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Stimulation of peripheral nerves for diagnostic purposes.

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The provided document is a 510(k) clearance letter from the FDA for the Magstim Model 200-2 with Double 70mm Remote Coil, an evoked response electrical stimulator. This letter indicates that the device has been found substantially equivalent to a predicate device already on the market.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, or the details of a study that proves the device meets specific criteria.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive efficacy studies with detailed acceptance criteria and performance metrics typically associated with new or high-risk device approvals.

Therefore, I cannot provide the requested information based on the given input. The document explicitly states the device is for "Stimulation of peripheral nerves for diagnostic purposes" and that it is substantially equivalent to a predicate device, but it doesn't offer the specific study details you've asked for.

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