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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. Vitrea2 Version 3.8.1 adds the following previously FDA-cleared software applications to the currently marketed Vitrea2 system: Fusion7D, RTist, ImageChecker CT Lung v2.0 System, AutoPoint Temporal Comparison Tool, and the Pulmonary Artery PE (Patency Exam).

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 user interface follows typical clinical workflow patterns to process, review, and analyze digital images.

The provided text describes the Vitrea2®, Version 3.8.1 Medical Image Processing Software and its substantial equivalence to predicate devices, but it does not contain the specific details about acceptance criteria or a dedicated study proving the device meets those criteria for the Vitrea2 system itself.

Instead, the document primarily focuses on:

• Device Description: What the Vitrea2 system does.
• Intended Use: The purpose of the Vitrea2 system and its added functionalities (Fusion7D, RTist, ImageChecker CT Lung v2.0 System, AutoPoint Temporal Comparison Tool, Pulmonary Artery PE).
• Predicate Device Comparison: How Vitrea2 compares to other legally marketed devices.
• Summary of Studies: A general statement about design, development, testing, and validation according to written procedures, integration testing, Beta testing, and risk management.
• Conclusion: The device is substantially equivalent to predicate devices.
• FDA Clearance Letter: Formal FDA clearance.

The "Summary of Studies" section provides a high-level overview of their development and testing process, but it does not detail performance metrics or studies using specific acceptance criteria, sample sizes, or ground truth methodologies that would typically be presented for a detailed performance study. It mentions internal testing and "Beta validation" but does not provide results from these.

Therefore, for your request, I can only provide what can be inferred or directly stated from the text, and will explicitly state what information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

• "The software utilized was designed, developed, tested, and validated according to written procedures."
• "The Vitrea2, Version 3.8.1 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."
• It concludes the device is "substantially equivalent" to predicates. |

Missing Information: Specific quantitative or qualitative acceptance criteria (e.g., accuracy thresholds, precision values, specific clinical endpoints) are not provided. The document does not report performance metrics against any defined acceptance criteria.

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

Missing Information: The document states that "integration testing" and "Beta testing/validation" were successfully completed, but it does not specify the sample size of cases or images used for these tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature).

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

Missing Information: The document does not mention the use of external experts for establishing ground truth for any test set, nor does it specify their number or qualifications.

4. Adjudication Method for the Test Set

Missing Information: As no specific test set or expert ground truth establishment is detailed, no adjudication method is mentioned.

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

Missing Information: The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated, nor does it provide an effect size for such a study.

6. Standalone (Algorithm Only) Performance Study

Missing Information: While the device has functionalities for image processing and analysis, the document does not describe a standalone performance study specifically for an algorithm without human-in-the-loop performance measurement. The descriptions for some of the added functionalities (like ImageChecker CT Lung) sound like CAD systems, which often have standalone performance studies, but no such details are provided for the Vitrea2 system or its components in this document.

7. Type of Ground Truth Used

Missing Information: The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for any of its internal testing or validation.

8. Sample Size for the Training Set

Missing Information: The document does not provide any details about a training set, its size, or its composition. This suggests the Vitrea2 system (or at least the core system described here) may not rely on a machine learning model that requires a dedicated training set in the way a modern AI/CAD system would. It appears to be more of an image processing and visualization platform.

9. How Ground Truth for the Training Set Was Established

Missing Information: As no training set is mentioned, naturally, the method for establishing its ground truth is also not provided.

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