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For treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal.

The modification to the system consists of a change in the method or porous coating of the acetabular shells from a two layer process to a three layer process utilizing a smaller bead size and smaller pore size.

The provided text is related to a 510(k) premarket notification for a medical device called the "Foundation (FMP) Acetabular Cup". This document is a regulatory approval, not a scientific study report describing acceptance criteria and device performance based on a study.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.

The document states: "The modification to the system consists of a change in the method or porous Description: coating of the acetabular shells from a two-layer process to a three-layer process utilizing a smaller bead size and smaller pore size." and "Features comparable to predicate devices include the same materials, design, indications, packaging, labeling, and sterilization."

The approval is based on substantial equivalence to predicate devices, not on a new clinical study with specific performance metrics against acceptance criteria.

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