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The NuVasive® Mesh is indicated for use in the reinforcement of weak bony tissue in orthopedic procedures.

The NuVasive® Mesh is a rhombic pattern surgical mesh device intended for the reinforcement of weak bony tissue during orthopedic surgical procedures. The implant is available in preformed round or oval cylinders, in a variety of different sizes.

The provided text does not contain information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria. The submission is a 510(k) summary for a medical device (NuVasive® Mesh), which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria.

The submission explicitly states:

• "G. Summary of Non-Clinical Tests (Not Applicable)."
• "H. Summary of Clinical Tests (Not Applicable)."
• "I. Conclusions of Non-Clinical and Clinical Tests (Not Applicable)."

This indicates that no specific non-clinical or clinical studies, as typically understood for demonstrating performance against acceptance criteria, were presented or required for this 510(k) submission. The FDA clearance was based on substantial equivalence to existing devices.

Therefore, the requested information elements cannot be extracted from the provided text.

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