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Joint replacement is indicated for patients suffering from disability due to:

• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
• rheumatoid arthritis;
• correction of functional deformity;
• femoral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts.

This device is to be used for uncemented applications.

This Traditional 510(k) is a line extension to the X-alt Highly Cross Linked Acetabular Liner with Vitamin E product line to expand femoral head compatibility within the system by making larger femoral heads compatible with smaller acetabular cups.

The provided text describes a medical device called "FMP Extended Liners" for hip joint replacement. However, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

• Acceptance Criteria and Device Performance (Question 1): The document states "All evaluations determined that the devices are substantially equivalent to the applicable predicate devices" after listing non-clinical tests (wear, impingement, push-out, lever-out, torsion, range of motion). This indicates that the device met the performance standards demonstrated by the predicate devices. However, the specific acceptance criteria (e.g., "wear not to exceed X mm^3/million cycles") and the reported device performance values for each test are not provided.

• Sample Size, Ground Truth, Adjudication, MRMC, Standalone, Training Set (Questions 2-9): The document explicitly states: "Clinical Testing: Clinical testing is not required." This means that no human-based studies (like those involving test sets, ground truth establishment, expert adjudication, or MRMC studies) were conducted or reported for this submission. The tests performed were non-clinical (mechanical and material tests). Similarly, there is no mention of a training set or how ground truth for a training set would be established, as algorithm-only performance (standalone) studies typically apply to software or AI/ML devices, not mechanical implants.

In summary, based on the provided text, I cannot answer questions 1-9 comprehensively because the submission focuses on demonstrating substantial equivalence through non-clinical laboratory testing, rather than clinical trials or AI/ML performance studies with specific acceptance criteria and performance metrics for such studies.

The information available is:

• Device Name: FMPT™ Extended Liners
• Tests Performed: Wear per ISO 14242-2/3, impingement per ASTM F2582-14, push-out, lever-out, torsion per ASTM F1820-13, and range of motion per ISO 21535:2009.
• Conclusion of Tests: "All evaluations determined that the devices are substantially equivalent to the applicable predicate devices."
• Clinical Testing: Not required.

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