Search Results

The PROFEMUR® XTR Cemented 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 joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed.

The design features of the PROFEMUR® XTR Cementcd Hip Stem are summarized bclow:

• The PROFEMUR® XTR Ccmented Hip Stem is available in 5 sizes and is intended for use with previously cleared WMT modular necks.
• The PROFEMUR® XTR Cemented Hip Stem features a dual tapering stem and polished surface.
• The PROFEMUR® XTR Ccmented Hip Stem is intended for cemented use only.

This document is a 510(k) summary for the PROFEMUR® XTR Cemented Hip Stem, dated January 19, 2006. It details the device's intended use and describes its features. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a diagnostic AI/ML device submission would.

The document focuses on demonstrating substantial equivalence to previously cleared devices. This means that instead of presenting a study with specific performance metrics against acceptance criteria, the submission asserts that the new device is as safe and effective as a predicate device already on the market because it shares similar technological characteristics and intended use.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them based on the provided text. The submission type (510(k) for a hip stem) does not typically require the detailed statistical performance analysis against predefined acceptance criteria that would be expected for a diagnostic AI/ML device.

Here's what I can infer from the document about its regulatory pathway, which differs significantly from a performance study:

• Regulatory Pathway: The device is cleared via a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a predicate device, rather than requiring new clinical trials that establish acceptance criteria and then prove they are met.
• Proof of Safety and Effectiveness: "The safety and effectiveness of the PROFEMUR® XTR Cemented Hip Stem are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." (Page 1). This indicates that the "testing results" are likely bench testing (material, mechanical) to ensure the device performs as expected structurally, not a clinical study measuring diagnostic accuracy or clinical outcomes against specific statistical endpoints.
• No Clinical Study Details: There is no mention of patient cohorts, ground truth establishment, expert readers, sample sizes for test or training sets, adjudication methods, or MRMC studies, all of which would be present in a submission for a diagnostic AI/ML device.

In summary, the provided document does not contain the information requested because the regulatory approval pathway for this type of medical device (a cemented hip stem) in 2006 focused on substantial equivalence rather than a detailed performance study with acceptance criteria as typically found in submissions for AI/ML diagnostic tools.

Ask a specific question about this device