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The Fiber Metal Taper Hip Prosthesis is a femoral stem designed for implantation into the human femur in either total hip or hemi-hip replacement and is indicated for the following:

Total Hip Replacement: Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-Hip Replacement: Fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged: nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The Fiber Metal Taper Hip Prosthesis is a collarless, modular femoral stem manufactured from Tivanium® Ti-6Al-4V Alloy. The modular connection of the femoral stem is a Morse-type 12/14 proximal neck taper designed to mate with the corresponding 12/14 bore of a femoral head component. The proximal body of the stem features a trapezoidal geometry. The Fiber Metal Taper Hip Prosthesis will be available in nine sizes (10 through 18) with size increments of 1 mm. Stem sizes 12 through 16 mm are designed with two proximal body options, standard and large metaphysis. A commercially pure titanium circumferential fiber metal pad is metallurgically bonded to the proximal one-third of the stem. The surface of the midstem region features a roughened surface providing for bone ongrowth and implant fixation. The distal shaft is tapered in both the medial/lateral plane and the anterior/posterior plane.

The provided text describes the Zimmer Biomet VerSys™ Hip System—Fiber Metal Taper Hip Prosthesis, a femoral hip prosthesis. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text. The document is a "Summary of Safety and Effectiveness" which focuses on device description, intended use, and comparison to predicate devices, but lacks the specific clinical study data needed to answer the prompt thoroughly.

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