Indications For Use (Available for GM3X0T/GM3AX0T, GM3X0PP/GM3AX0PP, and TENS function of GM3X0TE/GM3AX0TE): This device is a prescription device and only for symptomatic relief of chronic intractable pain.

Indications For Use (Available for GM3X0E/GM3AX0E, & 'EMS function' of GM3X0TE/GM3AX0TE):

Relaxation of muscle spasms.
Prevention or retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Maintaining or increasing range of motion.

Indications For Use (Available for GM3X0PE/GM3AX0PE):

Relaxation of muscle spasms.

Device Description

The GEM-STIM TENS series, including GM3X0T/GM3AX0T, GM3X0E/GM3AX0E, GM3X0PP/GM3AX0PP, GM3X0PE/GM3AX0PE, and GM3X0TE/GM3AX0TE are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.

GEM-STIM TENS series, models GM3X0T/GM3AX0T, GM3X0E/GM3AX0E, GM3X0PP/GM3AX0PP, GM3X0PE/GM3AX0PE, and GM3X0TE/GM3AX0TE, consist mainly of two parts: the stimulus generator, electrode. The stimulus generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.

The stimulation mode for GEM-STIM TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

AI/ML Overview

This 510(k) premarket notification is for the GEM-STIM TENS series of devices (Models GM3XY and GM3AXY), which are transcutaneous electrical nerve stimulators (TENS) and powered muscle stimulators (EMS). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

The acceptance criteria for this device and the study that proves it meets these criteria are primarily based on demonstrating substantial equivalence to predicate devices through compliance with recognized standards and non-clinical testing. The document explicitly states that formal clinical studies with specific performance metrics are not required in this context.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance/Compliance
Safety and Effectiveness	Substantially equivalent to predicate devices	Verified and validated through non-clinical tests to maintain same safety and effectiveness as cleared devices.
Electrical Safety	ANSI/AAMI, NS4-1985	Complies with standard.
	EN 60601-1	Complies with standard.
Electromagnetic Compatibility (EMC)	EN 60601-1-2	Complies with standard.
Medical Electrical Equipment (General)	EN 60601-1-1	Complies with standard.
Software Validation	FDA software guidance	Software verification carried out.
Intended Use	Same as predicate devices	Same intended use as predicate devices.
Technological Characteristics	Same as predicate devices	Same technological characteristics as predicate devices.
Risk Assessment	Engineering difference does not: (1) affect intended use or (2) alter fundamental scientific technology	Demonstrated through verification and validation that differences do not impact safety or effectiveness.

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

The document does not specify a "test set" in the context of clinical performance or a patient-based study. The "test set" here refers to the parameters and functions of the device itself being tested for compliance with standards.

Sample Size: Not applicable in the context of a biological or patient sample size. The tests performed are on the device itself.
Data Provenance: The tests are non-clinical, likely conducted by the manufacturer (GEMORE TECHNOLOGY CO., LTD., Taiwan) or accredited testing laboratories. The document doesn't explicitly state the country of origin of the testing data beyond the submitter's location in Taiwan. The study is not a retrospective or prospective clinical study but rather engineering and software verification and validation.

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)

This section is not applicable as the submission relies on demonstrating compliance with recognized engineering and safety standards, and software verification guidance, rather than expert-derived ground truth from clinical images or patient outcomes. The "ground truth" is defined by the technical specifications and performance requirements outlined in the standards, and the predicate devices' established safety and effectiveness.

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

None. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth or interpret results. This submission focuses on non-clinical testing and compliance with predefined standards.

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. An MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging devices often involving AI, which is not the nature of the GEM-STIM TENS device.

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

Yes, in spirit. The "standalone" performance here refers to the device's technical specifications and electrical output conforming to the relevant standards (ANSI/AAMI, EN 60601-1, EN 60601-1-1, EN 60601-1-2) and the software performing as intended according to FDA software guidance. There is no "human-in-the-loop" performance test described in the context of the substantial equivalence demonstration, as the device's fundamental function is electrical stimulation, not interpretation or decision-making. The safety and effectiveness are established by its design and adherence to these standards.

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

The "ground truth" in this context is based on:

Compliance with recognized voluntary standards: ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2. These standards define the acceptable performance and safety criteria for such devices.
FDA software guidance: Ensuring the software functions as designed and risks are mitigated.
Predicate devices' established safety and effectiveness: The fact that the predicate devices (Well-Life WL-2203, WL-2204, WL-2205) were already cleared by the FDA implies their safety and effectiveness form the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI models that require a "training set" in the conventional sense. The "training" for the device's development involves engineering design, component selection, and adherence to established medical device manufacturing practices and standards.

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

Not applicable for the same reason as point 8.

