Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.

The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

Device Description

The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis. but it does not directly generate any diagnosis or potential findings.

The following visualization, quantification and data-reporting functionalities are provided by the software:

Visualization:

2D image review -
3D image review by means of MIP, MinIP, Surface or Average -
Multi-planar reconstruction (MPR) views (axial, coronal, sagittal, and oblique) -
Image navigation tools -
Cine play -

Quantification:

Distance and area measurements -
Data reporting:
The distance, area, and user-selected annotated images are displayed to the user within the software client web browser. The user has the option to save the data for later use. The user can also send the data to PACS, for review.

AI/ML Overview

This document describes the Arterys Viewer, a medical imaging software. However, the provided text does not contain acceptance criteria, a study proving the device meets those criteria, or specific performance data related to accuracy or clinical effectiveness.

The document focuses on:

General Information: Manufacturer, contact, date prepared.
Device Description: Intended use (DICOM and non-DICOM data management, display, processing, storage, transfer), functionalities (visualization, quantification, data reporting).
Indications for Use: What the device is intended for and who uses it (trained medical professionals).
Comparison to Predicate and Reference Devices: A detailed table comparing feature sets, highlighting similarities and minor differences, and concluding substantial equivalence to a predicate PACS system and a previous version of their own software. This comparison is primarily about feature parity and technological characteristics, not clinical performance.
Performance Data (General Statement): A general statement that safety and performance have been evaluated and verified according to software specifications, applicable performance standards, and relevant FDA/IEC guidance documents.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document asserts that the device is substantially equivalent to a predicate, meaning it performs similarly and raises no new questions of safety or effectiveness, but it does not present a specific study with acceptance criteria and a detailed demonstration of the device meeting those criteria.

Here's a summary of what can be extracted from the provided text regarding performance context:

Device Name: Arterys Viewer
Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Product Code: LLZ
Regulatory Class: II

Regarding the specific questions:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for clinical use. The "acceptance" is implied through substantial equivalence to a predicate device, meaning it performs its intended functions similarly and safely.
- Reported Device Performance: No specific numerical performance data (e.g., accuracy, sensitivity, specificity, or measurement agreement) is provided. The performance is described in terms of its functionalities (display, processing, storage, measurements) and claimed to be verified through software V&V.
Sample size used for the test set and the data provenance: Not provided. The document mentions "software verification and validation testing" but does not detail the size or nature of the test data (e.g., retrospective/prospective, country of origin).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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: Not provided. The device is a "Viewer" and "does not directly generate any diagnosis or potential findings," implying it's a tool for professionals rather than an AI-assisted diagnostic algorithm in the sense of directly improving reader performance on a diagnostic task specified here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not provided. The device is intended to be used by "trained medical professionals" who interpret the information, so a purely standalone performance claim would be contrary to its stated use.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided.
The sample size for the training set: Not applicable based on the available information. The device is described as a "Viewer" with visualization and measurement tools, rather than a machine learning model that requires a distinct "training set" in the common understanding of AI/ML devices.
How the ground truth for the training set was established: Not applicable, as no training set is described.

In conclusion, the document primarily makes a case for substantial equivalence based on functional and technological characteristics compared to predicate devices, supported by general software verification and validation activities, rather than presenting a detailed clinical performance study with acceptance criteria.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

July 18, 2017

Arterys, Inc. % Ms. Golnaz Moeini Director of Quality and Regulatory Affairs 51 Federal Street, Suite 305 SAN FRANCISCO CA 94107

Re: K171544

Trade/Device Name: Arterys Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 24, 2017 Received: May 26, 2017

Dear Ms. Moeini:

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

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/ResourcesforYou/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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K171544

Device Name Arterys Viewer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over The Counter Use (21

| X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines running parallel to each other. The lines appear to be of equal thickness and are black.

