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Tendon Wrap™ Tendon Protector is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Tendon Wrap is an absorbable implant (device) that provides a non-constricting, protective encasement for injured tendons, it is comprised of a porous matrix of cross-linked bovine Type I collagen and glycosaminoglycan (GAG). "Tendon Wrap is designed to serve as an interface between the tendon sheath or the surrounding tissues. Tendon Wrap is an easy to handle, conformable, porous collagen-GAG sheet designed for easy placement under, around or over the injured tendon. Tendon Wrap is supplied sterile, non-pyrogenic, for single use, in double peel packages in a variety of sizes.

The provided 510(k) summary for the Tendon Wrap™ Tendon Protector does not describe specific acceptance criteria and detailed study results in a format that would typically be found for AI-based medical devices. This document is for a medical device (a tendon protector) and not for an AI/ML-driven device. As such, the information you're requesting regarding acceptance criteria from AI studies, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets, and data provenance is not applicable or present in this K053655 submission.

The document focuses on:

• Substantial Equivalence: Demonstrating that the Tendon Wrap™ is substantially equivalent to previously cleared devices (NeuraWrap® Nerve Protector and Medist International Tendon Spacer) based on its function and intended use.
• Device Description: What the device is made of and how it works (porous matrix of cross-linked bovine Type I collagen and glycosaminoglycan).
• Intended Use: For the management and protection of tendon injuries without substantial tissue loss.
• Testing and Test Results (General): It broadly mentions "Biocompatibility studies," "physical testing," "animal studies," and "clinical experience" have demonstrated safety and effectiveness and that the device provides a protective interface that improves mobility of repaired tendons. However, it does not provide specific acceptance criteria values (e.g., sensitivity, specificity, AUC) or the detailed results of these studies.
• Conclusion: Reinforcing safety and effectiveness based on physician experience with the material, animal testing, biocompatibility, and physical property testing.

Therefore, it is not possible to extract the requested information (points 1-9) as it pertains to AI/ML device studies from this document. This 510(k) submission precedes widespread AI/ML medical device regulation and focuses on traditional device clearance pathways.

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