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The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene bearing surfaces.

Indications for Use as a Bipolar

• Femoral head/neck fractures or non-unions,
• Aseptic necrosis of the femoral head,
• Osteo-, theumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
• Pathological conditions or age considerations that indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
• Salvage of failed total hip arthroplasty

Indications for Use as a Total Hip:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

The subject Zirconia-Toughened-Alumina (ZTA) Ceramic Femoral Heads feature:

• Biolox® Delta material: this material is a composite of approximately 75% Alumina ceramic, with the balance consisting of zirconium oxide, chromium oxide, and other oxides,
• A C-Taper bore to mate with C-Taper* stems made from Titanium or CoCr alloys,
• Sizes:
  • 28mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
  • 32mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
  • 36mm diameter with neck lengths of –2.5mm. +0mm. +2.5mm. +5mm.

The provided text is for a 510(k) Summary of Safety and Effectiveness for a medical device (Zirconia-Toughened-Alumina Ceramic Femoral Heads), not an AI/ML device. Therefore, the concepts of acceptance criteria, test set, ground truth, expert adjudication, MRMC studies, or training sets as they relate to AI/ML performance metrics are not applicable to this document.

The document discusses the substantial equivalence of a new device to predicate devices based on:

• Intended Use: The new device shares identical indications for use but has a slightly broader compatibility with hip stems (CoCr or Titanium alloys).
• Design: Same basic design, C-Taper bore, and outer diameters as predicate devices, with neck length options falling within the range of cleared predicate devices.
• Material: Made from ZTA ceramic, similar to one of the cited predicate devices.
• Performance Data: Mechanical testing demonstrated that the new device's mechanical properties were "substantially equivalent" to the predicate devices.

The "acceptance criteria" in this context are implicitly that the new device performs mechanically at least as well as the predicate devices, and that its design, material, and intended use are sufficiently similar to warrant substantial equivalence without requiring new clinical studies. The study proving this involves mechanical testing, not the kind of studies you would conduct for an AI/ML diagnostic device.

Therefore, I cannot fill out the requested table or answer the questions related to AI/ML device performance for this document.

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