Section 5. 510(k) Summary

1. General Information

510(k) Sponsor	Arterys Inc.
Address	51 Federal St. Suite 305San Francisco, CA 94107
Correspondence Person	Golnaz Moeini, RACDirector of Quality and RegulatoryArterys Inc.
Contact Information	Email: quality@arterys.comPhone: 408-504-3187
Date Prepared	May 24, 2017

2. Proposed Device

Proprietary Name	Arterys Viewer
Common Name	Viewer
Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Product Code	LLZ
Regulatory Class	II

3. Predicate Device

Primary Predicate

Proprietary Name	HealthMyne PACS
Premarket Notification	K152186
Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Product Code	LLZ
Regulatory Class	II

Reference Device

Proprietary Name	Arterys Software 2.0
Premarket Notification	K162513
Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Product Code	LLZ
Regulatory Class	II

4. Device Description

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the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.

The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis. but it does not directly generate any diagnosis or potential findings.

The following visualization, quantification and data-reporting functionalities are provided by the software:

Visualization:

2D image review -
3D image review by means of MIP, MinIP, Surface or Average -
Multi-planar reconstruction (MPR) views (axial, coronal, sagittal, and oblique) -
Image navigation tools -
Cine play -

Quantification:

Distance and area measurements -

Data reporting:

The distance, area, and user-selected annotated images are displayed to the user within the software client web browser. The user has the option to save the data for later use. The user can also send the data to PACS, for review.

5. Indications for Use

The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

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Image /page/5/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines running parallel to each other. The lines appear to be of equal thickness and are black in color, contrasting with the white background.

