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The Bone Reduction Screw is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.

The ARC Surgical Bone Reduction Screw is a headless, cannulated twopiece screw assembly. The two-piece design incorporates the use of a distal and proximal screw component. The implant is used to anatomically reduce two bone portions. The distal screw component engages the distal bone portion and the proximal screw component engages the proximal bone component.

The provided text makes no mention of an AI/ML device or its performance criteria. The submission is for a "Smooth or threaded metallic bone fixation fastener" named the "Arc Surgical Bone Reduction Screw System." The document primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device. The document explicitly states: "A discussion of clinical and non-clinical tests is not applicable." because the device is a simple mechanical device with well-established uses.

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