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The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:

1. Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
2. Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
3. Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle.

The Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

The Mini TightRope is designed as either two metal buttons with a pre-threaded FiberWire suture or as one metal button, one bioabsorbable suture anchor with one pre-threaded FiberWire suture.

The provided text is a 510(k) summary for the Arthrex Mini TightRope device. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance and does not contain information about acceptance criteria or specific study results to prove device performance in the context of AI/machine learning.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and study results, as this type of data is not present in the provided document. The document describes a medical device, its intended use, and its substantial equivalence to other devices, which is a regulatory and functional description rather than a performance evaluation with quantifiable metrics against acceptance criteria.

The information you are asking for, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are characteristic of studies evaluating AI/machine learning medical devices, which this document does not describe.

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