6. Comparison of Technological Characteristics with the Predicate and Reference Device

Feature/Function	Proposed Device:Arterys Viewer	Primary PredicateDevice:HealthMyne PACS(K152186)	Reference Device:Arterys Software v2.0(K162513)
SupportMammography	No	No	No
Operating System	Client serverarchitecture usingLinux server and webbrowser client(Web-based only)	Client serverarchitecture utilizingWindows and LinuxPlatforms(Installed-client only)	Client serverarchitecture usingLinux server and webbrowser client(Web-based only)
Image storage/compression	Support JPEG2000and compression	Support JPEG2000and compression	Support JPEG2000and compression
DICOMCompliant	Yes	Yes	Yes
Worklists	Yes	Yes
Filter and Searchcapabilities	Yes	Yes
Ability to searchstudies	Yes	Yes. Dynamic(freeform) search andmatching. Alsocustomized, indexedsearch parameters.
View study-relateddocuments	Yes. Can viewreports/documents(except RT Struct)	Yes. Presentationstates and RT Struct(regions of interest)
Priority "stat"studies	No	Yes. Studies with aDICOM priority tag("Stat" studies) aregiven priority order(top of the list) in theexam view.	No
Managed pushedstudies	Yes. This productsupports only pushedstudies. No studiesoriginate within theproduct	Yes. This productsupport only pushedstudies. No studiesoriginate within theproduct
View current andprior studies at thesame time	No	Yes. Called currentstudy and prior study.Prior studies have alarge "PRIOR" label ineach viewport.	No
Feature/Function	Proposed Device:Arterys Viewer	Primary PredicateDevice:HealthMyne PACS(K152186)	Reference Device:Arterys Software v2.0(K162513)
Re-organize seriesin a study (forviewing)	Yes	Yes. Has a thumbnailview with the ability todrag and drop thethumbnail into aviewport. Cannot savethe order.
Create separatedisplays	Yes	Yes. Can display aviewport as a singleviewport, can select aviewport layout andadd series to it.
Cycle throughseries	Yes	Yes. Can show the"next" and "previous"sets of series
Image displaymodes	Yes. Static and cine	Yes. Static and manualcine.
Select images	Yes. The imagescurrently being viewedare highlighted, andcan be chosen by theuser.	Yes. There is an activeimage indicator. Theactive image can bechosen or isautomatically set basedon tool use.
Delete Images	No	Yes. Only with PACSadmin privileges andfrom the adminconsole.	No
Sort Images	Yes	Yes. Sorting andgrouping are bysystem-defined rules
Scrolling throughslices	Yes	Yes. Linked series arescrolled together. Can"swipe" on a scroll barto move through slicesquickly. Canlock/unlock scrollingthrough every image.
Zoom in/out	Yes. Default settingscan zoom interactively	Yes. Default settingscan zoom interactively
Feature/Function	Proposed Device:Arterys Viewer	Primary PredicateDevice:HealthMyne PACS(K152186)	Reference Device:Arterys Software v2.0(K162513)
Pan an image	Yes	Yes
Standard viewportlayouts	Yes	Yes. Viewport layoutsthat are independent ofany modality orcommon features ofseries
Labels	Yes	Yes. There are labelsin the viewport forpatient, study, andimage information.
Orientation labels	Yes	Yes
Cross-referenceindicator	Yes	Yes. There is a cutlinein linked viewports toindicate intersection
View DICOM data	Yes. You can view theDICOM informationabout the patient andstudy, and the pixelinformation	Yes. You can view theDICOM informationabout the patient andstudy, and the pixelinformation
Create MPRimages	Yes	No. MPRs from theexternal source aresupported/displayed.	Yes
Feature/Function	Proposed Device:Arterys Viewer	Primary PredicateDevice:HealthMyne PACS(K152186)	Reference Device:Arterys Software v2.0(K162513)
Window/leveldetermination	YesSame approach aspredicate but we letthe user adjust W/L	Determined by alookup table function(linear) and the W/Lvalues of the image. Ifthe image has a customlookup table or a fixedW/L, those settings areused instead ofallowing changing ofW/L. If no W/L, then ahistogram is used.
Window/levelaccess series	Yes	Yes. W/L settings areapplied to the activeimage and any linkedimages.
Window/levelpresets	Yes	Yes. Factory default
Adjustwindow/level	Yes. Can interactivelyadjust the window andlevel	Yes. Can interactivelyadjust the window andlevel
Annotation	Yes. Display Only	Yes. Display Only
Measuring tools	Yes. Linear, area, andpixel intensity andlocation of a point	No. Pixel intensity andlocation.	Yes. Linear, area, andpixel intensity andlocation of a point
Feature/Function	Proposed Device:Arterys Viewer	Primary PredicateDevice:HealthMyne PACS(K152186)	Reference Device:Arterys Software v2.0(K162513)
Detectimage/patientissues	No	Yes. Can view patientsand studies with errors	No
Custom filters	Yes. Can set filters toaffect the studies listed	Yes. Can set filters toaffect the studies listed
Set reading state	Yes	Yes. Can mark a studyas read.
Custom searchgroups	Yes	Yes. Can set "codes"to index elements forsearching (forexample, referringphysician or sets ofexam types_ for fasterauto-complete duringsearch
Display radiationtherapyinformation	No	Yes. Supports DICOMRT Structures	No
Surface Rendering	Yes	No	Yes
AnnotationPropagation	Yes	No	Yes
Feature/Function	Proposed Device:Arterys Viewer	Primary PredicateDevice:HealthMyne PACS(K152186)	Reference Device:Arterys Software v2.0(K162513)
Time CurveDisplay	Yes	No	Yes
Contour Creation	Yes	No	Yes
Report Creation	Yes	No	Yes

Arterys Inc., Traditional 510(k)

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Image /page/6/Picture/0 description: The image shows the logo for Arterys. The logo consists of three curved lines on the left side, followed by the word "ARTERYS" in a simple, sans-serif font. The logo is black and white.

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Image /page/8/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a graphic of three curved lines that are parallel to each other. The lines are thin and black, and they create a sense of movement.

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Image /page/9/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines that are parallel to each other. The lines appear to be flowing or waving, adding a dynamic element to the logo.

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7. Substantial Equivalence Summary

Arterys Viewer has the same intended use, indications for use and technological characteristics as the HealthMyne PACS predicate device (K152186). The added features to allow for usability enhancements is similar to the features in the reference device, Arterys Software v2.0, which was cleared by the FDA under K162513. Any noted minor differences have been explained and do not raise any different questions of safety or effectiveness. The implemented design controls, risk management activities, labeling and performed verification and validation tests demonstrate the safety and efficacy of the proposed device. Based on the comparison information provided above. Artervs Viewer is substantially equivalent to the predicate device.

8. Performance Data

Safety and performance of Arterys Viewer has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2008- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."

9. Conclusion

Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, Arterys Viewer raises no new

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questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy and performance.

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).