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VerSys Cemented Revision/Calcar is indicated for total hip arthroplasty in patients: Whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.

The VerSys CRC Hip System includes femoral stems and build-up blocks that are permanent hip implants and provided sterile via gamma irradiation. The VerSys CRC Hip System include femoral stems in a variety of body sizes and lengths and build-up blocks in heights of 10mm, 20mm, and 30mm. The block is attached to the femoral stem by inserting two Tivanium® Ti-6Al-4V alloy screws into the holes provided. Only one build-up block can be attached to a femoral stem The modular connection of the femoral stem is a Morse-type 12/14 taper designed to mate with the corresponding bore of a femoral head.

This is a medical device 510(k) premarket notification and does not contain information on the acceptance criteria and study design for an AI/ML device. The document primarily focuses on demonstrating substantial equivalence of a hip prosthesis (VerSys Cemented Revision/Calcar Hip System) to a legally marketed predicate device through non-clinical performance testing.

Therefore, the requested information regarding acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided text.

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