(52 days)
The MAYO 12/14 Conservative Hip Prosthesis is indicated for cementless use in skeletally mature individuals undergoing primary surgery for total hip replacement. Diagnostic indications include severe hip pain and disabilities due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Like the predicate MAYO Hip, the MAYO 12/14 Hip Prosthesis is a modular femoral stem intended to replace the hip joint in total hip arthroplasty. It is used with a variety of modular femoral heads. The stem is collarless, wedge-shaped, and is intended for use without bone cement. Fixation is achieved by biological ingrowth into the fiber metal pads and by mechanical press fit into the proximal femoral shaft.
The provided text is a "Summary of Safety and Effectiveness" for the MAYO® Conservative Hip Prosthesis. It details the device's description, intended use, and comparison to predicate devices. However, the document states: "Non-clinical performance testing demonstrated that the device is equivalent to the predicate."
This statement indicates that the regulatory submission relied on non-clinical performance data to show equivalence to a predicate device, rather than a clinical study with specific acceptance criteria and detailed device performance metrics relevant to an AI/Software as a Medical Device (SaMD).
Therefore, based on the provided text, I cannot extract the information required for your request, as it pertains to AI/SaMD performance studies. There is no mention of:
- Acceptance criteria tables with reported device performance for an AI/SaMD.
- Sample sizes, data provenance, or ground truth for test or training sets for an AI/SaMD.
- Expert involvement (number, qualifications, adjudication methods) for establishing AI/SaMD ground truth.
- MRMC comparative effectiveness studies or standalone AI performance.
The document describes a traditional medical device (hip prosthesis) and its regulatory clearance process, which focuses on demonstrating equivalence to existing devices through manufacturing processes, materials, and non-clinical testing, rather than AI model performance.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.