The GM3X2IF is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GEM IF TENS device, Model GM3X2IF:

The provided text, a 510(k) summary and FDA clearance letter, does not contain detailed information about specific acceptance criteria related to device performance metrics for a clinical study, nor does it describe a study explicitly proving the device meets performance acceptance criteria in the way a modern clinical trial report would.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (IF-400 (K930535) and IF-4000 (K952683)) by showing:

Same intended use: "The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain."
Similar technological characteristics: The device "generates the small real-sine pulses of electrical current" for pain relief, similar to the predicate devices.
Compliance with applicable voluntary standards: This is the primary "acceptance criteria" presented, focusing on safety and electrical performance, rather than clinical efficacy metrics.
Software verification according to FDA guidance.

Because the document aims to establish substantial equivalence for a device type (TENS unit) where clinical outcomes are often well-established for the predicate, it typically relies more heavily on engineering verification and compliance with standards rather than de novo clinical performance studies with specific numerical acceptance thresholds.

Therefore, many of the requested sections (like sample size for test set, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied/Stated)	Reported Device Performance
Intended Use	Must align with predicate device's intended use.	"Same intended use" as IF-400 and IF-4000.
Technological Characteristics	Must be similar to predicate devices, generating small real-sine pulses of electrical current.	"Same technological characteristics" as IF-400 and IF-4000.
Safety - Electrical	Compliance with ANSI/AAMI, NS4-1985	Compliance demonstrated.
Safety - General Medical	Compliance with EN 60601-1, EN 60601-1-1, and EN 60601-1-2	Compliance demonstrated.
Software Integrity	Verification according to FDA software guidance.	Software verification carried out.
Regulatory Standing	Must maintain the same safety and effectiveness as cleared devices despite engineering differences.	"Verification and validation tests contained in this submission demonstrate that the difference... could maintain the same safety and effectiveness." (Implied acceptance met).

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

Not explicitly stated for a clinical performance test set. The "test set" here refers to engineering verification and validation tests, not a clinical trial. The provenance of these engineering tests is likely the manufacturer (Gemore Technology Co., Ltd. in Taiwan).

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)

Not applicable. This submission focuses on engineering and regulatory compliance, not clinical ground truth established by medical experts for algorithm performance.

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

Not applicable. This relates to clinical or imaging studies, which are not described here.

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. This is not an AI-assisted device and no MRMC study is mentioned.

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

Not applicable. This is not an algorithmic device in the sense of image analysis or diagnostic AI. The device itself is the "standalone" entity whose safety and basic function are tested.

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

The "ground truth" for this submission is regulatory compliance with recognized standards (electrical, medical device safety) and demonstration of functional equivalence to predicate devices through engineering verification and validation. Clinical outcomes data or expert consensus for performance as a medical AI/imaging device is not the basis for this type of 510(k) clearance for a TENS unit.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. (See point 8).

Summary Takeaway:

This 510(k) submission for the GEM IF TENS device, Model GM3X2IF, demonstrates substantial equivalence to existing predicate devices (IF-400 and IF-4000). The "acceptance criteria" are primarily established by adherence to recognized voluntary standards (ANSI/AAMI, EN 60601 series) for safety and basic functionality, along with FDA guidance for software verification. The study described is not a clinical efficacy trial in the modern sense of a performance study with specific numerical metrics for an AI or diagnostic device, but rather a set of engineering verification and validation tests designed to show that the new device's differences from the predicate do not affect intended use or alter fundamental scientific technology, thereby maintaining equivalent safety and effectiveness.

Summary

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GENIURE TEUHNULUGY UU., LI U.

510(K) SUMMARY

Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The characters appear to be "K032719". The handwriting is somewhat stylized, with the '2' resembling a 'z'. The image is in black and white and the characters are clear and legible.

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:

DEC 1 0 2003

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: July 25, 2003.

1. Name of the Device:
  GEM IF TENS, True sine interferential stimulator / Model: GM3X2IF, where X is the parameter for different housing.
1. Information of the 510(k) Cleared Device (Predicate Device):
  IF-400 (K930535) and IF-4000 (K952683).

4. Device Description:

5. Intended Use:

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

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

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6. 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.

7. Conclusions

The true sine interferential stimulator, model GM3X2IF, has the same intended use and technological characteristics as the cleared device of IF-400 (K930536), and IF-4000 (K952683). to relover, 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/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2003

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

Rc: K032719

Trade/Device Name: GM3 Series IF TENS Model GM3X2IF Regulation Number: Unclassified Generic Device Type: Interferential current therapy stimulator Regulatory Class: Unclassified Product Code: LIH Dated: July 26, 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, 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 agencics. 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. Boden S.P. Lai

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 Millenn

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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Page 1 of 1

6032719 510(k) Number (if known):

Device Name: GEM IF TENS, True sine interferential stimulator / Model: GM3X2IF, where X is the parameter for different housing with range from 0 to 5.

Indications For Use:

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sig-Of
Division of Gener
and Neurological L...

^) Number K032719

Prescription Use OR Over-The-Counter Use

(Optional Format 1-2-96)

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).