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The PROFEMUR® GLADIATOR® HA Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use:

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

The PROFEMUR® Gladiator HA Hip Stem is intended for cementless hip arthroplasty.

The PROFEMUR® GLADIATOR® HA stems are hydroxyapatite coated hip stems that couple with modular necks. Design features of the stems are summarized below:

• Cementless stem with hydroxyapatite plasma spray coating
• Available in 10 sizes
• Manufactured from Ti alloy (Ti-6Al-4V) conforming to ASTM F620
• Hydroxyapatite coating conforming to ASTM F1185
• Available with and without collar

I am sorry, but based on the provided text, there is no information about an AI/ML device, its acceptance criteria, or a study proving that it meets those criteria. The document describes the PROFEMUR® GLADIATOR® HA Hip Stems, which are a mechanical medical device (a hip implant). The evaluation for this device was based on mechanical testing (fatigue, fretting, and distraction evaluation) and a comparison to predicate devices, not on AI/ML performance metrics.

Therefore, I cannot provide a response to the requested subsections as they pertain to AI/ML device evaluation, which is not present in the given text.

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