Vitrea 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. Vitrea is not meant for primary image interpretation in mammography. In addition, Vitrea Version 4.0 has the following additional indications:

Cardiac EP Planning is a post-processing advanced visualization that is intended to be used for the analysis and assessment of the heart including the atria, pulmonary veins, and coronary sinus. The application provides analysis tools which include a number of display, quantitative measurement and 3D model export capabilities for use with the St. Jude Ensite® System. The application can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.

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

The Vessel Probe option is intended for viewing the anatomy and pathology of a patient's peripheral arteries. Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard Vitrea software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.

Device Description

The Vitrea 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 Vitrea system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea 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 document, K071331 for Vitrea®, Version 4.0 Medical Image Processing Software, does not contain the detailed information required to fill out the table and answer all the questions regarding acceptance criteria and a specific study proving it.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

No specific acceptance criteria or reported device performance metrics are provided in the document. The document states that the software "will successfully complete integration testing/verification testing prior to Beta validation" and "Software Beta testing/validation will be successfully completed prior to release," but it doesn't specify what those "successful" criteria are (e.g., minimum accuracy rates, precision, etc.) for its various functions (Cardiac EP Planning, SUREPlaque, Vessel Probe).

Study Details

Given the lack of a specific study to prove acceptance criteria, most of these questions cannot be answered.

Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. The document focuses on demonstrating substantial equivalence to predicate devices, not on comparing reader performance with and without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The intended use for several features (Cardiac EP Planning, SUREPlaque, Vessel Probe) implicitly involves trained physicians for analysis and assessment, suggesting a human-in-the-loop scenario.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary of Findings from the Document:

The K071331 submission for Vitrea®, Version 4.0 is a 510(k) premarket notification. The primary goal of a 510(k) is to demonstrate substantial equivalence to a currently marketed predicate device, rather than to independently establish the safety and effectiveness of the new device through extensive clinical trials with predefined acceptance criteria.

The document states:

"The software utilized was designed, developed, tested, and validated according to written procedures."
"The Vitrea, Version 4.0 system will successfully complete integration testing/verification testing prior to Beta validation."
"Software Beta testing/validation will be successfully completed prior to release."
"The Vitrea, Version 4.0 system has similar intended uses as the predicate devices and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, the Vitrea, Version 4.0 system is substantially equivalent to the predicate devices."

This indicates that internal testing and validation were performed, but the details of these tests, including specific acceptance criteria, sample sizes, ground truth establishment, or clinical performance metrics, are not included in this publicly available 510(k) summary. These details would typically be found in the full 510(k) submission, which is not usually made public in its entirety.

Summary

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K071331

6.0 510(k) Summary

Submitter's Name / Contact Person

MAY 2 5 2007

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	Vitrea ®, Version 4.0 Medical Image ProcessingSoftware
Common / UsualName	System, Image Processing, Radiological
Classification Name	LLZ, Class II, CFR 21 892.2050
Predicate Devices	• Vitrea®, Version 3.9 (K061624)Vital Images, Inc.
	• EnSite Verismo™ (K051840)St. Jude, Inc.
	• CARD EP (K031261)GE Medical Systems
	• 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 �

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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 .

Intended Use

Predicate Device Comparison

The Vitrea, Version 4.0 system and its predicate devices allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices. All devices support the DICOM protocol for communication of images with other medical imaging devices.

Page 27

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Summary of Studies

The software utilized 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 Vitrea, Version 4.0 system will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release. In addition, potential hazards have been studied and controlled by a Risk Management Plan.

Conclusion

The Vitrea, Version 4.0 system has similar intended uses as the predicate devices and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, the Vitrea, Version 4.0 system is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

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

Re: K071331

Trade/Device Name: Vitrea®, Version 4.0 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 10, 2007 Received: May 11, 2007

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 Corneric Act (Act) that do not require approval of a premarket approval application (PMA). You costi. 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 levelocal 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 affective 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 is a black and white circular logo. The logo contains the letters "DA" in a bold, sans-serif font. Above the letters, the numbers "1888-1988" are printed. Below the letters, the word "Centennial" is printed in a cursive font. There are four stars at the bottom of the logo.

Protecting and Promoting Public Health

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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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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

Enclosure

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Vital Images, Inc. Vitrea™ Version 4:0

3.0 Intended Use Statement

610(k) Number (if known): KOJ 133 Device Name: Vitrea , Version 4.0 Medical Image Processing Software

Vitrea 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. Vitrea is not meant for primary Image interpretation in mammography. In addition, Vitrea Version 4.0 has the following additional indication:

Cardiac EP Planning is a post processing advanced visualization application that is intended to be used for the analysis and assessment of the heart including the atria, pulmonary veins, and coronary sinus. The application provides analysis tools which include a number of display, quantitative measurement and 3D model export capabilities for use with the St. Jude Ensite® System. The application can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.

The Vessel Probe option is intended for viewing the anatomy and pathology of a patient's peripheral arteries. Clinicians can select any artery to view the following anatomical portional arterloor unities vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional at angles on to calned using standard Vitrea software measuring tools. Clinicians modeline attematically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unlt or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.

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

AND/OR

Over-The-Counter Use (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)

Nancy brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K07133/

Page	of
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May 04, 2007 Abbreviated 510{k} Premarket Notification

Page 10

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).