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The PROFEMUR® S Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and,
• revision procedures where other treatments or devices have failed

The design features of the PROFEMUR® S Hip Stem are summarized below:

• Offered in two medial flare options .
• Modular neck taper .
• Triplanar proximal geometry w/ plasma spray .
• Splined, slotted, and cylindrical distal stem w/ grit blast .
• Dimple with cross slot on lateral shoulder ●
• Polished distal tip and collar .

The provided text does not contain any information regarding specific acceptance criteria or a study that evaluates the performance of the PROFEMUR® S Hip Stem against such criteria.

The document is a 510(k) Summary of Safety and Effectiveness for the PROFEMUR® S Hip Stem, which is focused on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, rather than providing a performance study with specific acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on:

• Intended Use: What the device is designed for.
• Device Description: Its features.
• Substantial Equivalence Information: Comparing it to existing devices to show it's fundamentally similar in design, materials, and technology.

There is no mention of a performance study, acceptance criteria, sample sizes, expert review, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for any test or training sets.

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