The provided text is a 510(k) summary for a neuromotor stimulator (NMS) device. It states that clinical testing was "Not applicable" because the device demonstrated substantial equivalence to a predicate device through bench testing of electrical output characteristics. Therefore, a study demonstrating the device meets specific acceptance criteria as you've requested was not performed, nor was it required for this 510(k) clearance.

This means I cannot provide the detailed information you've asked for regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth, as these elements were not part of the submission or FDA's review for this particular device based on the provided document.

Here's a summary based on the information available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not Applicable - Clinical testing was not performed based on substantial equivalence to a predicate device.	The CLASSIC NMS™ is substantially equivalent in electrical output to the predicate device, as determined by bench testing.

2. Sample sized used for the test set and the data provenance

Sample Size: Not applicable, as no clinical test set was used. Bench testing was performed on the device itself.
Data Provenance: Not applicable.

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

Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was used.

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

No MRMC comparative effectiveness study was done. This device is a neuromotor stimulator, not an AI-assisted diagnostic or imaging device, so "human readers" and "AI assistance" are not relevant in this context.

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

Not applicable. This is a physical neuromotor stimulator, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable, as no clinical ground truth was established or used. The basis for clearance was substantial equivalence in electrical output characteristics to a predicate device.

8. The sample size for the training set

Not applicable, as no clinical training set was used.

9. How the ground truth for the training set was established

Not applicable, as no clinical training set was used.

Summary

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K021905

5 2002 SEP

11 Appendix : 510 (k) Summary

Christian E. Hunt Submitter's Information: Care Rehab® Phone: 1-703-448-9644 1124 Dominion Ct FAX: 1-703-356-2182. McLean, VA 22102 June 7, 2002 Date of preparation: CLASSIC NMS™ Proprietary Name: Neuromuscular Stimulator Common Name: Powered Muscular Stimulator Classification Name: 21 CFR 890.5850. Device Classification: Class II Ortho Dx (K971542) Predicate Device: A portable NMS device for pain control. Description of Device: Intended Use: Relaxation of muscle spasms ﺘﻌ Prevention or retardation or disuse atrophy -Increasing local blood circulation -Muscle re-education -Immediate post-surgical simulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion -The CLASSIC NMS™ has technological characteristics that are Technological Comparison: substantially equivalent to those of the predicate device, as determined by bench testing. It differs technologically only by the use of jacks and cables which comply with FDA's Fnal Rule "Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables." The labeling of the CLASSIC NMS™ is substantially equivalent to that Labeling Comparison: of the predicate device. Bench testing demonstrated that the output characteristics or CLASSIC Nonclinical Testing: NMS™ are substantially equivalent to that of the predicate device. Clinical Testing: Not applicable. The CLASSIC NMS™ is substantially equivalent in electrical output to Conclusions from Testing: the predicate device and any differences between the devices do not pose new questions of safety and effectiveness.

510(k) Summary

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 2002 SEP

Christian E. Hunt President Care Rehab® 1124 Dominion Court McLean, Virginia 22102

Re: K021905

Trade/Device Name: Classic NMSTM Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: June 7, 2002 Received: June 10, 2002

Dear Mr. Hunt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Christian Hunt

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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 yours,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

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Indications for Use 4

510(k) Number:

Device Name: CLASSIC NMS™

Statement of Indication of Use:

The Classic NMS is recommended for use for the following conditions:

Relaxation of muscle spasms 1 .
Prevention or retardation of disuse atrophy 2.
1. Increasing local blood circulation
Muscle re-education 4.
Immediate post-surgical simulation of calf muscles to prevent venous thrombosis ર :

1904

Maintaining or increasing range of motion 6.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative and Neurological Devices

510(k) Number K021905

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).