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The Rotium Bioresorbable Wick is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.

The Rotium™ Bioresorbable Wick is an accessory to be used in conjunction with suture anchors for rotator cuff repair. The wick is placed between the bone and is designed to facilitate tendon-bone attachment. The wick is an electrospun, non-woven, microporous, microfiber matrix. The wick is made from two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). The wick is packaged in a primary foil pouch with a desiccant pouch, sealed within a secondary Tyvek pouch. The device is supplied gamma-sterilized. The device is single use only.

The provided document is a 510(k) summary for the Rotium Bioresorbable Wick. It outlines the device's technical characteristics, intended use, and substantial equivalence to a predicate device based on various non-clinical tests. However, it does not describe a study with acceptance criteria and a detailed comparison of device performance against those criteria in the context of an algorithmic or AI-enabled device.

The requested information (acceptance criteria, reported device performance, sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is typically associated with the rigorous validation of AI/ML or image-based diagnostic devices. This document describes a medical device (a bioresorbable wick) that is physically implanted, and its substantial equivalence is based on biocompatibility, bench testing, and animal testing, not on an algorithm's performance.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is for a physical medical device and not for an AI/ML or software as a medical device (SaMD) that would require such performance criteria and studies.

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