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The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Cephalomedullary nails include: Compound and simple shaft fractures, Proximal, metaphyseal and distal shaft fractures, Segmental fractures, Comminuted fractures, Fractures involving osteopenic and osteoporotic bone, Pathological fractures, Fractures with bone loss, Pseudoarthrosis, non-union, mal-union and delayed union, Periprosthetic fractures, Surgically created defects such as osteotomies, Intertrochanteric and subtrochanteric fractures

The Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps are available to prevent tissue ingrowth into nail threads and increase the length of the nail if desired. These devices are made from Ti-6Al-4V alloy and are provided sterile.

The provided text describes a 510(k) premarket notification for a medical device, the Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short. This document focuses on demonstrating that the modified device is substantially equivalent to existing predicate devices, rather than on proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information cannot be directly extracted from this document, as it outlines a different type of regulatory submission.

However, I can extract information regarding the performance data used to support the substantial equivalence claim.

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The document does not explicitly state numerical "acceptance criteria" in the way a clinical trial would (e.g., target specificity or sensitivity values). Instead, the implicit acceptance criterion is that the modifications "would not affect safety and effectiveness" when compared to the predicate devices.
• Reported Device Performance:
  • Fatigue strength evaluation: Performed on the proximal segment of the subject nail.
  • Distal tip evaluation: Assessment of tensile stress under cantilever loading.
  • Conclusion: "The results of non-clinical (lab) performance testing demonstrate that the subject devices are safe and effective and substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance:

• Sample Size: This is not specified for the non-clinical testing. It would typically be a engineering test sample size, not human subjects.
• Data Provenance: "Non-clinical (lab) performance testing." This implies in-vitro or bench testing, not data from human subjects or clinical settings.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. For non-clinical (lab) performance testing of mechanical properties, "ground truth" is established through engineering and material science principles and measurements, not expert clinician consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. As this involves direct mechanical testing, there is no need for adjudication as typically seen in clinical image interpretation or diagnosis.

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:

• No. This document describes the regulatory approval of a hardware medical device (intramedullary nail), not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• No. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Engineering/Material Science Standards: The "ground truth" for the non-clinical tests would be established by industry standards, engineering specifications, and validated measurement techniques for fatigue strength and tensile stress.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of this type of non-clinical mechanical performance testing.

9. How the ground truth for the training set was established:

• Not Applicable.

Summary Table of Available Information:

This document is primarily concerned with showing substantial equivalence to existing devices through engineering tests, rather than a clinical trial with human subjects and diagnostic performance metrics.

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