Vitrea™2 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, Vitrea™2 has the following specific indications.

VScore™ (K990442) is an option within the Vitrea™2 application and is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate (K001682) and Auto Gate (K003230), allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.

Automated Vascular Measurement (K002519) is an option within the Vitrea™2 application and is intended for study/analysis of selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity evaluation.

Tumor Volume Measurement (K002519) is an option within the Vitrea™2 application and is intended for the analysis/quantification of tumor volumes obtained from MR brain series scans.

CT Brain Perfusion (K003639) is an option within the Vitrea™2 application and is intended for post processing based on dynamic CT images continuously acquired during the injection of contrast for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion related parameters to aid in the type and extent of cerebral perfusion disturbances.

ImageCheckerCT is an option within the Vitrea™2 application and is intended for the display of a composite view of 2D crosssections, and 3D volumes of Chest CT images, including findings of regions of interest ("ROI") identified by the radiologist, or Computer Assisted Detection ("CAD") findings.

Device Description

Vitrea™2 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea™2, version 3.4 is an upgrade to Vitrea™2, version 2.1 initially released for commercial distribution by FDA on K002519.

Vitrea 2 provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea2 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

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The provided document is a 510(k) Summary for Vitrea2, Version 3.4. It declares substantial equivalence of the device to predicate devices rather than providing detailed acceptance criteria and a performance study with quantitative metrics.

The document states: "The Vitrea2, Version 3.4 Workstation will successfully complete Integration testing/verification prior to Beta validation. The software Beta testing validating the workstation will be successfully completed prior to release." This indicates that internal testing and validation were conducted, but specific metrics, acceptance criteria, or the results of those tests are not provided in this summary.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and ground truth establishment for a standalone or comparative effectiveness study are not available in this document. The summary focuses on comparing the new device's intended use and technological characteristics to previously cleared predicate devices to establish substantial equivalence.

Based on the information available, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the 510(k) Summary. The document asserts the device's functionality and safety through comparison to predicate devices and general software development processes, but does not list specific quantitative acceptance criteria or corresponding performance scores for any of its features (VScore, Automated Vascular Measurement, Tumor Volume Measurement, CT Brain Perfusion, or ImageCheckerCT).

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

Not provided in the 510(k) Summary. There is no mention of a specific test set, its size, or the provenance of the data used for any validation studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not provided in the 510(k) Summary. The document does not detail how ground truth was established for any testing, nor does it specify the number or qualifications of experts involved.

4. Adjudication Method for the Test Set

Not provided in the 510(k) Summary. There is no mention of an adjudication method for any test set.

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

No MRMC comparative effectiveness study is reported in this 510(k) Summary. The document focuses on demonstrating substantial equivalence to predicate devices, not on quantifying the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study with specific metrics is reported in this 510(k) Summary. The document describes a medical diagnostic workstation with various processing options to aid clinicians, implying human interaction. It does not provide data on the pure automated performance of its features.

7. Type of Ground Truth Used

Not explicitly stated in the 510(k) Summary. Given the nature of the device (medical image processing software for diagnosis), if ground truth were used, it would typically be based on expertconsensus, pathological findings, or clinical outcomes, but the document does not specify this.

8. Sample Size for the Training Set

Not provided in the 510(k) Summary. There is no mention of a training set or its size. This document is from 2003, predating the widespread use and specific regulatory requirements for detailing AI/ML model training data that are common today.

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

Not provided in the 510(k) Summary. As no training set is mentioned, the method for establishing its ground truth is also not provided.

Summary

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Attachment 1 - 510(k) Summary

Submitter's Name / Contact Person

Stephen S. Andersen Sr. Director of Quality and Customer Satisfaction Vital Images, Inc. 3300 Fernbrook Lane N, Suite 200 Plymouth, MN 55447

General Information

Trade Name	Vitrea2, Version 3.4 Medical Image Processing Software
Common / Usual Name	System, Image Processing, Radiological
Classification Name	LLZ, Class II, CFR 21 892.2050
Predicate Devices	Vital Images, Inc., Vitrea2, Version 2.1 (K002519)GE, Advantage Workstation 4.1 (K020483)R2 Technologies, Inc., ImageChecker-CT Workstation (K023003)GE, Advanced Lung Analysis (K013381)

Device Description

Vitrea™2 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea™2, version 3.4 is an upgrade to Vitrea™2, version 2.1 initially released for commercial distribution by FDA on K002519.

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 .

Intended Use

Vitrea™2, Version 3.4 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, VitreaTM2 has the following specific indications.

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VScore™ (K990442) is an option within the Vitrea™2 application and is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection of atherosclerotic plaque. Two image processing options. EKG Gate (K001682) and Auto Gate (K003230), allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.

Tumor Volume Measurement (K002519) is an option within the Vitrea™2 application and is intended for the analysis/quantification of tumor volumes obtained from MR brain series scans.

CT Brain Perfusion (K003639) is an option within the Vitrea™2 application and is intended for post processing based on dynamic CT images continuously acquired during the injection of contrast for the visualization of apparent blood flow in brain tissue and pictorial illustration related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.

ImageCheckerCT is an option within the Vitea™2 application and is intended for the display of a composite view of 2D cross-sections, and 3D volumes of Chest CT images, including findings of regions of interest ("ROI") identified by the radiologist, or Computer Assisted Detection ("CAD") findings.

Predicate Device Comparison

The Vitrea2, Version 3.4 Workstation and the predicate devices allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices support the DICOM protocol for communication of images with other medical imaging devices.

Summary of Studies

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

The Vitrea2, Version 3.4 Workstation will successfully complete Integration testing/verification prior to Beta validation. The software Beta testing validating the workstation will be successfully completed prior to release. In addition, potential hazards have been studied and controlled by a Risk Management Plan.

Conclusion

The Vitrea2, Version 3.4 Workstation has the same intended use as the predicate devices and very similar indications and technological characteristics. Any technological differences do not raise any new questions regarding safety or effectiveness. Thus, the Vitrea2, Version 3.4 Workstation is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows a circular logo with an abstract depiction of an eagle in the center. The eagle is composed of three curved lines that suggest its head, body, and wings. Encircling the eagle is text that reads 'DEPARTMENT OF HEALTH & HUMAN SVC'. The text is arranged along the circumference of the circle, with 'DEPARTMENT' at the bottom left and 'SVC' at the top right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2003

Mr. Stephen S. Anderson Sr. Director, Quality and Customer Satisfaction Vital Images, Inc. 3300 Fernbrook Lane North, Suite 200 PLYMOUTH MN 55447-5341

Re: K032748

Trade/Device Name: Vitrea2, Version 3.4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: September 4, 2003

Received: September 5, 2003

Dear Mr. Anderson:

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 (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); 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.

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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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ 11 6 3 27 48

Device Name: Vitrea™2, Version 3.4 Medical Image Processing Software

Indications for Use:

Tumor Volume Measurement (K002519) is an option within the Vitrea™2 application and is intended for the analysis/quantification of tumor volumes obtained from MR brain series scans.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓

David A. Symm

Division of Reproductive, Abdom and Radiological Devices 510(k) Number

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).