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Arthrex FiberTape and TigerTape cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

When used as bone fixation cerclage the sutures are intended for:

• · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty
• · Sternotomy indications including the "rewiring" of osteomized sternums
• · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
• Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
  ·Repair of long bone fractures due to trauma or reconstruction

The proposed Arthrex FiberTape and TigerTape Cerclage devices are available as a flat braided suture assembled in a loop configuration. Cerclage is assembled on an HDPE card or on an ABS loader. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials. These materials are identical to those cleared in K170206. For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double loop.

This document is a 510(k) summary for the Arthrex FiberTape and TigerTape Cerclage Sutures. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to a predicate device. This is a medical device submission, not a study of an AI/ML powered device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI/ML powered device.

The document discusses mechanical testing and bacterial endotoxin testing to demonstrate that modifications do not negatively impact mechanical strength or pyrogen limits, which are typical for physical medical devices. It also mentions "clinical literature was provided to justify the testing conditions and acceptance criteria of the subject Arthrex Cerclage Sutures," but it does not detail these criteria or the results of a clinical study, particularly not one involving AI/ML.

Therefore, I cannot provide the requested information. The prompt asks for details about an AI/ML powered device study, but the provided text describes a submission for a physical medical device (sutures).

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