The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

Device Description

The adhesive electrode is placed onto human skin and connected with electrical stimulators by lead wires. The electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.

AI/ML Overview

This document, a 510(k) Premarket Notification from the FDA, deals with an adhesive electrode and aims to prove its substantial equivalence to a predicate device, not an AI/ML-based medical device. Therefore, the information typically required for describing acceptance criteria and a study proving an AI/ML device's performance (like AUC, sensitivity, specificity, human reader improvement, ground truth establishment methods, and sample sizes for training/test sets) is not present in this document.

The document focuses on the physical and material characteristics and biocompatibility of the adhesive electrode.

Here's a breakdown of what is available and why the requested information for AI/ML devices is not applicable:

Product: Adhesive Electrode (a physical, non-AI medical device)
Purpose of Document: 510(k) Premarket Notification to demonstrate substantial equivalence to a legally marketed predicate device.

Why the requested AI/ML-specific information is not in this document:

AI/ML Performance Metrics: The performance of an adhesive electrode is not measured by metrics like AUC, sensitivity, or specificity, nor does it assist human readers in interpretation. Its performance is based on physical properties, biocompatibility, and electrical conductivity.
Training/Test Sets: There is no AI model to be trained or tested in terms of image analysis or diagnostic accuracy.
Experts/Adjudication for Ground Truth: No diagnostic interpretations are being made by the device that would require human expert consensus or adjudication to establish ground truth.
MRMC Study: There's no human-in-the-loop component for the device's function that would necessitate a Most-Relevant-Multi-Case (MRMC) study.
Standalone Performance: The device itself is a component in a larger system (electrical stimulation) and doesn't have "standalone performance" in the AI sense.
Ground Truth Type: Ground truth for this device relates to material safety, electrical properties, and physical integrity, not diagnostic accuracy based on pathology or outcomes data.

However, I can extract the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this specific non-AI device as presented in the document.

The "acceptance criteria" here relate to demonstrating the device's safety and effectiveness compared to a predicate device through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI Context):

Acceptance Criterion (Implicitly from Equivalence Claim)	Reported Device Performance (Subject Device)	Discussion/Conclusion from Document
Intended Use Equivalence: Same as predicate device.	"The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation)." (Matches predicate)	Substantially equivalent
Technological Characteristics Equivalence: Similar materials, design, and dimensions as predicate device, not raising new questions of safety/effectiveness.	Surface Area: Various rectangular and circular dimensions (listed extensively). Some overlap but also broader range than predicate's largest/smallest listed.	Substantially equivalent. "The surface area of the device does not alter its intended use."
	Components: Substrate/Wire/Hydrogel/Scrim/Conductive Fiber/Carbon conductive film/Liner	Identical to predicate.
	Materials: Non-woven Fabric + Adhesive, Wire and Terminal coated PVC, Hydrogel, PET Fabric, Carbon fiber + Reinforcing fiber, Poly-isobutylene, Carbon Black, Graphite, Additives	Identical for many, Substantially equivalent for Poly-isobutylene (predicate listed "Carbon...Black").
Biocompatibility: Comply with ISO 10993 series.	"Comply with ISO 10993 series"	Identical to predicate.
Sterility: Non-sterile.	"Non-sterile"	Identical to predicate.
Re-usability: For single patient use.	"For single patient"	Identical to predicate.
Shelf Life: Adequate shelf life demonstrated.	"3 years"	Substantially equivalent (predicate listed "2 years"). Longer shelf life implies no new safety/effectiveness concerns.
Electrical Properties: (current, charge, power densities)	Current: 58.81 mArmsCharge: 17.40 $\mu$C Power Densities: 448.32 mW/mm2	Not publicly available for predicate, so comparison is not made explicit in the table, but these values contribute to overall performance assessment.