Summary

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DEC 1 0 2003

510(K) SUMMARY

Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The characters are "K032720". The characters are written in black ink on a white background.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

Submitter's Identifications: 1. GEMORE TECHNOLOGY CO., LTD. 11FL., NO. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan
Contact: Boden S.P. Lai General Manager

Date of Summary Preparation: August 29,2003.

1. Name of the Device:
  GEM-STIM TENS/Model GM3XY and GM3AXY where "X" is parameter for different outlook which may be different from 0~5. "Y" is parameter for different operation type, which may be different with the parameter of "OT", "OE", "OPP", "OPE", and "OTE".
Information of the 510(k) Cleared Device (Predicate Device): K021359 & K020314. 3.
1. Device Description:

1. Intended Use:
  On the instruction manual of each model, the intended uses and contraindication are defined very clearly. Please see the information of instruction manuals in clause 7.6 of this submission document.

In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.

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ATTACHMENT 3-1

Page 1 of 1 .

2720 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: GEM-STIM TENS/Model GM3XY and GM3AXY where "X" is parameter for different outlook, "X" may be different from 0~5, "Y" is parameter for different operation type, "Y" may be different with one of the following parameters, 'OT', 'OE', 'OPP', 'OPE' and 'OTE'.

Indications For Use (Available for GM3X0T/GM3AX0T, GM3X0PP/GM3AX0PP, and TENS function of GM3X0TE/GM3AX0TE):

This device is a prescription device and only for symptomatic relief of chronic intractable pain.

Indications For Use (Available for GM3X0E/GM3AX0E, & 'EMS function' of GM3X0TE/GM3AX0TE):

Relaxation of muscle spasms. .
· Prevention or retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education. .
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. ●
Maintaining or increasing range of motion. .

Indications For Use (Available for GM3X0PE/GM3AX0PE):

Relaxation of muscle spasms. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

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KO32720

1. Comparison to the 510(k) Cleared Device (Predicate Device):
- (1) The new model GM3X0T/GM3AX0T and GM3X0PP/GM3AX0PP are substantially equivalent to the Well-Life clear model WL-2203 (K021359).
- (2) The new model GM3XQE/GM3AX0E. GM3X0PE/GM3AX0PE are substantially equivalent to the Well-Life clear model WL-2204 (K020314).
- (3) The new model GM3X0TE/GM3AX0TE is substantially equivalent to the Well-Life clear model WL-2205 (K021359 & K020314).
1. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.

1. Conclusions
  The GEM-STIM TENS series, including GM3X0T/GM3AX0T, GM3X0E/GM3AX0E. GM3X0PP/GM3AX0PP, GM3X0PE/GM3AX0PE, and GM3X0TE/GM3AX0TE, have the same intended use and technological characteristics as the cleared device of WL-2203, WL-2204, and WL-2205. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEC 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Boden S.P. Lai General Manager Gemore Technology Co., Ltd. 11FL., No. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan

Re: K032720

Trade/Device Name: GEM-STIM Models GM3X0T. GM3AX0T. GM3X0PP. and GM3AX0PP Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ

Trade/Device Name: GEM-STIM Models GM3X0E, GMAX0E, GM3X0PE, and GM3X0PE Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF

Trade/Device Name: GEM-STIM Models GM3X0TE and GM3AX0TE Regulation Numbers: 21 CFR 890.5850, 21 CFR 882.5890 Regulation Names: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: IPF, GZJ

Dated: July 21, 2003 Received: September 12, 2003

Dear Mr. Lai:

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. Ilsuing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Mr. Boden S.P. Lai

If your device is classified (see above) into cither 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.

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 vours.

b Mark A. Melkerson

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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ATTACHMENT 3-1

Page

510(k) Number (if known):

K032720

parameters_ '0T', '0E', '0PP', '0PE' and '0TE'.

Indications For Use (Available for GM3X0T/GM3AX0T, GM3X0PP/GM3AX0PP, and TENS function of GM3X0TE/GM3AX0TE):

I his fullietion of Gillering of Giller and only for symptomatic relief of chronic intractable pain.

Indications For Use (Available for GM3X0E/GM3AX0E, & 'EMS function' of GM3X0TE/GM3AX0TE):

Relaxation of muscle spasms. .
Prevention or retardation of disuse atrophy. .
Increasing local blood circulation. �
Muscle re-education. ●
Muscle re oudouloni
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. .
Maintaining or increasing range of motion. .

Indications For Use (Available for GM3X0PE/GM3AX0PE):

Relaxation of muscle spasms. .
Image /page/5/Picture/17 description: The image shows the text "Prescription Use (Part 21 CFR 801 Subpart D)". There is a line underneath the text with an X above the line. The text is in a simple, sans-serif font and is left-aligned.

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, O
Mark A. Millerson

(Optional Format 3-10-98)

evice Evaluation (ODE)

K030720 Page 2 of 3

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).