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.

AI/ML Overview

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.

Parameter	Magstim Rapid2 & Magstim Super Rapid2 (New Device)	K992911 (Predicate)	Cadwell K905059 (Predicate for 60Hz Comparison)	"Acceptance Criteria" (Implied by Predicate Performance)
Field Strength	1.2 Tesla for Double 70mm Coil supplied with System	1.2 Tesla (depends on coil type and power level)	(Not specified for Cadwell)	Comparable to 1.2 Tesla
Super Frequency	60Hz (Magstim Super Rapid2)	50Hz (Super Rapid)	(Not specified for Cadwell in same context)	Comparable to 50Hz (Super Rapid)
Frequency	36Hz (Magstim Rapid2)	25Hz (Rapid)	(Not specified for Cadwell in same context)	Comparable to 25Hz (Rapid)
Frequency Resolution	1Hz Steps (user controllable)	1Hz Steps (User controllable)	(Not specified for Cadwell)	1Hz Steps (User controllable)
Train Duration	Up to 10 Seconds depending on frequency and coil	Up to 10 seconds depending on frequency and coil	(Not specified for Cadwell)	Up to 10 seconds depending on frequency and coil
Train Resolution	0.1 seconds	0.1 seconds	(Not specified for Cadwell)	0.1 seconds
Single Stimulus Mode	Yes	Yes	(Not specified for Cadwell)	Yes
Interpulse Spacing	Up to 250 stimuli per stimulus train	Up to 250 stimuli per stimulus train	(Not specified for Cadwell)	Up to 250 stimuli per stimulus train
Number of Stimuli	Up to 250 stimuli per stimulus train	Up to 250 stimuli per stimulus train	(Not specified for Cadwell)	Up to 250 stimuli per stimulus train
Coil Temperature	5-40°C Operating Range	5-40°C Operating Range	(Not specified for Cadwell)	5-40°C Operating Range
36Hz/60Hz	Max 30% of power / Max 37% of power		Unknown / Max 40% of power (for 60Hz in Cadwell)	Max 40% of power (for 60Hz)
100% Power	11Hz/22Hz		25Hz	25Hz

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:

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).
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.
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.
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.
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.
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.
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."
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.

Summary

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K051864

DEC 2 1 2005 Page 1 of 3

510(K) SUMMARY

Magstim Company Ltd - Magstim Rapid2 and Magstim Super Rapid2

Anthony Thomas Preparer/ Contact The Magstim Company Limited Spring Gardens, Whitland. Carmarthenshire, Wales, UK. SA34 OHR Phone +44 (0) 1994 242905 +44 (0) 1994 240061 Fax Email: Anthony.thomas@magstim.com

Manufacturer

Magstim Company Limited

Date Summary was prepared: Name of the Device:

June 16th 2005 Magstim Rapid2 and Magstim Super Rapid2

Identification of predicate device(s): Magstim Rapid K992911 Cadwell High Speed Magnetic Stimulator K902059 Dantec Mag Pro K926516

Description of the device and modifications:

This submission is being made because the Magstim Company, referred to as This submission is being made because eted under K992911 to replace the external Magsimil, has mounted the device marked marked with the system is 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.

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K05 1864

Page 2 of 3

Intended Use: Stimulation of Peripheral Nerves.

Substantial Equivalence:

Parameter	Magstim Rapid2 &Magstim Super Rapid2	K992911
Field Strength	1.2 Tesla for Double70mm Coil supplied withSystem.	1.2 Tesla (depends on coiltype and power level)
Super Frequency	60Hz (Magstim SuperRapid2)	50Hz (Super Rapid)
Frequency	36Hz (Magstim Rapid2)	25Hz (Rapid)
Frequency Resolution	1Hz Steps (usercontrollable)	1Hz Steps (Usercontrollable)
Train Duration	Up to 10 Secondsdepending on frequencyand coil	Up to 10 secondsdepending on frequencyand coil
Train Resolution	0.1 seconds	0.1 seconds
Single Stimulus Mode	Yes	Yes
Interpulse Spacing	Up to 250 stimuli perstimulus train	Up to 250 stimuli perstimulus train
Number of Stimuli	Up to 250 stimuli perstimulus train	Up to 250 stimuli perstimulus train
Coil Temperature	5-40°C Operating Range	5-40°C Operating Range

60Hz Comparison

Parameter	Magstim Rapid²/ MagstimSuper Rapid²	Caldwell High SpeedMagnetic StimulatorK905059
36Hz/60Hz	Max 30% of power/ Max37% of power	Unknown/ Max 40% ofpower
100% Power	11Hz/22Hz	25Hz

Software documentation and testing, environmental and EMC testing, as well as Software documentation and testing, on measurements where provided to demonstrate safety and performance.

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K051864

Page 3 of 3

Conclusion

The modified device, the Magstim Rapid² (Magstim SuperRapid') is substantially, the Alabantially, the Caldwell High The modified device, the Magstim Rapid (Magstim Super Rapid) and the Caldwell High Speed Magnetic Stimulator.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the HHS emblem, which is a stylized representation of a human figure with outstretched arms, symbolizing care and protection. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2005

Mr. Anthony Thomas The Magstim Company Limited Spring Gardens, Whiteland Carmarthenshire, Wales UNITED KINGDOM

Re: K051864

K05780+
Trade/Device Name: Magstim Rapid2, Magstim Super Rapid2 Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: November 21, 2005 Received: November 21, 2005

Dear Mr. Thomas:

We have reviewed your Section 510(k) premarket notification of intent to narket the device We have reviewed your because 310(1) for device is substantially equivalent (for the referenced above and have determined and to legally marketed predicate devices marketed in indications for use stated in the enclosates, to regional date of the Medical Device interstate collinered prior to May 20, 1978, as secured with the provisions of Amendinents, of to devrees that have a Act (Act) that do not require approval of a premarket the Federal Pood, Drug, and Oosmetis , therefore, market the device, subject to the general approval application (1 Miry) - 1 ou - general controls provisions of the Act include controls provisions of the Feat - tion Jisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III IT your device to such additional controls. Existing major regulations affecting (FMA), it may of subject to sach adatof Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the South no nouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements mean that I 177 mas made a and regulations administered by other Federal agencies. of the Act of any I oderal bables is requirements, including, but not limited to: registration r od linese comply while a 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 OF R Part 807), quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality sion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Thomas

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocent marieming of substantial equivalence of your device to a premarket notification. The PDF mails in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), IT you desire specific advice for your de at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours,

Sincerely yours,

Barbace Fuehub

Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Revised

Indications for Use

510(k) Number (if known): K051864 510(k) Number (if Khown): 100 Norshim Super Rapid2
Device Name: Magstim Rapid2, Magstim Super Stimulation Device Name: "Magstini Rupla", Magstin Theree Stimulation

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of CDRH, Office of Device Evaluation (ODE)

charbare Buchind for mixon

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K051864

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).