MANTRA ELECTRODE by MANTRA INTL. (HK) LTD.

The Mantra Electrode is a multi-layer structure containing conducting material and one of several types of connectors. The electrode is a multi-layer structure consisting of a layer of hydrogel, conducting film and a non-woven backing material. Various connectors can be used with the electrodes: (1) snap type lead wires for button connector type electrodes, (2) button type clectrodes, and (3) tab type electrodes.

AI/ML Overview

The provided document is a 510(k) summary for the Mantra Electrode, which is a cutaneous electrode. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria, a specific study proving device performance against such criteria, sample sizes for test or training sets, expert involvement, or MRMC studies.

Therefore, most of the requested information cannot be extracted from this document based on the provided text.

Here's a breakdown of what can and cannot be answered:

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

Cannot be provided. The document states "The device meets the mandatory performance standards" but does not define what those standards are or present any specific performance data from a study.

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

Cannot be provided. No study or test set details are mentioned in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. No ground truth establishment or expert involvement for a test set is mentioned.

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

Cannot be provided. No test set or adjudication method is mentioned.

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

Cannot be provided. This document describes a simple medical device (an electrode), not an AI or imaging diagnostic device. Therefore, an MRMC study and AI assistance are not applicable and are not mentioned.

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

Cannot be provided. As above, this is not an AI or algorithm-driven device.

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

Cannot be provided. No ground truth is mentioned. The substantial equivalence is based on "indications for use," "technological characteristics," and "biocompatibility."

8. The sample size for the training set

Cannot be provided. No training set is mentioned as this is not an AI/machine learning device.

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

Cannot be provided. No training set or ground truth for it is mentioned.

Summary of available information:

The document focuses on demonstrating substantial equivalence to a predicate device (Uni-Patch Electrode Model Re-Ply®, K983097) rather than providing detailed performance study data against specific acceptance criteria. This is common for 510(k) submissions of certain classes of devices.

The basis for substantial equivalence is listed as:

Same indications for use.
Equivalent technological characteristics and instructions for use.
Meets mandatory performance standards (though these are not detailed).
Biocompatibility established (details not provided).

Summary

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Mantra International Ltd. P.O. Box 800 Oxford, OH 45056 Tel: (740) 549-5703 FAX: (740) 549-5701

SEP 2 2 2004

510(k) Summary

Contact Person:	Brent Reider
Date of Preparation:	July 7, 2004
Trade Name:	Mantra Electrode
Common Name:	Cutaneous electrode
Classification Name:	electrode, cutaneous
Product Code:	GXY
Regulation Class:	2
Regulation Number:	882.1320

Description of the Device: - The Mantra Electrode is a multi-layer structure containing conducting material and one of several types of connectors.

The Mantra Electrode is intended to be used with Transcutaneous Intended Use: Nerve Stimulator and Electronic Muscle Stimulator Units.

Technical Characteristics: The technical characteristics of the Mantra Electrode are identical to the predicate device. The electrode is a multi-layer structure consisting of a layer of hydrogel, conducting film and a non-woven backing material. Various connectors can be used with the electrodes: (1) snap type lead wires for button connector type electrodes, (2) button type clectrodes, and (3) tab type electrodes.

This product is substantially equivalent to the Uni-Substantial Equivalence: Patch Electrode Model Re-Ply® manufactured by Uni-Patch, Inc., Wabasha, Minnesota (K983097).

Substantial equivalence is based upon:

. The Mantra Electrode has the same indications for use as the predicate device.

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The Mantra Electrode has equivalent technological characteristics and instructions . for use, as compared to the predicate device.
The device meets the mandatory performance standards. .

The biocompatibility of the electrodes has been established. .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2004

Mantra International Ltd. C/o Mr. Robert B. Spertell RBS Technologies, LLC 10235 Glade Avenue Chatsworth, California 91311

Re: K041902

Trade/Device Name: Mantra Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: June 25, 2004 Received: July 14, 2004

Dear Mr. Spertell:

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. Robert B. Spertell

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), please contact the Office of Compliance at (301) 594-4659. 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 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,

Mark A. Wilkerson

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

K 041902 510(k) Number (if known):

Device Name: Mantra Electrode

The Mantra Electrode is intended to be used with Transcutaneous Indications for Use: Nerve Stimulator and Electronic Muscle Stimulator Units.

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

Over-The-Counter-Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mark A. Mellers

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

510(k) Number K041902

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).