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The Zimmer Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

The Zimmer Zirconia Ceramic Femoral Head is made from yttria stabilized zirconia oxide (ZrO2) ceramic and provides an alternative to cobalt-chrome alloy, and aluminum oxide ceramic femoral heads. The Zimmer Zirconia Ceramic Femoral Head is intended for mating with either a Tivanium® Ti-6Al-4V Alloy or Zimaloy® Cobalt-Chrome-Molybdenum Alloy modular femoral stem equipped with a tapered neck of identical dimensions. The Zimmer Zirconia Ceramic Femoral Head is designed to articulate upon the UHMWPE-bearing surface of an acetabular component. The prosthesis is supplied in 22, 26, and 28 mm diameters and a variety of neck lengths.

This document is a "Summary of Safety and Effectiveness" for the Zimmer® Zirconia Ceramic Femoral Head. It is a regulatory submission, not a study report demonstrating acceptance criteria based on performance data. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, or study designs like MRMC or standalone performance.

The document does provide the following minimal information that broadly relates to your request, but cannot fill out the requested table or answer the specific questions:

• Device Description and Intended Use: This outlines what the device is and what it's for, implicitly defining its "purpose" but not setting specific performance thresholds.
• Comparison to Predicate Devices: This section highlights the device's substantial equivalence to existing devices, implying that if the predicates are safe and effective, this device should also be. However, it doesn't provide performance metrics to prove this.
• "Clinical and Nonclinical Data" (Statement on zirconia ceramic):
  • It mentions that "Ceramic materials have been successfully used in orthopaedic applications for approximately 20 years," suggesting a general acceptance of the material class.
  • It notes that the yttria stabilized zirconium oxide has "limited clinical history."
  • It also states that "mechanical testing demonstrates that when used with polyethylene acetabular cups, the zirconia ceramic femoral head produces a relatively low amount of particulates," but immediately qualifies this by saying "the total amount of particulate produced remains undetermined" and "the long-term biological effects of these particulates are unknown."
  • Crucially, it says: "Clinical investigation of the zirconium oxide ceramic prosthesis is ongoing." This indicates that a comprehensive study proving safety and effectiveness (and thus meeting acceptance criteria) was not complete at the time of this submission.

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