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Vitrea Software Toshiba Package is an application package developed for use on Vitrea, a medical image processing software, which includes the following post-processing software applications.

CT/XA Cerebral Artery Morphological Analysis This software is intended to facilitate the extraction and seqmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

MR Wall Motion Tracking This application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and reqional myocardial function that is used for patients with suspected heart disease.

Vitrea Software Toshiba Package, VSTP-001A, an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images. Inc. Vitrea Software Toshiba Package, VSTP-001A, includes two post processing applications, CT/XA Cerebral Artery Morphological Analysis and MR Wall Motion Tracking, which use brain and cardiac image data, obtained from CT/XA/MR systems, to assist physicians in performing specialized measurements and analysis.

Here's a breakdown of the acceptance criteria and study information for the Vitrea Software Toshiba Package, VSTP-001A, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device includes two main applications: CT/XA Cerebral Artery Morphological Analysis and MR Wall Motion Tracking. The document describes the performance of a test but doesn't explicitly list "acceptance criteria" as a defined threshold value for each metric. Instead, it states that the studies demonstrated the device performed as intended and met required success ratios compared to manual methods or prior versions.

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

• CT/XA Cerebral Artery Morphological Analysis: The document mentions "clinical evaluations" and "bench studies using numerical phantoms." It does not specify the sample size for either the clinical evaluations or the numerical phantom studies.
• MR Wall Motion Tracking: Similar to the CT/XA application, "clinical evaluations" and "bench studies using numerical phantoms" were conducted. The sample size is not specified for either.
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It only mentions "clinical evaluations."

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

The document does not specify the number of experts used or their specific qualifications for establishing ground truth for the test set. It mentions "manual measurements and/or segmentations" for the CT/XA application, implying expert human input, but details are absent.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, the document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the device's performance compared to manual methods or prior versions, but not on how human readers improve with AI versus without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, standalone (algorithm only) performance seems to have been evaluated. The benchmarking using "numerical phantoms" and assessment of "accuracy of extraction/display" and "measurement calculations" for the CT/XA application, and "cardiac function and strain" for the MR application, suggests standalone testing. The statement about "contour tracking process... met the required success ratio" for MR Wall Motion Tracking also implies standalone algorithm evaluation.

7. The Type of Ground Truth Used

• CT/XA Cerebral Artery Morphological Analysis: The ground truth appears to be based on expert human measurements and/or segmentations ("comparable to manual measurements and/or segmentations") and numerical phantoms for accuracy.
• MR Wall Motion Tracking: The ground truth also seems to be based on numerical phantoms for accuracy analysis of cardiac function and strain, and an "intended" or "required success ratio" for contour tracking, which would likely be established against a reference standard or expert review.

8. The Sample Size for the Training Set

The document does not mention the sample size for the training set for either application. It focuses on verification/validation testing.

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

The document does not provide information on how the ground truth for the training set was established, as it does not discuss the training process or dataset.

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