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The Preserve 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 Preserve hip stem is intended for cementless hip arthroplasty.

The Preserve stems are short modular hip stems that couple with modular necks. Design features of the stems are summarized below:

• . Cementless stem with proximal cpTi plasma spray coating
• Available in 9 sizes (4-12)
• Manufactured from Ti alloy

The Preserve Hip Stems were evaluated via mechanical testing; including fatigue, fretting; and distraction evaluation. A review of these results indicates that the Preserve Hip Stems are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

Based on the provided text, the document is a 510(k) Summary of Safety and Effectiveness for the PROFEMUR® Preserve Hip Stems, a medical device used in hip replacement surgery. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/algorithm-based medical device.

The document focuses on demonstrating substantial equivalence to predicate devices through:

• Device Description: Material, size, and design features.
• Intended Use and Indications for Use: Identical to previously cleared predicate devices.
• Technological Characteristics: Similar to predicate devices.
• Nonclinical Testing: Mechanical testing (fatigue, fretting, distraction evaluation) per ISO standards.
• Clinical Testing: Explicitly states, "Clinical data was not provided for the class III hip stem."

Therefore, I cannot extract the requested information to fill in the acceptance criteria table or describe a study proving the device meets acceptance criteria as an AI/algorithm.

If this were a submission for an AI-based device, the missing information would be crucial for FDA review. The current document describes a traditional orthopedic implant, where "acceptance criteria" are typically met through engineering testing (like fatigue strength), material compatibility, and demonstrated substantial equivalence to predicate devices, rather than statistical performance metrics of an algorithm.

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