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The Avanta Orthopaedics Trapezial Implant is a device intended to be used in the treatment of thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepation during circumduction movements with axial compression of the thumb. Loss of thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint of the thumb or thumb and index finger in combination. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity.

The Avanta Orthopaedics Trapezial Implant is a device intended to be implanted in the trapezial bone of the wrist. It is made of molded silicone elastomer.

Given the limitations of the provided text, which is a 510(k) summary for a medical device and not a study report, it is not possible to provide the requested information about acceptance criteria and a study proving device performance.

The provided text only describes the device, its intended use, and its predicate device. It does not contain any information regarding clinical studies, performance data, acceptance criteria, ground truth, sample sizes, or expert involvement.

Therefore, I cannot populate the table or answer the specific questions. This 510(k) summary serves as a regulatory filing and not a detailed clinical study report. To obtain the requested information, one would need access to the full 510(k) submission, supporting clinical data, or published studies related to the Avanta Orthopaedics Trapezial Implant.

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