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The PROFEMUR® TL 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, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
• correction of functional deformity; and, 3.
• revision procedures where other treatments or devices have failed 4.

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

• Wrought or forged titanium alloy (ASTM F136 or F620) .
• Body shape is a flat tapered wedge .
• Cross-section is rectangular with radiussed medial and lateral sides .
• Size range 1-12 .
• Glass bead surface finish, with proximal plasma spray coating .
• Neck taper for use with modular necks .
• Dimple and cross slot impaction mechanism .

This is a 510(k) premarket notification for a medical device called the PROFEMUR® TL Hip Stem, a hip implant. The document states that the device is substantially equivalent to predicate devices, and therefore does not require the extensive clinical trials and performance studies typical of novel medical AI devices.

As such, none of the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details) are present in the provided text. The document focuses on demonstrating substantial equivalence to existing devices rather than presenting novel performance data.

The FDA's letter (pages 2-3) confirms the "substantial equivalence determination" to a "legally marketed predicate device," which is a regulatory pathway that bypasses the need for new clinical effectiveness data if the device is similar enough to one already on the market.

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