The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications. It is for OTC (Over-The -Counter) or Prescription use and is to be used for adults only.

Device Description

The Adhesive Electrodes transmit electrical current to patient skin, the electrical current is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin. Adhesive Electrodes are multi-layer reusable, flexible structures, composed of laminated materials commonly used in this application: EVA foam First layer: Insulating backing material: Second layer: Conductive film: Carbon film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET. The dimension of the adhesive electrode is 40 mm (L) × 70 mm (W) ×3mm (H).

AI/ML Overview

The provided text describes ShenZhen Quality Medical Technology Co.,Ltd's "Adhesive Electrodes" (K171381) and indicates its substantial equivalence to predicate devices, rather than outlining a detailed study proving the device meets specific acceptance criteria in the manner requested. The document is a 510(k) summary for a medical device focusing on establishing substantial equivalence to previously cleared devices.

Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.

Here's what can be extracted and inferred based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

According to the document, the acceptance criteria are largely based on equivalence to predicate devices and adherence to relevant ISO standards.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance	Remark on Equivalence
Intended Use	Transmit electrical current for TENS and EMS, OTC/Prescription, adults only. Similar to predicate devices.	The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS and EMS applications. It is for OTC or Prescription use and is to be used for adults only.	SE (Substantial Equivalence)
Material/Design	Three layers: Insulating backing, Conductive film, Conductive hydrogel. Similar in principle to predicates.	Three layers: EVA foam (insulation), Carbon film (conductive), Biocompatible self-adhesive conductive hydrogel.	SE (Substantial Equivalence)
Electrical Performance	A.C. Impedance <300 ohms	<300 ohms	SE (Substantial Equivalence)
Biocompatibility	Compliance with ISO10993-5 (cytotoxicity) and ISO10993-10 (sensitization/irritation). Similar to predicates.	All user directly contacting materials are in compliance with ISO10993-5 and ISO10993-10 requirements.	SE (Substantial Equivalence)
Electrode Performance	Electrical Impedance Performance, Adhesive Performance, Current dispersion, Peel force.	Evaluated through these tests. Tested results satisfy the requirements.	Implied to meet, based on "as safe, as effective" conclusion.
Reuse Testing	N/A (implied to meet requirements for reusable device)	Evaluated through reuse testing. Tested results satisfy the requirements.	Implied to meet, based on "as safe, as effective" conclusion.
Shelf Life	According to ASTM F1980 - 16	Conducted. Tested results satisfy the requirements.	Implied to meet, based on "as safe, as effective" conclusion.
Non-clinical Tests	Demonstrated safety, effectiveness, and performance as well as legally marketed predicate devices.	The non-clinical tests demonstrated that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.	SE (Substantial Equivalence)

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

Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing" and "non-clinical tests" which typically involve a number of units for various evaluations (e.g., electrical, mechanical, biocompatibility). However, the specific number of units tested for each criterion is not provided.
Data Provenance: The testing was conducted by or on behalf of ShenZhen Quality Medical Technology Co.,Ltd, which is based in Shenzhen, Guangdong, China. This indicates the testing was likely performed in China. The data is retrospective in the sense that it supports a regulatory submission for a device designed and tested prior to the submission date.

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

Not Applicable. This device is an adhesive electrode, and the testing described is primarily physical, electrical, and biocompatibility testing. It does not involve interpretation of medical images or data by human experts for establishing ground truth as would be relevant for diagnostic AI/CAD devices. The "ground truth" here is the objective measurement against established standards or predicate device performance.

4. Adjudication method for the test set

Not Applicable. As per point 3, there's no "ground truth" established by human interpretation that would require an adjudication method.

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/CAD/diagnostic device. No MRMC study was conducted or is relevant for this type of medical device (adhesive electrodes).

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

Not Applicable. This is a hardware medical device (adhesive electrodes). There is no algorithm in the traditional sense that would have a "standalone" performance. The performance is purely that of the physical device.

7. The type of ground truth used

The "ground truth" for the device's performance is established by objective measurements against recognized industry standards (e.g., ISO, ASTM) and comparison to the performance characteristics of legally marketed predicate devices. For example, "A.C. Impedance <300 ohms" is a measurable standard. Biocompatibility is assessed against ISO 10993.

8. The sample size for the training set

Not Applicable. This device is not an AI/machine learning device; hence, there is no "training set."

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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December 13, 2017

ShenZhen Quality Medical Technology Co.,Ltd % Jet Li Regulation Manager Guangzhou LETA Testing Technology Co., Ltd 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou. Guangdong, CN

Re: K171381

Trade/Device Name: Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: October 28, 2017 Received: November 6, 2017

Dear Jet Li:

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.

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

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801); medical device 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171381

Device Name Adhesive Electrodes

Indications for Use (Describe)

The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulations. It is for OTC (Over-The -Counter) or Prescription use and is to be used for adults only.

