(79 days)
The 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 Zirconia Ceramic Femoral Head (12/14 taper) is made from yttria stabilized zirconium oxide (ZrO2) ceramic and provides an alternative to cobalt-chrome alloy femoral heads. The 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 Zirconia Ceramic Femoral Head is designed to articulate upon the UHMWPE-bearing surface of an acetabular component. The prosthesis is supplied in 26, 28, and 32 mm diameters and a variety of neck lengths.
The provided document is a 510(k) summary for a medical device, the Zirconia Ceramic Femoral Head (12/14 Taper). It outlines the device's description, intended use, and comparison to predicate devices, but does not contain any information about acceptance criteria or specific studies proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or similar measures typically associated with AI/software devices.
This document describes a physical implantable medical device and its substantial equivalence to existing predicate devices based on material, design, and intended use, rather than a diagnostic or AI-powered device that would typically have acceptance criteria presented in the requested format.
Therefore, I cannot provide the requested information from the provided text. To clarify:
- No acceptance criteria (e.g., sensitivity, specificity, workflow metrics) are mentioned. The document focuses on regulatory clearance through substantial equivalence.
- No "study" in the sense of a clinical trial or performance evaluation with a test set, ground truth, or expert readers is described. The "Clinical and Nonclinical Data" section merely states that "The yttria stabilized zirconium oxide from which the Zirconia Ceramic Femoral Head is made has a limited clinical history" and that "Clinical investigation of the zirconium oxide ceramic prosthesis is ongoing." This indicates a lack of completed, reported studies, not the description of one.
- No information on sample size (for test or training sets), data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance is present.
- The "ground truth" referenced in the document relates to the long-term biological effects of particulates, which are stated as "unknown" at the time of submission. This is not a ground truth for evaluating device performance in the context of the prompt.
Essentially, this document is a regulatory submission demonstrating substantial equivalence for a physical medical device, not a performance study for an AI or software device.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.