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The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder. Specifically, rotator cuff repairs.

The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is a fully threaded knotless suture anchor that is pre-loaded on a disposable inserter with Arthrex sutures. The anchor may be manufactured from either BioComposite (PLLA/betaTCP TriCalcium Phosphate) or PEEK (Polyether-ether-ketone). The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is provided sterile (Ethylene Oxide), single-use, and is packaged in a single-pack or 5-pack.

The provided document is an FDA 510(k) clearance letter for a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The "Performance Data" section of the 510(k) summary (page 4) states:
"Tensile (pull-out) testing was conducted on the proposed Arthrex 4.75 mm Doubled Loaded Knotless Corkscrew Suture Anchor submitted in this Special 510(k). The test data demonstrates that the proposed device performs statistically equivalent to the predicate device for the intended indications for use. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that mechanical and biocompatibility tests were performed, but no acceptance criteria or detailed study results for an AI/ML device performance are present. The document is for a physical medical device (suture anchor), not an AI/ML-driven diagnostic or therapeutic tool. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/ML system cannot be extracted from this document.

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