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Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

This femoral stem is for cementless use only.

The Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology is a modular, wedgeshaped stem that is coated with commercially pure titanium alloy plasma spray that is available with and without Calcicoat Ceramic Coating. This stem is designed for cementless use only.

The modular neck option allows for soft tissue balancing and easier restoration of the hip joint center of rotation. The modularity feature will allow surgeons to independently equalize leg length and optimize offset while, at the same time, maximizing joint stability for a variety of different patients' anatomies.

The provided text describes a 510(k) premarket notification for a medical device, the Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish independent safety and effectiveness.

Therefore, the requested information regarding acceptance criteria for a device's performance, a study proving it meets these criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not applicable in this context.

Here's why and what the document does provide:

1. Acceptance Criteria and Reported Device Performance:

   • Not applicable for this type of submission. A 510(k) does not typically involve setting specific performance acceptance criteria for a new device's performance that then needs to be met by a study. Instead, the device's design, materials, manufacturing, and intended use are compared to an existing predicate.
   • The document states: "Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis with Modular Neck Technology met performance requirements and is as safe and effective as the predicate devices." This is a general statement indicating comparative performance, not performance against independent numerical acceptance criteria.

2. Sample Size for Test Set and Data Provenance:

   • Not applicable. There is no "test set" in the sense of a clinical or retrospective dataset used to directly evaluate the device's performance against specific metrics. The non-clinical testing refers to bench testing (e.g., mechanical, fatigue, wear) to ensure the device performs similarly to the predicate under simulated conditions. The document does not specify sample sizes for these tests.

3. Number of Experts and Qualifications for Ground Truth:

   • Not applicable. There is no "ground truth" to establish in the context of expert review for diagnostic accuracy or similar performance metrics. The assessment is primarily engineering-based for mechanical properties and a comparison to the predicate's known safety and efficacy profile.

4. Adjudication Method:

   • Not applicable. No human adjudication of results is described, as there isn't a complex diagnostic or outcome assessment being performed by human readers for the device itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable. MRMC studies are used to assess the diagnostic accuracy or effectiveness of an imaging algorithm or diagnostic device, often comparing human reader performance with and without AI assistance. This device is a hip implant, not an imaging or diagnostic AI device.

6. Standalone Performance Study:

   • Not applicable. A "standalone" study typically refers to the algorithmic performance of an AI or diagnostic device without human interaction. This device is a physical implant.

7. Type of Ground Truth Used:

   • Not applicable. Ground truth for clinical outcomes or diagnostic accuracy is not relevant here. The "proof" is based on non-clinical engineering testing and the demonstrated conceptual equivalence to established predicate devices.

8. Sample Size for Training Set:

   • Not applicable. This device is a physical hip implant, not a machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established:

   • Not applicable. As above, no training set for an algorithm is involved.

In summary, the provided document is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of materials, design, and intended use, rather than detailed clinical studies with specific performance acceptance criteria, expert adjudication, or AI algorithm evaluation.

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