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

Sample Size: Not specified for "functional" testing (pull test, conformability, fluid tolerance). For biocompatibility, the tests are typically performed on a limited number of samples (often 3-5) according to ISO standards, but the exact number isn't stated. Shelf-life testing involves stability studies over time, again without a stated sample size.
Data Provenance: The document is a 510(k) submission from Shaoxing Yingtuo Healthcare Co., Ltd. in China. The tests cited (Biocompatibility, Shelf life, Product performance) would have been conducted by the manufacturer or accredited labs on their behalf. The data is implicitly prospective testing done for regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. This is not an AI/ML device requiring expert interpretation of complex data (like medical images) to establish diagnostic ground truth. The "ground truth" here is compliance with safety and performance standards established by regulatory bodies (e.g., ISO, internal engineering specifications).

4. Adjudication Method for the Test Set:

Not Applicable. No human adjudication process is described or relevant for physical device testing. Test results (e.g., passing a pull force threshold, lack of irritation) are objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is specific to AI/ML systems assisting human readers in diagnostic tasks. It is not relevant for an adhesive electrode.

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

Not Applicable. This concept applies to AI algorithms. The "standalone performance" of an adhesive electrode would refer to its physical and electrical properties, which are indeed tested (e.g., pull test, electrical measurements), but not in the context of an AI algorithm operating independently of human intervention.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on established engineering standards, material science principles, and biological safety standards (e.g., ISO 10993 for biocompatibility). Performance is measured against specific thresholds (e.g., minimum pull force, maximum electrical impedance, absence of cytotoxic/irritation/sensitization response).

8. The Sample Size for the Training Set:

Not Applicable. There is no "training set" as this is not an AI/ML device.

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

Not Applicable. No training set exists.

In summary: The provided document is for a traditional medical device (an adhesive electrode) and therefore lacks the specific details related to AI/ML device validation that your questions are designed to elicit. The "study" mentioned refers to non-clinical laboratory testing (biocompatibility, shelf life, product performance) to demonstrate equivalence to a predicate device, as opposed to clinical AI algorithm validation.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

August 31, 2021

Shaoxing Yingtuo Healthcare Co., Ltd. Haze XU Management Representative, Quality Department NO.176 Shungeng Road, Baiguan Street, Shangyu Area Shaoxing City, Zhejiang Province 312300 China

Re: K210448

Trade/Device Name: adhesive electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: July 29, 2021 Received: August 5, 2021

Dear Haze XU:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Heather L. Dean -S

Heather Dean, PhD Assistant Director. Acute Injurv Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210448

Device Name adhesive electrode

Indications for Use (Describe)

The proposed device is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulator, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over The Counter Use (21 CFR 801 Subpart C)

||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

I Submitter

510(K) Number:	K210448
Device submitter:	Shaoxing Yingtuo Healthcare Co.,Ltd.
	NO.176 Shungeng Road, Baiguan Street, ShangyuArea, Shaoxing City, Zhejiang Province, P.R. CHINA.

Contact person: Haze XU Phone:+86 13735374377 E-mail: haze@sxyingtuo.com

II Device

Trade Name of Device: adhesive electrode Common name: Cutaneous Electrode Classification: Class II, 21 CFR 882.1320 Product Code: GXY

III Predicate Device

Trade name:	TENS Electrodes
Common name:	Cutaneous Electrode
Classification:	Class II, 21 CFR 882.1320
Product Code:	GXY
Premarket Notification:	K160081
Company name:	CATHAY MANUFACTURING CORP

IV Device description

V Indications for use

VI Comparison of technological characteristics with the predicate devices

The adhesive electrode has the same intended use and principle operation, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the adhesive electrode and predicate devices do not alter suitability of the proposed device for its intended use.

