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The Ascension® Silicone MCP is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative, or traumatic arthritis.

The Ascension Silicone MCP is an anatomically designed, single-use, one-component hinged prosthesis designed to be implanted without hone cement across the metacarpophalangeal joint. It is made from flexible, injection-molded, medical grade silicone elastomer. The proximal and distal stems of the Ascension Silicone MCP are pre-flexed at 30° to match the approximate natural 30° flexion stance of the relaxed human hand.

The provided text is a 510(k) summary for the Ascension® Silicone MCP finger joint implant. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance, a study proving the device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

The document explicitly states: "Performance tests and analyses demonstrate that the Ascension® Silicone MCP is substantially equivalent to the predicate device." This indicates that some form of performance assessment was conducted, but the details of these tests, specific acceptance criteria, or the results are not included in this summary.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided text. The information required to answer these questions (acceptance criteria, reported performance, study details, etc.) is not present in the given 510(k) summary.

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