(42 days)
The PLUS Fracture Head Prosthesis is intended for use in fractures of the femoral neck and fractures or avascular necrosis of the femoral head with all PLUS hip stem prostheses, which have the appropriate 12/14 Morse Taper.
The PLUS Fracture Head Prosthesis comes in 12 different sizes and in two neck lengths. The PLUS Fracture Head Prosthesis is made of CoCrMo and its highly polished metal surface minimizes friction between the implant and the acetabulum. The standard cone allows various possible combinations with all PLUS hip stems. This makes it possible to obtain better stress distribution, which can reduce wear on the acetabulum and pain for the patient. The PLUS Fracture Head Prosthesis can be changed into a total hip prosthesis without replacing the femoral components.
The provided text is a 510(k) Summary for the PLUS Fracture Head Prosthesis, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Crucially, a 510(k) Summary, especially for a device like a prosthesis, does not typically contain information about "acceptance criteria" or detailed "study data" in the way one might expect for a diagnostic or AI-driven device. The emphasis is on demonstrating equivalence based on design, materials, and intended use, often supported by comparisons to predicate devices and well-established engineering principles (e.g., material testing for strength or biocompatibility, if applicable). Clinical performance studies with defined acceptance criteria and specific numerical outcomes are rare for 510(k) submissions of this nature unless there's a novel feature or indication requiring such data.
Based on the provided text, the answer is that the document explicitly states "None provided at this time. Performance data:". Therefore, the following information cannot be extracted from the given input.
However, to address your request in the context of what would be expected if such data were present, I will outline what each point would entail if this were a study on an AI/diagnostic device, and explicitly state that the information is not found in the provided text.
Summary of Acceptance Criteria and Device Performance (Not Found in Document)
| Metric | Acceptance Criteria (Not Provided) | Reported Device Performance (Not Provided) |
|---|---|---|
| [Example: Sensitivity] | [e.g., > 90%] | [e.g., N/A - no performance data reported] |
| [Example: Specificity] | [e.g., > 85%] | [e.g., N/A - no performance data reported] |
| [Example: Accuracy] | [e.g., > 92%] | [e.g., N/A - no performance data reported] |
| [Example: Other metric] | [e.g., Precision, F1-score] | [e.g., N/A - no performance data reported] |
Explanation for Absence of Data:
The provided document explicitly states under the "Performance data" section: "None provided at this time." This indicates that the 510(k) submission for the PLUS Fracture Head Prosthesis did not include a study with acceptance criteria and measured device performance that would fall under the categories typically associated with AI or diagnostic device evaluation. For a hip prosthesis, the FDA clearance via a 510(k) often relies on substantial equivalence regarding materials, design, mechanical properties, and biocompatibility to a predicate device, rather than clinical performance studies with numerical acceptance criteria.
Further Specific Details (Not Found in Document):
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Sample size used for the test set and the data provenance:
- Not Found. The document does not mention any test set, sample size, or data provenance (country, retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Found. No ground truth establishment is mentioned, as there is no reported performance study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Found. No adjudication method is mentioned.
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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:
- Not Found. This type of study (MRMC for AI assistance) is not relevant to a hip prosthesis and is not mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Found. This is not applicable to a hip prosthesis and no such study is mentioned.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Found. No ground truth is mentioned.
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The sample size for the training set:
- Not Found. No training set is mentioned.
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How the ground truth for the training set was established:
- Not Found. No training set or ground truth establishment is mentioned.
Conclusion:
The provided 510(k) Summary for the PLUS Fracture Head Prosthesis explicitly states "None provided at this time. Performance data:". Therefore, no information regarding acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment is available in the document. The clearance of this device would have relied on demonstrating substantial equivalence to a predicate device through other means, typically involving engineering safety and material specifications.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.