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The PROFEMUR® LX Revision 5/8 Coated 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:

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

The PROFEMUR® L.X Revision 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.

The design features of the PROFEMUR® LX Revision 5/8 Coated Hip Stem are summarized below:

• Manufactured from titanium alloy (Ti6Al4V) .
• Proximal 5/8 of stem plasma sprayed .
• Offered in Sizes 13-21
• Polished distal tip and collar
• Threaded hole with slot impaction mechanism

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it is a 510(k) summary for a hip stem device, focusing on its intended use, design features, and substantial equivalence to previously cleared predicate devices.

The document states: "The safety and effectiveness of the PROFEMUR® LX Revision 5/8 Coated Hip Stem is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."

However, it does not explicitly detail:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for certain medical devices, rather than presenting a performance study with detailed acceptance criteria and results for the PROFEMUR® LX Revision 5/8 Coated Hip Stem itself.

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