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Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) are intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older.

The Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1 (herein collectively referred to as "Rapid2 Magnetic Stimulators") are computerized, electromechanical medical devices that provide brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older. The subject device is intended to be used in hospitals and clinics such as pain management clinics.

Rapid2 Magnetic Stimulators are integrated systems consisting of a combination of hardware, software, and accessories. Rapid2 Magnetic Stimulators are offered in multiple configurations:

• Rapid2
• Super Rapid2
• Super Rapid2 Plus1

All three configurations have identical intended use/indications for use, common specifications, equivalent performance characteristics and equivalent composition to each other. Specifically, Rapid2 and Super Rapid2 have received prior clearance under K051864 for Peripheral Nerve Stimulation (Product Code: GWF, Regulation 21 CFR 882.1870). All Rapid2 Magnetic Stimulators are made up of components that have received prior clearance under K051864 (e.g., the 3190-00, 3192-00 and 3193-00 coils) and components which have received prior clearance under K051864 but have received modifications due to aspects like obsolescence (Mainframe, Power Supply etc.).

All Rapid2 Magnetic Stimulators are composed from the following main components:

• Stimulating Unit & Power Supply
• User Interface
• Stimulating Coil
• System and Stimulating Coil Cart and Holding Arm

Rapid2 Magnetic Stimulators include temperature monitoring via two independent temperature sensors to ensure surfaces of the coils do not reach unacceptable levels. The cut-off is set to act at 40°C at which point the system will automatically be disabled. Over-temperature conditions are also communicated on the User Interface (UI) via a temperature gauge and alarm system. Rapid2 Magnetic Stimulators also includes the 3910-00 air-cooled coil to further mitigate any temperature conditions. The 3910-00 air-cooled coil comes with all 3 configurations (Rapid2, Super Rapid2 and Super Rapid2 Plus1) as standard.

The provided document is an FDA 510(k) Clearance Letter for the Rapid2 Magnetic Stimulators. It does NOT contain information about a study proving the device meets acceptance criteria related to its performance in pain relief. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of technical characteristics, safety standards compliance, and physical properties.

The document does not describe an AI/ML-driven device, nor does it present results from a clinical study with patients or human readers using AI. The acceptance criteria and performance metrics described are related to physical and electrical characteristics of the magnetic stimulator, not diagnostic accuracy or clinical effectiveness in a traditional sense of "performance" as one might expect for an AI diagnostic device.

Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth type) cannot be answered based on the provided text, as they pertain to clinical or AI/ML performance evaluation, which is not the subject of this 510(k) summary.

However, I can extract information related to the technical acceptance criteria and how they align with the device's measured performance as described in the summary:

Acceptance Criteria and Device Performance (Based on Technical and Safety Equivalence)

The acceptance criteria for the Rapid2 Magnetic Stimulators are primarily based on demonstrating substantial equivalence to the predicate device (MagVenture Pain Therapy) in terms of technical characteristics, safety, and effectiveness for the stated indications for use. The "performance" reported is adherence to these characteristics and safety standards.

Regarding the specific questions that cannot be answered from the provided text:

2. Sample sizes used for the test set and the data provenance: Not applicable or provided. The "test set" here refers to non-clinical testing of device characteristics, not a clinical study on patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context would implicitly be engineering specifications, laboratory measurements, and standard compliance testing, not expert clinical assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided. No adjudication process detailed for establishing technical specifications.
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. This is not an AI/ML device, nor is it a diagnostic device being evaluated for reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance evaluation is based on engineering specifications, direct physical measurements (e.g., of magnetic fields, temperatures, electrical properties), and compliance with international safety and performance standards (e.g., IEC 60601 series, ISO 10993).
8. The sample size for the training set: Not applicable or provided. This device does not use a "training set" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable or provided.

In summary, the provided document details the 510(k) clearance process for a non-AI/ML magnetic stimulator for pain relief. The "acceptance criteria" and "performance" are framed around demonstrating substantial technical and safety equivalence to a legally marketed predicate device, rather than clinical efficacy data from patient studies or AI algorithm performance metrics.

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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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Stimulation of peripheral nerves.

Not Found

The provided document is an FDA 510(k) clearance letter for the Magstim Rapid device. It states that the device is substantially equivalent to legally marketed predicate devices for the indication of "Stimulation of peripheral nerves."

However, this document does not contain any information regarding acceptance criteria, device performance metrics, study designs (e.g., sample sizes, ground truth establishment, expert qualifications, or MRMC studies), or specific results of any performance studies.

Therefore, I cannot fulfill your request for the information outlined in your prompt using only the provided text. The document is an administrative clearance letter, not a technical report detailing performance assessment.

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