(78 days)
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis. The device is a single use implant intended for press-fit application.
The Press-Fit Head Resurfacing device is designed to replace the outer surface of the femoral head while preserving as much natural bone as possible. The device retains the diameter of the natural femoral head and articulates aqainst the natural acetabulum (hemi-hip). The device is manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75. It has a highly polished outer surface and a titanium plasma spray coated inner surface. A central post is provided for stabilization. The device is available in diameters of 38mm to 60mm, in one-millimeter increments.
The provided document is a 510(k) premarket notification for a medical device, the "Press-Fit Head Resurfacing Device." It does not present any clinical study data or acceptance criteria related to device performance.
Based on the content of the document, the following observations can be made relevant to your request:
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Table of acceptance criteria and reported device performance:
- Not Applicable: The document explicitly states "Non-Clinical and Clinical Testing: None provided." This indicates that no performance data from such studies, nor specific acceptance criteria, are included or were required for this 510(k) submission.
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Sample size used for the test set and the data provenance:
- Not Applicable: As no clinical or non-clinical testing data is provided, there is no test set or associated sample size discussed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: No clinical or non-clinical testing was provided, so no ground truth establishment by experts is mentioned.
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Adjudication method for the test set:
- Not Applicable: No clinical or non-clinical testing was provided, so 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 Applicable: This device is a physical implant (a hemi-hip prosthesis), not an AI-powered diagnostic or imaging device. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable: This device is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable: No clinical or non-clinical testing was provided, so no ground truth is discussed.
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The sample size for the training set:
- Not Applicable: There is no mention of a training set as no machine learning or AI component is involved.
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How the ground truth for the training set was established:
- Not Applicable: No training set or associated ground truth establishment is mentioned.
Summary of Safety and Effectiveness from the Document:
The document states one "Summary of Safety and Effectiveness." The basis for substantial equivalence is primarily on material and design similarities, not on performance data from primary studies.
"The materials, surface finishes and processing of the Press-Fit Head Resurfacing Device are similar to the predicate device."
This 510(k) submission relies on demonstrating substantial equivalence to already legally marketed devices based on technological characteristics and intended use, rather than presenting novel clinical performance data. The FDA's decision to clear the device (K023188) was based on this substantial equivalence to predicate devices (K021799, K811008, K962514, K811718), and not on a new study demonstrating its performance against specific acceptance criteria.
§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing 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 resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.