(219 days)
The Metal on Metal Acetabular System is indic. ted for used in patients requiring total hip replacement due to the following:
- a.) Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, leg perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, and traumatic arthritis
- b.) Rheumatoid arthritis
- c.) Correction of functional deformity
- d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- e.) Revision of previously failed total hip arthroplasty.
The Metal on Metal Acetabular System consists of a titanium outer shell with a cobalt chromium metallic liner, which articulates with a cobalt chromium modular head. Based on mechanical testing, it has been shown that the Metal on Metal Acetabular System exhibits decreased wear compared to the wear observed in the traditional polyethylene and metal acetabular systems.
This document is a 510(k) summary for a medical device (Metal on Metal Acetabular System) seeking substantial equivalence to existing devices. It does not describe a study to prove acceptance criteria or device performance in the way a clinical trial or performance study would for an AI/ML powered device. Instead, it focuses on describing the device, its intended use, and comparing it to predicate devices to demonstrate substantial equivalence for regulatory approval.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available within this document because it describes a mechanical device, not an AI/ML powered medical device.
The document highlights the device's design, materials, and mechanical properties. The "acceptance criteria" in this context would likely refer to regulatory standards for mechanical device performance (e.g., wear, strength, biocompatibility), which are typically demonstrated through engineering tests and material specifications, rather than clinical studies with human readers or AI algorithms.
Summary of available information (and lack thereof for AI/ML specific questions):
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): The document implies acceptance criteria related to mechanical properties and wear performance, as it states: "Based on mechanical testing, it has been shown that the Metal on Metal Acetabular System exhibits decreased wear compared to the wear observed in the traditional polyethylene and metal acetabular systems." Specific numerical acceptance criteria are not provided.
- Reported Device Performance:
- Wear: "decreased wear compared to the wear observed in the traditional polyethylene and metal acetabular systems." (No specific quantitative wear rates are mentioned for the new device itself, only a comparative statement).
- Liner Sphericity: Average Peak to Valley deviation of 59.8024 micro-inches. This is stated to be "less than half the allowable deviation set forth in the ISO standard for modular head sphericity." (This is a performance metric against an implied ISO standard acceptance criterion).
- Liner Surface Roughness: Articulating surface averages 0.17 micro-inches Rₐ.
- Modular Head Surface Roughness: Articulating surface is 0.43 micro-inches. Bore surface roughness is 34 micro-inches.
2. Sample size used for the test set and the data provenance: Not applicable. This is for a mechanical device; there's no "test set" in the context of an AI/ML study. Performance is evaluated through mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to a mechanical device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. "Ground truth" for this device would be established by engineering specifications, material properties, and mechanical test results (e.g., measuring wear rates in a lab, verifying dimensions against blueprints).
8. The sample size for the training set: Not applicable. There is no training set for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.