VitreaView is a medical image viewing and information application that provides access, through the Internet and within the enterprise, to multi-modality softcopy medical images, reports and other patient-related information, that may be hosted within disparate archives and repositories for review, communication and reporting of DICOM and non-DICOM data. VitreaView is not intended for primary diagnosis.

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

VitreaView is a cross-browser, cross-platform zero-footprint universal image viewer solution capable of displaying both DICOM and non-DICOM medical images. VitreaView enables referring clinicians and other medical professionals with access to patients' medical images in a seamless way, with integrations into their Electronic Health Record (EHR), Electronic Medical Record (EMR), and Health Information Exchange (HIE)

VitreaView offers medical professionals a universal viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero-footprint, zero download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases.

Some of the general features include:

2D multi-modality review of data .
. Basic 2D review tools (zoom, pan, measure)
Easy study navigation .
Comparative review .
Displays of DICOM and non-DICOM images .
A scalable, virtualizable infrastructure .
Cross-platform viewing capabilities (Windows, Mac OS, etc.) .
Leveraging of next-generation protocols for image viewing (i.e. MINT) .
Single sign-on . .
EMR integration ●

AI/ML Overview

The provided text is a 510(k) summary for VitreaView, a medical image viewing software. However, it does not contain specific acceptance criteria, a detailed study protocol for performance claims, or quantitative data demonstrating device performance against such criteria.

Instead, the document focuses on:

Substantial Equivalence: Arguing that VitreaView is substantially equivalent to a predicate device (Cedara WebAccess™) based on similar indications for use and "essentially identical technological characteristics."
Design and Testing Philosophy: Stating that the software was "designed, developed and tested according to written procedures" and that "Software testing was completed to insure the new feature function according to the requirements and interacts without impact to existing functionality."

Since the document explicitly states, "The test results support a determination of substantial equivalence," but does not provide a summary of said test results, specific acceptance criteria, or performance metrics, I cannot fulfill most of your requests directly from the provided text.

Here's what I can extract and what I cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document (The document only states "The test results support a determination of substantial equivalence" without detailing the results or the criteria they met.)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method:

Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not mentioned or implied. The document focuses on the device's functionality and equivalence to a predicate, not comparative effectiveness with human readers.

6. Standalone Performance Study (Algorithm Only):

This is an image viewer and information distribution application, not an AI algorithm for diagnosis. Therefore, a "standalone algorithm performance" study as typically understood for AI diagnostic tools would not be applicable or expected. The document implies functional testing of the software itself.

7. Type of Ground Truth Used:

Given it's a viewer that integrates with EHR/EMR and displays DICOM/non-DICOM data, the "ground truth" for its functional testing would likely revolve around:
- Correct display of various image formats (DICOM, non-DICOM).
- Accurate functionality of basic 2D review tools (zoom, pan, measure).
- Successful navigation and comparative review.
- Integration capabilities (EMR, HIE).
- Data integrity during transfer and display.
However, the document does not explicitly state the type of ground truth used for performance validation.

8. Sample Size for the Training Set:

As a viewer and not an AI/ML algorithm that learns from data, there isn't a "training set" in the conventional sense for this device. Functional testing would involve various types of medical images and data, but not a dataset for model training.

9. How Ground Truth for the Training Set Was Established:

Not applicable for a non-AI/ML device.

In summary: The provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence. It confirms that internal software testing was performed to ensure functionality, but it does not provide the detailed public study results, acceptance criteria, or performance metrics typically requested for a detailed AI/ML device analysis. The device itself is a medical image viewer, not an AI diagnostic tool, so many of the questions (e.g., training set, reader studies) are not directly applicable.

Summary

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

SUMMARY OF SAFETY AND EFFECTIVE USE

510(k) Number: K|||892

JUL 2 8 2011

Date Prepared: 31 May 2011

Submitter Information

Submitter:	Vital Images, Inc.
Street Address:	5850 Opus Parkway Suite 300Minnetonka, MN 55343-4414
Establishment registration:	2134213
Owner/Operator #:	9024582
Contact Person:	Ian Nemerov
	Vice President, General Counsel &Secretary
Phone:	(952) 487-9622
Fax:	(952) 487-9510
Email:	inemerov@vitalimages.com

Device Information

Trade Name	VitreaView
Common Name	Radiological Image Processing Software
Classification Name	System, Image Processing, Radiological
Regulation /Product Code	21 CFR 892.2050
Product Code	LLZ
Regulatory Classification:	Class II
Device Panel:	Radiology

VitreaView is substantially equivalent to the previously-cleared, web-based software Cedara WebAccess™

Predicate Device

Predicate Device	Manufacturer	FDA 510(k)
Cedara WebAccess™	Cedara Software Corp.Mississauga, Ontario, Canada	K092915

Device Description

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

download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases.

Some of the general features include:

2D multi-modality review of data .
. Basic 2D review tools (zoom, pan, measure)
Easy study navigation .
Comparative review .
Displays of DICOM and non-DICOM images .
A scalable, virtualizable infrastructure .
Cross-platform viewing capabilities (Windows, Mac OS, etc.) .
Leveraging of next-generation protocols for image viewing (i.e. MINT) .
Single sign-on . .
EMR integration ●

Intended Use/Indications for Use

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

Summary of Testing

The software was designed, developed and tested according to written procedures. Software testing was completed to insure the new feature function according to the requirements and interacts without impact to existing functionality. The test results support a determination of substantial equivalence.

Conclusions

VitreaView has similar indications for use as the predicate device and essentially identical technological characteristics. Minor feature differences do not raise any new questions regarding safety or effectiveness of the device. The VitreaView software performs as intended, and presents no unacceptable risks to the intended patient population or end user. VitreaView is substantially equivalent to the predicate device.

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

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of a human figure or a caduceus. The text is in a clear, sans-serif font and is horizontally aligned.

Public Health Service

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

Vital Images, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

JUL 28 2011

Re: K111892

Trade/Device Name: VitreaView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture arching and communications system Regulatory Class: II Product Code: LLZ Dated: July 1, 2011 Received: July 5, 2011

Dear Mr. Job:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) number (if known) (< ( | | 892

Device Name: VitreaView

Indications for Use:

VitreaView is a medical image viewing and information distribution application that provides access, through the Internet and within the enterprise, to multi-modality softcopy medical images, reports and other patient-related information, that may be hosted within disparate archives and repositories for review, communication and reporting of DICOM and non-DICOM data. VitreaView is not intended for primary diagnosis.

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

MhhmADÓhm

ivision Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safet 510(k) Page 1 of

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).