Vitrea2 is a medical diagnostic system that allows the processing, review, analysis. communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, Vitrea2 Version 3.9 has the following additional indication:

The SUREPlaque™ tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multidetector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.

Device Description

The Vitrea2 system is a medical diagnostic device that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.

The Vitrea2 system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea2 system user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:

. Retrieve image data over the network via DICOM
. Display images that are automatically adapted to exam type via dedicated protocols
Select images for closer examination from a gallery of up to six 2D or 3D views .
Interactively manipulate an image in real-time to visualize anatomy and pathology .
Annotate, tag, measure, and record selected views .
Output selected views to standard film or paper printers, or post a report to an Intranet . Web server or export views to another DICOM device
Retrieve reports that are archived on a Web server .

AI/ML Overview

The provided text describes a 510(k) summary for Vitrea2, Version 3.9 Medical Image Processing Software. It outlines the device description, intended use, predicate device comparison, and a summary of studies. However, it does not contain specific details about acceptance criteria, detailed study designs, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test sets, or training set details.

The provided text focuses on regulatory approval and mentions general software design, development, testing, and validation according to written procedures but does not give specific performance metrics or detailed study results.

Therefore, many of the requested fields cannot be populated from the given information.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not provided in the document. The document states that the software was "designed, developed, tested, and validated according to written procedures," and that "Beta testing/validation will be successfully completed prior to Dlease." However, it does not specify what the acceptance criteria for these tests were, nor does it provide specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) that were met.	Not provided in the document. The document concludes that the device is "substantially equivalent to the predicate devices" and that its changes do not raise "new questions re: safety or effectiveness." This implies that it performs similarly to its predicates, but no quantitative performance data is presented.

Acceptance Criteria

Reported Device Performance

Not provided in the document. The document states that the software was "designed, developed, tested, and validated according to written procedures," and that "Beta testing/validation will be successfully completed prior to Dlease." However, it does not specify what the acceptance criteria for these tests were, nor does it provide specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) that were met.

Not provided in the document. The document concludes that the device is "substantially equivalent to the predicate devices" and that its changes do not raise "new questions re: safety or effectiveness." This implies that it performs similarly to its predicates, but no quantitative performance data is presented.

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

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

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

Adjudication Method: Not specified.

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:

MRMC Study: It is not explicitly stated that an MRMC comparative effectiveness study was done. The phrase "assist trained physicians" in the intended use suggests human-in-the-loop, but no study details are provided to confirm an MRMC design or its results.
Effect Size: Not provided.

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

Standalone Performance Study: No details are provided regarding a standalone performance study. The "SUREPlaque™ tool kit application software package is intended to assist trained physicians," implying human interaction is part of its intended use.

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

Type of Ground Truth: Not specified.

8. The sample size for the training set:

Sample Size for Training Set: Not specified.

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

Ground Truth Establishment for Training Set: Not specified.

Summary of what can be inferred:

The device is "Vitrea2®, Version 3.9 Medical Image Processing Software" with an additional indication for the "SUREPlaque™ tool kit application software package" to assist in the stratification of patients with coronary disease using multidetector Aquilion CT images.
The software was designed, developed, tested, and validated according to internal written procedures.
Beta testing/validation was planned to be completed before release.
The conclusion is that the device is substantially equivalent to its predicate devices and does not raise new questions of safety or effectiveness.

Summary

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

6.0 510(k) Summary

JUN 2 7 2006

Submitter's Name / Contact Person

Timothy J. Kappers, MBA, RAC Director, Quality Systems, Regulatory & Clinical Affairs Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343

General Information

Trade Name	Vitrea2®, Version 3.9 Medical Image Processing Software
Common / Usual Name	System, Image Processing, Radiological
Classification Name	LLZ, Class II, CFR 21 892.2050
Predicate Devices	Vitrea2, Version 3.8 (K052632)Vital Images, Inc. SUREPlaque™ (K043111)Toshiba America Medical Systems, Inc.

Device Description

. Retrieve image data over the network via DICOM
. Display images that are automatically adapted to exam type via dedicated protocols
Select images for closer examination from a gallery of up to six 2D or 3D views .
Interactively manipulate an image in real-time to visualize anatomy and pathology .
Annotate, tag, measure, and record selected views .

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

Output selected views to standard film or paper printers, or post a report to an Intranet . Web server or export views to another DICOM device
Retrieve reports that are archived on a Web server .

Intended Use

Vitrea2® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, Vitrea2 Version 3.9 has the following additional indication:

The SUREPlaque tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post proc sses images obtained using a multidetector Aquilion CT. The package provides tools for t a measurement and visualization (color coded maps) of coronary arteries.

Predicate Device Comparison

The Vitrea2, Version 3.9 system and its predicate devices allow for the analysis, communication a: media interchange of digital images acquired from a variety of acquisition devices. All device support the DICOM protocol for communication of images with other medical imaging devices.

Summary of Stus s

The software utili: I was designed, developed, tested, and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance.

The Vitrea2, Verri testing prior to Bet validation. Software Beta testing/validation will be successfully completed prior to Dlease. In addition, potential hazards have been studied and controlled by a Risk Management Plan.

Conclusion

The Vitrea2, Versi very similar techn:

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

ling safety or effectiveness of the device. Thus, the Vitrea2, Version 3.9 new questions re: ·'ly equivalent to the predicate devices. system is substar.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 2 7 2006

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

Re: K061624

Trade/Device Name: Vitrea26, Version 3.9 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 8, 2006 Reccived: June 12, 2006

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006" in a circular design. Below the logo, the text "Protecting and Promoting Public Health" is displayed in a decorative font. The logo appears to be a commemorative emblem for the FDA's centennial anniversary.

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

Page 2 -

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); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

3.0 Intended Use Statement

510(k) Number (if known): 《んしくんとイ Device Name: Vitrea2 , Version 3.9 Medical Image Processing Software

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of of a

Laird A. Lynam

(Division Sie. Off) · Septoductive, Abdominal rest revices

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).