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The Ascension® PyroSphere® is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

The Ascension PyroSphere (PCS) is a single-use, spherical, interpositional prosthesis for the basal thumb joint. It is fabricated from a thick pyrocarbon layer encasing a graphites core that is impregnated with one-atomic percent tungsten so it is radiopaque. The device is avoilable in five sizes and is provided sterile in packaging containing a single component.

The provided text is a 510(k) summary for the Ascension® PyroSphere® CMC implant, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) summary focuses on establishing substantial equivalence to predicate devices based on design features and performance tests. It outlines the device description, intended use, and substantial equivalence to previously approved devices (Ceramic Zirconia Spherical CMC Implant (K960659) and Ascension PyroHemiSphere (K041451)).

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and a study to prove its performance against those criteria, as this information is not present in the provided document.

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