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The DePuy ASR™ Resurfacing Femoral Heads are intended for cemented use in hemiarthroplasty (partial hip replacement procedure). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acctabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

The DePuy ASR™ Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a onepiece cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm to suit varying patient anatomy.

The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the ninimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum.

This submission (K032659) does not contain information about studies with acceptance criteria or device performance data. It is a 510(k) summary for the DePuy ASR™ Resurfacing Femoral Heads, focusing on substantial equivalence to predicate devices.

The document states that DePuy considers the ASR™ Resurfacing Femoral Heads to be substantially equivalent to previously marketed devices (DePuy T.A.R.A. Total Hip, Biomet Cemented Femoral Resurfacing Head device) based on "mechanical properties, material composition, and intended use."

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This 510(k) submission primarily establishes substantial equivalence based on prior device characteristics and does not present new performance study data against defined acceptance criteria.

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