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Vitrea™ 2 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 acquisition devices. In addition, the Vitrea™ 2, Version 3.7 has the following additional indications:

CT Colonography The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, simultaneous display of prone and supine images, and transparent wall view.

CT Cardiac The separately-licensed CT Cardiac option contains two components: Coronary Artery Analysis and Cardiac Functional Analysis. The Vital Images CT Cardiac provides a variety of tools and views for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.

Coronary Artery Analysis The Coronary Artery Analysis component of the Vitrea CT Cardiac option is intended for determining the presence and extent of coronary obstructive disease by providing a non-invasive approach to survey a patient's coronary arteries. The vessel probe technology integrated into the CT Cardiac option allows physicians' to click on an artery to simultaneously view the highlighted vessel in 3D, two curved vessel views orthogonal to each other, and cross-sectional views.

Cardiac Functional Analysis The Cardiac Functional Analysis (CFA) component of the Vitrea CT Cardiac option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function which producing a cardiac evaluation. The CFA component of the CT Cardiac option includes semi-automatic heart and left ventricle segmentation, including identification of long axis and mitral valve plane across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots.

Lung Analysis The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.

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 acquisition devices. Vitrea2, Version 3.7 is an upgrade to Vitrea2, Version 3.5 (cleared under K040305).

The Vitrea2 system provides multi-dimensional visualization of digital images to aid clinicians in the diagnosis of disease 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 . Output Selectorer or export views to another DICOM device
• Retrieve reports that are archived on a Web server .

The provided text is a 510(k) summary for the Vitrea2, Version 3.7 Medical Image Processing Software. It describes the device, its intended use, and a comparison to predicate devices. However, it does not explicitly contain detailed acceptance criteria or a study that proves the device meets those criteria in the format requested.

The document states:

• "The software utilized was designed, tested, and validated according to written procedures."
• "The Vitrea2, Version 3.7 system will successfully complete integration testing prior to Beta validation."
• "Software Beta testing/validation will be successfully completed prior to release."
• "potential hazards have been studied and controlled by a Risk Management Plan."

These statements indicate that testing and validation occurred, but specifics regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, or expert involvement in a formal study are not provided. The document focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than presenting a performance study with detailed numerical results against predefined acceptance criteria.

Therefore, I cannot populate the requested table or provide the specific details of a performance study as the information is not present in the provided text. The summary explicitly states that minor technological differences "do not raise any new questions" and that the system "is substantially equivalent to the predicate devices," implying that rigorous performance testing against numerical acceptance criteria was not deemed necessary to establish substantial equivalence in this 510(k) submission.

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