(90 days)
The Partnership Revision Femoral Stems consist of a family of Titanium femoral stems with Titanium plasma spray coating that are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary and revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.
The Partnership Revision Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary and revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth. These femoral components will be made available in two substrate alloys: 1) Ti-6Al-4V, which meets the requirements of ASTM specification F 136; or 2) TMZF alloy (Ti-11.5 Mo-6Zr-2 Fe). The TMZF alloy is the subject of draft ASTM specification F 1813. The Titanium plasma spray coating is CP titanium, which conforms to ASTM specification F 1580.
The provided document is a 510(k) summary for a medical device, specifically the "Partnership Revision Femoral Components" (hip prostheses). While it states that "Testing has demonstrated that the fatigue load carrying capacity of the Partnership Revision Femoral stems exceeds the minimum ISO load requirements," it does not provide explicit acceptance criteria, detailed study results, or the other specific information requested about a device performance study as it relates to software or AI.
The document is primarily a regulatory submission for premarket notification (510(k)) to establish substantial equivalence to existing devices. It focuses on device description, materials, intended use, and substantial equivalence to predicates, rather than on the detailed results of a performance study with acceptance criteria in the manner requested for a modern AI/software device.
Furthermore, the document is from 1997, predating the widespread use of AI in medical devices and the typical methodologies for AI/software device studies. The information requested, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are standard for AI/software device submissions today but are not typically found in 510(k) summaries for mechanical implants from that era.
Therefore,Based on the provided document (K972893 510(k) Summary for Partnership Revision Femoral Components), the detailed information regarding acceptance criteria and a study proving device adherence to these criteria, as typically understood for an AI/software device, is not available.
The document is for a mechanical orthopedic implant (hip prosthesis) from 1997, and its "study" information is limited to demonstrating compliance with mechanical engineering standards rather than clinical performance metrics in the context of AI.
However, I can extract and infer some related information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Minimum ISO load requirements for fatigue load carrying capacity | Exceeds minimum ISO load requirements |
2. Sample size used for the test set and the data provenance: Not applicable/not provided for a clinical performance study in the context of an AI device. The fatigue testing is likely an engineering bench test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Mechanical testing does not typically involve expert ground truth establishment in this manner.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
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 device is a mechanical implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the stated fatigue testing. For a hip prosthesis, the "ground truth" for its function would ultimately be patient outcomes and implant longevity, which is why the FDA required a postmarket surveillance study.
8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
Summary of available information related to performance and post-market study:
- Device Type: Mechanical orthopedic implant (femoral stems for hip arthroplasty).
- Performance Claim: "Testing has demonstrated that the fatigue load carrying capacity of the Partnership Revision Femoral stems exceeds the minimum ISO load requirements."
- Rationale for Postmarket Surveillance (Section 522(a)(1)(C)): Due to the lack of long-term (nine years and greater) clinical safety and effectiveness information for plasma-sprayed porous coatings, particularly regarding potential issues like metal debris, coating spalling, or coating delamination. This indicates that while bench testing met immediate mechanical standards, the long-term biological and clinical performance was an area of concern requiring real-world data.
- Postmarket Surveillance Study Requirements:
- Objective: To monitor for premature failures due to the concerns mentioned above.
- Duration: Over a nine-year period.
- Sample Size (Anticipated): "Several hundred patients" in whom the device was implanted.
- Endpoints: Actuarial survivorship analysis (proportion of hips revised), patient self-assessment of function, patient deaths, losses to follow-up.
- Data Collection: Stratification by revision of acetabular/femoral components, baseline variables (device configuration, diagnosis, pre-implantation Harris Hip Score).
- Purpose: To act as an early warning system for late-occurring effectiveness and safety problems.
In conclusion, the document details a mechanical performance test (fatigue load carrying capacity) which the device passed against ISO requirements. However, it does not provide detailed metrics or performance data for that test within the 510(k) summary. Significantly, the FDA mandated a post-market surveillance study precisely because a clinical long-term performance study with sufficient sample size and duration regarding the plasma-spray coating was lacking at the time of clearance. The criteria and methodology for this post-market study are outlined but represent future data collection rather than pre-market proof.
§ 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.