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TAPESTRY® Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

The TAPESTRY® Biointegrative Implant is composed of collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. The implant is provided sterile for single use only. It is supplied as a standalone implant, in an insertion sleeve, or on an introducer assists in delivering the implant to the surgical site during arthroscopic procedures. The device is provided in a dual pouch configuration.

This document is an FDA 510(k) summary for the TAPESTRY® Biointegrative Implant. It outlines the device, its intended use, and compares it to a predicate device. However, it does not describe acceptance criteria, nor does it present a study that proves the device meets specific performance criteria related to AI/algorithm performance.

The performance data section explicitly states: "The testing in this submission was directly applicable to the new introducer and no additional performance testing was required for the implant based on the modification." This indicates that the reported performance data focuses on the mechanical aspects of the introducer instrument, rather than clinical efficacy or AI/algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI/algorithm, as the provided document does not contain such details. It pertains to a physical medical device (an implant and its introducer) and its regulatory clearance based on substantial equivalence to a predicate device.

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