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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 retrograde femoral nails in the femur include: Compound and simple shaft fractures, Proximal, metaphyseal, and distal shaft fractures, Segmental fractures, Closed supracondylar fractures, Severely comminuted supracondylar fractures with articular involvement, Fractures involving femoral condyles, Comminuted fractures, Fractures involving osteopenic and osteoporotic bone, Pathological fractures, Fractures with bone loss, Pseudoarthrosis, non-union, and mal-union, Periprosthetic fractures, Poly trauma patients.

The Zimmer Natural Nail System Retrograde Femoral Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. They are inserted into the femur in a retrograde mode and 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, cortical washers and cortical nuts are available for use with the system. All components are manufactured from Ti-6Al-4V alloy. The cortical nut also contains UHMWPE.

This document refers to a 510(k) premarket notification for the Zimmer® Natural Nail™ System Retrograde Femoral Nail. The device is an intramedullary fixation rod. The 510(k) summary explicitly states that clinical data and conclusions were not needed for this device (Page 1, "Clinical Performance and Conclusions"). This means the device approval did not rely on studies demonstrating its performance against acceptance criteria in a clinical setting.

Instead, the approval was based on non-clinical (lab) performance testing demonstrating that the devices are safe, effective, and substantially equivalent to predicate devices. The listed tests are mechanical in nature, assessing the physical properties and durability of the nail and screws.

Given this, I cannot provide the detailed information requested in your prompt as the study described in the document is a non-clinical, mechanical testing study, not a clinical study involving human subjects or AI performance.

Therefore, the following information is not applicable or extractable from the provided document:

1. A table of acceptance criteria and the reported device performance (for clinical performance): Not applicable, as no clinical performance study was conducted. The document lists mechanical performance tests (e.g., fatigue, torsional stiffness, insertion load) but does not provide specific acceptance criteria or quantitative results for these tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical test set was used. For the non-clinical tests, sample sizes for mechanical testing are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical ground truth was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is a medical device for fracture fixation, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information regarding performance:

• Acceptance Criteria (Mechanical Testing): Not explicitly stated in terms of quantitative values. The general criterion is that the device "demonstrates that the devices are safe and effective and substantially equivalent to the predicate devices."
• Reported Device Performance (Mechanical Testing): The document states "The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices." Specific quantitative results are not provided in this 510(k) summary.
• Study Type: Non-clinical (lab) performance testing, focusing on mechanical properties, not clinical efficacy or diagnostic accuracy.
• Tests Performed: Proximal Nail Fatigue Test, Distal Nail Fatigue Test, Midshaft Nail Analysis, Nail Torsional Stiffness Analysis, Screw Bending Fatigue Test, Screw Insertion Load Test, Screw Insertion Torque Test, Screw Torque to Failure Test, and Shelf Life Testing of UHMWPE.

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