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	adhesive electrode(subject device)	TENS ElectrodesK160081 (predicate device)	Discussion
Device feature	(subject device)	K160081 (predicate device)	Discussion
Intended use	The proposed device is intended foruse as the disposable, conductiveadhesive interface between thepatient's skin and the electricalstimulator to apply electricalstimulation current, and is intendedto be used with marketed electricalstimulators, i.e. TENS(Transcutaneous Electrical NerveStimulation) and EMS (ElectricalMuscular Stimulation).	The proposed device isintended for use as thedisposable, conductiveadhesive interface betweenthe patient's skin and theelectrical stimulator to applyelectrical stimulationcurrent, and is intended to beused with marketed electricalstimulators, i.e. TENS(Transcutaneous ElectricalNerve Stimulation) and EMS(Electrical MuscularStimulation). It's for OTCuse	Substantiallyequivalent.
Surface area	(Length * width):20mm40mm, 22mm22mm25mm35mm, 25mm42mm25mm60mm, 30mm40mm30mm50mm, 30mm60mm30mm70mm, 32mm32mm40mm40mm, 40mm50mm40mm60mm, 40mm70mm40mm80mm, 40mm90mm40mm100mm, 40mm110mm,40mm120mm, 40mm130mm,45mm45mm, 45mm55mm45mm60mm, 45mm70mm45mm80mm, 45mm90mm45mm100mm, 48mm48mm48mm86mm, 50mm50mm50mm60mm, 50mm70mm50mm80mm, 50mm90mm50mm100mm, 50mm110mm50mm120mm, 50mm130mm55mm55mm, 55mm65mm55mm70mm, 55mm75mm55mm80mm, 55mm90mm55mm100mm, 55mm110mm	Largest model:CM100180FC (Rectangleshape: 100 x 180 mm);Smallest model:CM2222FC(square shape: 22x 22 mm);Irregular representative:CM2542YC(crescent );	Substantiallyequivalent.Thesurface area ofthe device doesnotalteritsintended use.
	adhesive electrode(subject device)	TENS ElectrodesK160081 (predicate device)	Discussion
Device feature	55mm120mm, 55mm130mm60mm60mm, 60mm70mm60mm80mm, 60mm90mm60mm100mm, 60mm110mm60mm120mm, 60mm130mm65mm65mm, 70mm70mm70mm80mm, 70mm90mm70mm100mm, 70mm110mm70mm120mm, 70mm130mm75mm75mm, 75mm125mm80mm80mm, 80mm100mm80mm110mm, 80mm120mm80mm130mm, 85mm85mm85mm180mm, 90mm90mm90mm120mm, 90mm130mm100mm120mm, 100mm125mm100mm130mm, 100mm140mm100mm180mm, 105mm155mm124mm*130mm.
	(Diameter):22mm, 25mm, 32mm, 40mm,45mm, 50mm, 55mm, 60mm,65mm, 70mm, 75mm, 80mm,85mm, 90mm
Components	Substrate/Wire/Hydrogel/Scrim/Conductive Fiber/Carbon conductive film/Liner	Substrate/Wire/Hydro-gel/Scrim/ConductiveFiber/Carbon conductive film/Liner	Identical
Materials	Non-woven Fabric + Adhesive	Non-woven Fabric +Adhesive	Identical
	Wire and Terminal coated PVC	Wire and Terminal coatedPVC	Identical
	Hydrogel	Hydro-gel	Identical
	PET Fabric	PET Fabric	Identical
	Carbon fiber + Reinforcing fiber	Carbon fiber + Reinforcingfiber	Identical
	Poly-isobutylene, Carbon Black	Poly-isobutylene, Carbon...	Substantially
Device feature	adhesive electrode(subject device)	TENS ElectrodesK160081 (predicate device)	Discussion
	Graphite, Additives	Black	equivalent.
Current(mArms)	58.81	Not Publicly Available	/
Charge( $ \mu $ C)	17.40	Not Publicly Available	/
powerdensities(mW/mm2)	448.32	Not Publicly Available	/
Biocompatibility	Comply with ISO 10993 series	Comply with ISO 10993 series	Identical
Sterility	Non-sterile	Non-sterile	Identical
Re-usable	For single patient	For single patient	Identical
Shelf life	3 years	2 years	Substantiallyequivalent.

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VII Summary of Non-clinical tests:

Biocompatibility testing

Biocompatibility of the adhesive electrode was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface-contacting devices: Skin" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation and Sensitization. All evaluation acceptance criteria were met.

Shelf life testing

The shelf life of the adhesive electrode is determined based on stability study which includes ageing test.

Product performance testing

Performance testing includes pull test, conformability test, fluid tolerance testing, and Shelf-Life testing for both subject device and predicate device.

VIII Conclusion

The adhesive electrode is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed 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).