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The Scout Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.

The Scout Vessel Guard is a permanent, non-absorbable membrane made of hydrogel. It is packaged wet in phosphate buffered saline (PBS). This device is designed to be placed between the anterior spine and proximate vessels during anterior lumbar surgery, and is flexible, allowing it to contour to the anatomy. The Scout Vessel Guard can be affixed to bone and/or soft tissue.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synthes Scout Vessel Guard:

Acceptance Criteria and Device Performance for Synthes Scout Vessel Guard

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not explicitly state the sample sizes used for each test. The studies mentioned are non-clinical (benchtop/materials testing) and a cadaver lab for usability. Therefore, the data provenance is from laboratory tests and cadaveric studies, not human patient data, and thus, country of origin is not applicable in the typical sense. The studies appear to be prospective in their execution, as they were conducted to verify the device's performance.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document. For the non-clinical and cadaveric studies, "ground truth" would likely be established by engineering standards and anatomical observations rather than expert consensus on patient data.

4. Adjudication Method for the Test Set:

This information is not provided in the document. As the studies were non-clinical and cadaveric, an adjudication method in the traditional sense for human patient data (e.g., 2+1 radiologist review) would not be applicable.

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

No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical data was not needed for this device." This indicates that studies involving human readers and clinical cases were not part of the submission to demonstrate effectiveness or comparing human performance with and without AI assistance.

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

Based on the provided information, the device is a physical medical device (a vessel guard made of hydrogel). Therefore, the concept of an "algorithm only" or "standalone" performance for AI does not apply. The device itself is the primary component, and its performance is evaluated through material and mechanical testing, and usability in a cadaveric setting.

7. Type of Ground Truth Used:

The ground truth used for this device's acceptance was based on:

• Engineering specifications and standards: For suture retention, tensile strength, pore size, and material stability.
• Biocompatibility standards (ISO 10993): For biological safety.
• Anatomical and surgical observations: For usability in a cadaver lab, ensuring the device could be placed and contoured as intended.

8. Sample Size for the Training Set:

This information is not applicable. The Synthes Scout Vessel Guard is a physical medical device, not an AI or software device that undergoes training with a dataset.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable, as the device is not an AI or software device that requires a training set.

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