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Stimulation of Peripheral Nerves.

This submission is being made because the Magstim Company, referred to as Magsimil, has mounted the device marked under K992911 to replace the external laptop interfaced with the main system via a computer with an embedded interest. Previously, a laptop interfaced with the main bespoke touch-screen display moduler. The new system architecture means that unnt via the I CNCD I V or of also ove controlling the system, resulting in it no longer there is dedicated, in-nouse, so Microsoft Windows operating environment. The requiring all external laptop of Interesses wo and four booster modules, which has been replaced with single and dual module power supplies in the Rapid'. 2001 has been replaced with single are of coils are also introduced with this 510(k), generation contral Magstim Rapid coil family in K992911 can be used with the Rapid2, and the differenced between the 2nd generation and the original coils do not Rapid , and the unrelemed between ss. The intended use of the Magstim Rapid2 and Talse Issues of Salery and Chrostrents in K992911, and the frequency output has been Magstin Super Rapid '15 the Same as also as a power levels, which is consistent with the Changed High Speed Magnetic Stimulator in K905059.

The provided document is a 510(k) summary for the Magstim Rapid2 and Magstim Super Rapid2 devices. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study designed to establish new acceptance criteria or device performance through a standalone clinical trial with statistically significant outcomes against predefined acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies are not available in this document.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study. Instead, it compares the technical specifications and performance characteristics of the new devices (Magstim Rapid2 & Magstim Super Rapid2) against predicate devices (Magstim Rapid K992911 and Cadwell High Speed Magnetic Stimulator K905059) to demonstrate "substantial equivalence." The "performance" reported is essentially the device's technical specifications.

The "acceptance criteria" here is implicitly demonstrating that the new devices' specifications meet or exceed the performance of legally marketed predicate devices, thus ensuring they are equally safe and effective for their intended use.

Specific Study Information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable / Not provided. This document does not describe a clinical study with a "test set" of patients or data in the context of a diagnostic or treatment effectiveness study where such metrics are typical. The evaluation is based on technical specifications and engineering tests. Data provenance for such engineering tests is not specified, but it would have been conducted by the manufacturer, Magstim Company Limited (UK).

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

   • Not applicable / Not provided. No "ground truth" in the clinical sense (e.g., disease diagnosis) was established by experts for a test set in this 510(k) summary. The "ground truth" for the device's technical performance would be objective measurements and engineering standards.

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

   • Not applicable / Not provided. No adjudication of clinical data was performed as no clinical "test set" was described.

4. 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 / Not provided. This is not an AI-assisted diagnostic device, and no MRMC study was conducted or described.

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

   • Not applicable / Not provided. This is an electromagnetic stimulator, not an algorithm, and no standalone performance study in this context was described. The "standalone" performance here relates to the technical specifications of the device itself.

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

   • Not applicable / Not provided for clinical ground truth. The "ground truth" for this submission are the technical specifications and performance characteristics of the predicate devices and the new devices, as measured and verified through engineering and bench testing. These include parameters like field strength, frequency, train duration, etc., as shown in the tables.

7. The sample size for the training set:

   • Not applicable / Not provided. As this is not an AI/machine learning device, there is no "training set."

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

   • Not applicable / Not provided. No training set exists for this type of device.

Overall Conclusion from the document:

The submission focuses entirely on substantial equivalence to predicate devices through technical comparisons and engineering performance data. The FDA agreed that "Software documentation and testing, environmental and EMC testing, as well as on measurements where provided to demonstrate safety and performance" were sufficient to establish this. No clinical studies are mentioned.

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