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FOR HEMI-HIP RESURFACING ARTHROPLASTY:

The Durom Hip Resurfacing system femoral component, when used for hemi-hip arthroplasty, has been designed for cemented use in patients who are likely to outlive a conventional hip prosthesis. Femoral hip resurfacing hemi arthroplasty is most appropriate for patients with good bone quality in the femoral head and acetabulum, where the bearing surface and supportive bone structure of the acetabulum is normal, and where acetabular replacement is neither required nor desirable. Such patients will generally be under the age of 65.

• Non inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis if remaining bone stock is adequate, and osteoarthritis
• Inflammatory joint disease (IJD), e.g. rheumatoid arthritis
• Joint replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives

Additional indications include other abnormalities where major pathology affects the femoral head; where the bearing surface and supportive bone structure of the acetabulum is normal; and where acetabular replacement is neither required nor desirable

• WARNING: The Durom Femoral component is not approved for use with the Durom Acetabular cup for total hip surface replacement arthroplasty in the USA.

The Durom® Hip Resurfacing System femoral component consists of a monoblock head and slim-line femoral guide pin. The head is an extended hemisphere (greater than 180°). It is available in 12 sizes with Outside Diameters (ODs) ranging from 38mm to 60mm. The spherecity of the head is tightly controlled to less than 10 microns. The underside of the head has recesses for controlled pressurization of cement into the cancellous bone, and for rotational stability after implantation.

The provided text describes the Zimmer Durom® Hip Resurfacing System's femoral components and its FDA 510(k) clearance. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as typically found in studies for AI/software devices.

This document is a traditional 510(k) premarket notification for a physical medical device (a hip resurfacing system), not a software or AI device. Therefore, the types of performance data and study methodologies you're asking about (e.g., test sets, ground truth by experts, MRMC studies, standalone algorithm performance) are not applicable or present in this filing.

Instead, the "Performance Data (Non-clinical)" section briefly mentions:
"The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective."

This statement implies that the device underwent engineering and biomechanical testing typical for orthopedic implants, such as fatigue testing, wear testing, material characterization, and possibly cadaveric studies or computational modeling, to ensure its structural integrity, biocompatibility, and mechanical performance under simulated physiological conditions. However, the specific details, results, and acceptance criteria for these tests are not included in this summary.

In summary, based only on the provided text, I cannot answer the questions as they pertain to a software or AI device's performance study. The document outlines the device's description, intended use, and substantial equivalence to predicate devices based on material, design, and similar performance characteristics evident from non-clinical laboratory testing.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method for the test set:

   • Not Applicable: No clinical or non-clinical testing was provided, so no adjudication method is mentioned.

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 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.

6. 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.

7. 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.

8. 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.

9. 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.

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