images and mainly to the synthetized 2D imagethat is called “V-Preview”. Modifications include image qualityimprovement, V-Preview Navigate and V-Preview Inspect.
	During GE DBT acquisition, 9 projections are performed byangulating the X-rays tube around the central projection (when themain X-ray beam is perpendicular to the detector). The V-Previewimage is reconstructed from this central projection byincorporating other information from the other projections.
	V-Preview is an additional image for navigation use only and doesnot replace FFDM image.
GE Healthcare
510(k) Premarket Notification Submission
Image Quality ImprovementSenoIris improves the image quality of V-Preview image by theimplementation of a modified generation algorithm by loweringthe artefacts and the noise of the image.
V-Preview Navigate (with V-Preview Inspect V-PreviewBookmark)SenoIris adds V-Preview Navigate that uses a cross referencemechanism between every point of the V-Preview image to theassociated DBT planes or slabs and position within those planes orslabs. So when the user indicates a location in a V-Preview imagein one display monitor by clicking on it, the DBT plane or slabcontaining this structure will be directly displayed in the othersecond display monitor.
When combined with V-Preview Inspect, the correspondingportion of slab or plane will be displayed in a pop-up smallwindow on the V-Preview image itself. Also, when the V-PreviewBookmark feature is enabled, for every annotations made on anyDBT slab or plane a navigation pointer will show on thecorresponding area of the V-Preview image.
Cybersecurity:The security of SenoIris is also improved from the predicate to bealigned to the recent FDA cybersecurity requirements enforcementthrough several guidance's (e.g. FDA Guidance, Content ofPremarket Submissions for Management of Cybersecurity inMedical Devices, October 2, 2014).
Usability:Other modifications are related to the improvement of the usabilityof the software with a redesigned user interface with a simplerlook. Certain functions and preferences are bound to the user log-in. The software stores and remembers several settings from thelast session of the user, for example the hanging protocols andtools bar position,SenoIris provides several images printing improvement including.
the option for configuring multiple DICOM printers and severalprinting preferences.
Accessories
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:The SenoIris and its applications comply with voluntarystandards as detailed in Section 9, 11 and 17 of this premarketsubmission. The following quality assurance measures wereapplied to the development of the system:• Risk Analysis• Requirements Reviews• Design Reviews• Testing on unit level (Module verification)• Integration testing (System verification)• Performance testing (Verification)• Safety testing (Verification)Summary of Clinical Tests:A clinical reader study has been performed and has shown thatthe image quality of V-Preview of SenoIris is either better orequivalent to the image quality of V-Preview of the predicatedevice MammoWorkstation.
Conclusion:	GE Healthcare considers the SenoIris to be as safe, aseffective, and performance is substantially equivalent to thepredicate device.
	Dedicated keypads are accessories to the SenoIris. The keypadsoperate like standard keyboard and mouse and emit shortcutssimilar to that of the standard keyboard or mouse wheel. There isalso some flexibility of the configuration of the buttons of thekeypads that can be done by the end user and described within theoperator manual.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The letters and the circle's outline are in a lighter shade of blue, creating a contrast with the darker blue background of the circle.

GE Healthcare

fication Submission

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle has a white border with decorative swirls, giving it a classic and recognizable appearance.

GE Healthcare

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" intertwined in the center. The letters are stylized and have a flowing, cursive appearance. The blue color is a vibrant and eye-catching shade.

GE Healthcare 510(k) Premarket Notification Submission

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).