Type of Use (Select one or both, as applicable)

|X | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Date of the summary prepared: December 11, 2017

2. Submitter's Information

Sponsor:

510(k) Owner's Name: ShenZhen Quality Medical Technology Co.,Ltd

Establishment Registration Number: N/A

Address: 5/F, Plant C3, No.1, Nuclear Power Industrial Zone, Guanlan Shijing

Community,

Guanlan Street, Longhua New Area, Shenzhen, Guangdong

Phone: +86(755)29016583

Fax: +86(755)29016583

Contact Person: Grace Zhao

E-mail: qd0755@163.com

Application Correspondent:

Guangzhou LETA Testing Technology Co., Ltd. Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou

City.China

Contact Person: Mr. Jet Li Tile: Regulation Manager Tel: +86-18588874857 Email: med-jl@foxmail.com

3. Subject Device Information

Adhesive Electrodes Trade Name: �
Cutaneous electrode Common Name: �

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Classification name: Electrode, Cutaneous �
� Review Panel: Neurology
Product Code: GXY �
Regulation Class: ll �
Regulation Number: 882.1320 �

4. Predicate Device Information

Predicate Device 1

Sponsor	Wandy Rubber Industrial Co., Ltd
Device Name	Wandy Self-adhesive Electrodes
510(k) Number	K132998
Product Code	GXY
Regulation Number	882.1320
Regulation Class	2

Predicate Device 2

Sponsor	GMDASZ Manufacturing Co., Ltd
Device Name	Adhesive Electrodes
510(k) Number	K160138
Product Code	GXY
Regulation Number	882.1320
Regulation Class	2

5. Device Description

Adhesive Electrodes are multi-layer reusable, flexible structures, composed of laminated materials commonly used in this application:

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EVA foam First layer: Insulating backing material: Second layer: Conductive film: Carbon film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET

The dimension of the adhesive electrode is 40 mm (L) × 70 mm (W) ×3mm (H).

6. Intended Use / Indications for Use

7. Bench Testing (Non-clinical)

Compare to primary predicate devices specified in K132998 and K160138, our device and the predicate devices are same in, raw materials, physical features, and same manufacturing processes. The biocompatibility performance equivalence evidence of proposed electrode can be demonstrated according to ISO10993-1, ISO10993-5 and ISO10993-10.

The proposed Electrode evaluated through Electrode Performance testing (Electrical Impedance Performance, Adhesive Performance, Current dispersion and Peel force ), Biocompatibility testing and Reuse testing.

The non-clinical tests demonstrated that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.

8. Clinical Test Conclusion

No clinical study is needed to be included in this submission.

9. Test Summary

Sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified in ISO 10993-5.

ISO 14971:2007 Medical Device, Harm Control Application to Medical Device Shelf life testing according to FDA recognized standard ASTM F1980 - 16 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices)

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10. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Electrode piece is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

ElementsofComparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
Characteristics
Device Name andModel	Adhesive Electrodes	Wandy Self-adhesiveElectrodes	AdhesiveElectrodes	--
510 (K) Number	Applying	K132998	K160138	--
Intended Use	The AdhesiveElectrodes areintended to transmitelectrical current topatient skin for TENS(TranscutaneousElectrical NerveStimulation) andEMS (ElectricalMuscular Stimulation)applications. It is forOTC (Over-The-Counter) orPrescription use andis to be used foradults only.	Wandy Self-adhesiveElectrode is intended totransmit electrical currentto patient skin forTENS (TranscutaneousElectrical NerveStimulation) and EMS(Electrical MuscularStimulation) applications,for OTC (Over-The-Counter) or Prescriptionuse. The Electrodeare used for adults only.	The adhesiveelectrodesare intended for as areusable, conductiveadhesive interfacebetweenthe patient's skin andthemarketed electricalstimulators (i.e.TENS(TranscutaneousElectricalNerve Stimulation),EMS(Electrical MuscularStimulation), IF(Interferential) orPGF(Pulsed GalvanicStimulation) fortransmitting electricalcurrent. Theelectrode isfor OTC (Over-The-Counter) or	SE
ElementsofComparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
Product Code	GXY	GXY	GXYPrescription use.	SE
RegulationNumber	882.1320	882.1320	882.1320	SE
OTC orPrescription	OTC and Prescription	OTC and Prescription	OTC andPrescription	SE
Intended patientpopulation	adults	adults	--	SE
Single Patient Use	Single Patient Use	Single Patient Use	Single Patient Use	SE
Reusable	Reusable	Reusable	Reusable	SE
Design Feature	Three layers:1. Insulation backingmaterial: EVA foam2. Conductive film:Carbon film3.Conductivehydrogel	Three layers:1. Insulating backingmaterial: WovenFabric/Foam2. Conductor:Aluminum/Carbon3. Conductive hydrogel	Three layers:1. Insulation backingmaterial:Fabric/Foam/Tanfabric2. Conductive film:Carbon film/Carbonfilm coated withsilver/Aluminum foilfilm3. Conductivehydrogel	SE
Protective Liner	PET	PET	PET	SE
ElectricalConnection	Snap button	Snap button or lead wire	Snap button or leadwire	SE
Non-sterile	Non-sterile	Non-sterile	Non-sterile	SE
Reusable	Reusable	Reusable	Reusable	SE
A.C. Impedance	<300 ohms	<300 ohms	<300 ohms	SE
Biocompatibility	All user directlycontacting materialsare compliance with	All user directlycontacting materials arecompliancewith	Has passed therequired skinsensitivity testing	SE
Elements ofComparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
	ISO10993-5 andISO10993-10requirements.	ISO10993-5 andISO10993-10requirements.	criteria asspecified in theTripartiteBiocompatibilityGuidance for MedicalDevices and ISO10993-1requirements for skincontact. These testsinclude Cytotoxicity,Sensitization andPrimary Skin IrritationTests.

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Finial Conclusion:

Based on the indication for use, technology characteristics, and performance testing, the proposed device has been shown to be appropriate for its indication for use and is considered to be substantially equivalent to the primary predicate device and reference device.

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).