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Biolox ceramic heads and Foundation™ Forged, Textured and Porous Stems are intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck 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.

Biolox ceramic heads for use with Foundation™ Forged, Textured and Porous Stems that were cleared for commercial distribution in K952191, K935263 and K952297, respectively.

This document does not describe a medical device that uses AI or machine learning, nor does it provide information about a study involving performance metrics, sample sizes, ground truth establishment, or expert evaluations.

The document is a "Summary of Safety and Effectiveness" for a physical medical device: "Biolox ceramic heads for use with Foundation™ Forged, Textured and Porous Stems." It describes the device, its intended use, and its comparability to predicate devices.

Therefore, I cannot extract the requested information such as acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as this information is not present in the provided text.

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