(188 days)
Femoral heads are single-use devices that are mated via a press-fit tapered neck with titanium or cobalt-chrome alloy femoral stems in total and hemi-hip arthroplasty procedures.
The design of the femoral heads includes a spherical head portion that is highly polished and processed with the Co-Nidium surface treatment. Femoral heads for total hip arthroplasty procedures are available in diameters from 22 to 32 mm with varying neck lengths. Femoral heads for hemi-hip arthroplasty procedures are available in 38 to 63 mm outer diameters. The femoral heads include a tapered portion that fits securely onto a modular femoral stem component.
The provided text describes a medical device, "Cobalt-Chromium-Molybdenum Alloy Femoral Heads with Co-Nidium™ Surface Hardening Process," and its performance data, but it does not contain explicit acceptance criteria or a study designed to directly prove the device meets such criteria.
The document primarily focuses on a "Summary of Safety and Effectiveness" for a 510(k) submission, which involves demonstrating substantial equivalence to predicate devices rather than proving compliance with pre-defined acceptance criteria through a specific study.
However, based on the "Performance Data" section, we can infer some implied "acceptance criteria" related to device performance in comparison to predicate devices. Below is an attempt to structure this information, acknowledging that the format of the request doesn't perfectly align with the provided content.
Acceptance Criteria and Reported Device Performance (Inferred)
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance |
|---|---|
| Improved abrasive wear resistance compared to predicate device. | Demonstrated improved abrasive wear resistance when compared to the predicate device. |
| No change in breakdown potential of alloy material due to surface hardening during corrosion testing. | Corrosion testing demonstrated that the breakdown potential of the alloy material is not changed by surface hardening. |
| Higher fatigue strength compared to currently marketed devices (predicate). | Fatigue testing indicated that the fatigue strength of the nitrided alloy is higher than the fatigue strength of currently marketed devices. |
| No change in dimensional analysis for nitrided femoral heads. | Dimensional analysis showed no change for the nitrided femoral heads. |
| No change in coefficient of friction data for nitrided femoral heads. | Coefficient of friction data showed no change for the nitrided femoral heads. |
| Higher microhardness compared to predicate device. | Microhardness exhibited higher hardness when compared to the predicate device. |
| Higher depth of hardening compared to predicate device. | ESCA data exhibited higher depth of hardening when compared to the predicate device. |
Study Information (Based on provided text)
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Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for any of the tests (wear, corrosion, fatigue, dimensional analysis, coefficient of friction, microhardness, ESCA).
- The data provenance is not explicitly stated (e.g., country of origin), nor is it specified if the tests were retrospective or prospective. These are lab-based tests on engineering properties rather than clinical studies on patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The concept of "ground truth" established by experts, as typically seen in AI or diagnostic studies, is not applicable here. The "ground truth" for the performance data in this document is derived from direct engineering measurements and material analysis methods (e.g., wear rate, fatigue strength values, microhardness readings).
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Adjudication method for the test set:
- Adjudication methods (like 2+1, 3+1) are for interpreting qualitative data or disagreements among experts. This is not applicable to the quantitative engineering tests described. The results are objective measurements from laboratory equipment.
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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:
- No. This is a submission for a medical device (femoral head), not an AI or diagnostic imaging device. An MRMC study is completely irrelevant to this type of product.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This refers to the performance of an algorithm. This document describes the physical and material properties of a hip implant component.
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The type of ground truth used:
- The "ground truth" for the performance data presented is derived from objective engineering measurements and material science analysis obtained through standardized laboratory testing procedures. For example, "wear testing" would involve measuring material loss, and "fatigue testing" would involve measuring cycles to failure under specific load conditions. The "ground truth" stems from the direct results of these physical and chemical tests.
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The sample size for the training set:
- The concept of a "training set" is not applicable here. This document describes physical device performance, not an AI model.
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How the ground truth for the training set was established:
- Not applicable, as no training set is involved.
In summary: The provided text is a regulatory submission for a physical medical device. It describes various engineering tests to demonstrate the device's performance characteristics in comparison to existing predicate devices. It does not follow the structure of an AI/diagnostic study, and therefore many of the requested points related to "acceptance criteria," "ground truth," "experts," "sample sizes" for test/training sets, and "AI performance" are not directly present or applicable in the provided context.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.