The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A50IF are the device which generates the small true-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.

AI/ML Overview

This 510(k) summary describes a submission for the Gemore IF True Sine Interferential Stimulator (Models GM3A001F/GM3A10IF/GM3A20IF/GM3A50IF). The submission aims to demonstrate substantial equivalence to a predicate device (Gemore IF TENS, Model GM322IF, K032719).

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define specific "acceptance criteria" in terms of measurable performance metrics and then report the device's achievement against these in a table format. Instead, it relies on demonstrating compliance with recognized standards and similarity to the predicate device to establish substantial equivalence.

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit)	Reported Device Performance/Evidence
Intended Use	Identical to predicate device	"The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain." This is stated as the intended use, and the submission claims it's the same as the cleared device.
Technological Characteristics	Output characteristics and controls identical to predicate device	"The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A50IF have output characteristics and controls that are identical to those of the predicate device."
Safety - Electrical & EMC	Compliance with recognized electrical safety and electromagnetic compatibility standards	"Compliance to applicable voluntary standards includes ANSI/AAMI. NS4-1985, as well as IEC 60601-1, and IEC 60601-1-2 requirement."
Software Validation	Follow FDA software guidance	"In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance."
Differences from Predicate	Changes do not affect intended use or alter fundamental scientific technology.	Differences noted: new housing design, firmware/software/operation interface change (digital to analog), maximum intensity adjustment range changed from 60mA to 70mA, operation modes reduced from 9 to 4. Conclusion: "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."

2. Sample Size Used for the Test Set and the Data Provenance

The summary does not provide details on a specific "test set" in the context of clinical or performance data for the device. The testing mentioned largely refers to engineering verification and validation against standards and comparisons to the predicate device's specifications. Thus, there is no disclosed sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical or performance "test set" in the sense of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the submission. The submission focuses on substantial equivalence through engineering changes and compliance with standards, not on clinical performance evaluated against expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As there is no clinical or performance "test set" with ground truth established by experts discussed, an adjudication method is not applicable 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a stimulator, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" or AI assistance in that context.

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

This refers to an "algorithm only" performance study, typically for AI or software-based diagnostic devices. The Gemore IF stimulator is a physical electrical stimulation device. While it has firmware/software, the primary "performance" is the electrical output. The summary indicates "software verification has been carried out according to the FDA software guidance," but this is about the software itself functioning correctly, not about a standalone clinical performance evaluation of an algorithm in the sense of AI.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically applied to diagnostic or prognostic devices is not directly applicable or detailed in this submission. The "truth" for this submission revolves around:

Compliance with engineering standards: The device's electrical output and safety features meet established international and voluntary standards (e.g., ANSI/AAMI. NS4-1985, IEC 60601-1, IEC 60601-1-2).
Verification of software functionality: The software operates according to design and FDA guidance.
Substantial equivalence to the predicate: The device's intended use and fundamental technological characteristics are equivalent to the previously cleared predicate device, despite stated modifications.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is an electrical stimulator, not a machine learning or AI-based device that would typically involve a "training set" for model development.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided. As there is no AI/ML component with a training set, the establishment of ground truth for such a set is not relevant to this submission.

Summary

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510(K) Summarv

DEC 2 1 2012

This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 on August 30, 2012.

The assigned 510(k) number is: _ K122944

Submitter 's Identifications:

Company Name :	GEMORE TECHNOLOGY CO., LTD.
Contact person:	Boden S.P. Lai
Address :	11FL., NO. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan
TEL No. :	886-2-8809-1799
Fax No. :	886-2-8809-1781
E-mail address :	boden001@gmail.com

1. Name of the Device:
  Trade/Device Name: Gemore IF True Sine Interferential Stimulator Model GM3A001F/GM3A10IF/GM3A20IF/GM3A50IF Regulation Number: Unclassified Regulation Name: Interferential Stimulator Requlatory Class: II Product Code: LIH
1. Information of the 510(k) Cleared Device (Predicate Device):
  Gemore IF TENS/Model: GM322IF(K032719).

4. Dev ice Description:

1. 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. Subst antial Equivalence Comparison

The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A501F have output characteristics and controls that are identical to those of the predicate device. The new devices were modified different from the predicate device with the following different features:

1> The new device housing was designed and constructed for each model.
2> The firmware, software and operation interface were change so as to change the operation type from digital to analog.
3.> The maximum intensity adjustment range was changed from 60mA to 70 mA.
4> The operation modes was reduced from 9 modes into 4 modes,

7. 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 IEC 60601-1, and IEC 60601-1-2 requirement.

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

8. Conclusions_

The Gemore IF true sine interferential stimulator. model GM3A00IF/GM3A10IF/GM3A20IF /GM3A50IF, has the same intended use and technological characteristics as the cleared device of GM322IF(K032719). 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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Public Health Service

December 21, 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Gemore Technology Company, Ltd. % Mr. Boden S. P. Lai General Manager 11 Fl, No. 29-5, Sec 2 Chung Cheng E. Rd Tan Shui, Taipei Hsien China (Taiwan) 25 1

Re: K122944

Trade/Device Name: Gemore IF series True sine interferential stimulator/Model GM3A00IF/GM3A10IF/GM3A20IF/GM3A50IF

Regulation Number: Unclassified Regulation Name: Interferential Stimulator Regulatory Class: Class II Product Code: LIH Dated: September 21, 2012 Received: September 24, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. Lai

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_ 1 of

次1229444 510(k) Number (if known):_

Device Name: Gemore IF series True sine interferential stimulator Model: GM3A00IF/GM3A10IF/GM3A20IF/GM3A50IF

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)

Prescription Use V OR

(Division Sign-Off)
Division of Neurological and Physical

Division of Neurological and Physical Medicine Devices 510(k) Number

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).