(923 days)
The MAYO Hip is used in total hip arthroplasty, a surgical procedure restricted to patients with substantial pain or marked functional disabilities in which conservative treatment has not provided acceptable relief and who are not candidates for other less aggressive forms of surgery. This hip is indicated for noncemented use in skeletally mature individuals. Diagnostic indications include severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The MAYO Hip Prosthesis is a short-stemmed, press-fit modular femoral component developed by Bernard F. Morrey, M.D., of the Mayo Clinic and is intended to be implanted into the human femur to replace a hip joint. The MAYO Hip incorporates several technological features of the Zimmer Anatomic Hip Prosthesis (and other predicate devices) such as the Morse-type tapered neck and fiber metal pads for bone ingrowth, and is made from the same materials (titanium alloy and commercially pure titanium) as the predicate devices. The femoral stem is collarless, has a dual taper (double wedge) body, and has a short distal stem (tail). The femoral stem is available in four sizes each of which can be utilized in the left or right hip.
The modular femoral stem is designed to mate with a femoral head through a Morse-type taper. The femoral head in turn articulates upon the UHMWPE liner of an acetabular component. The MAYO Hip Prosthesis meets the criteria of the generic device described in 21 CFR 888.3358.
The MAYO Hip supports a conservative approach to total hip arthroplasty by allowing for minimal femoral neck resection, minimal bone preparation, minimal stress shielding, absence of intramedullary fixation, reduction in blood loss, and potential for ease of revision.
The short distal portion of the stem is used to assist in proper placement of the stem and provides for rotary fixation. Immediate fixation is achieved through three-point (anteroposterior and lateral planes) fixation in the metaphyseal bone of the proximal femur. The stem does not rely upon intramedullary fixation, therefore the source of thigh pain is eliminated. Surgery time is reduced because the femoral medullary canal is not reamed or violated. This results in statistically significant less blood loss than that of a conventional, uncemented primary total hip arthroplasty. Additionally, reduction in the amount of metal (due to the short distal stem and double wedge shape) results in less exposure of a foreign body to the intramedullary canal. The conservative femoral neck resection, which preserves bone stock, will facilitate subsequent procedures should a revision of the hip be required.
This document describes the safety and effectiveness of the MAYO® Hip Prosthesis. However, it does not contain the specific information required to complete the detailed table and answer the study-related questions. The provided text is a summary of safety and effectiveness, likely from a regulatory submission, which discusses the device description, intended use, comparison to predicate devices, and mentions clinical and nonclinical data in a general way, but does not provide the granular details of a specific clinical study with acceptance criteria and performance metrics.
Specifically, the following information is missing from the provided text:
- Explicit Acceptance Criteria: The document mentions "satisfactory clinical outcome" and "statistically significant reduction in blood loss" and "pain," but it does not specify quantitative acceptance criteria (e.g., "95% survival rate at 5 years," "mean blood loss reduction of X ml").
- Reported Device Performance against specific criteria: While general positive outcomes are noted, specific performance metrics against defined acceptance criteria are absent.
- Details of the "eight years of clinical research": This is a key piece of information that is only mentioned generally.
- Sample size used for the test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
- Number of experts and qualifications for ground truth: Not specified.
- Adjudication method: Not specified.
- MRMC comparative effectiveness study details: Not specified. It mentions a comparison of blood loss and pain reduction between MAYO Hip and BIAS Hip, but this isn't framed as an MRMC study with human readers improving with AI.
- Standalone performance: Not applicable as this is a medical device, not an AI algorithm.
- Type of ground truth used: Implied clinical outcomes (pain, blood loss, satisfactory outcome), but not explicitly defined in terms of how it was established (e.g., expert consensus, pathology, long-term follow-up).
- Sample size for the training set: Not applicable, as this is a physical medical device, not an AI model.
- How ground truth for training set was established: Not applicable.
Therefore, while the document confirms that performance data exists and supports claims of safety and effectiveness, it does not provide the detailed study design, acceptance criteria, and specific performance results that you are requesting in your template.
§ 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.