The Well Life Self Adhesive Electrode / CM, FA, PU and SP series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Well Life Self Adhesive Electrode / AP, CM, FA, PU and SP series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).

Device Description

Well Life Self Adhesive Electrode / CM, FA, PU, and SP series are non-sterile, disposable laminated, flexible structures composed of the following three main construction layers: First Layer – the exterior layer which may be made of the following different type of material coated with adhesive : white fabric(CM), white foam(FA), printed plastic film(PU) or silicon pad(SP). Second Layer - Conductive plastic film. Third Layer – Biocompatible conductive hydrogel coupling media. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation and muscle-stimulation devices. For the electrical connection, Well Life provides two different types: 1 > Snap Series Snap connection 1.65" standard size of mail. Snap is provided to connect to the wire female snap. 2> Wire Series Lead wire assembly 4.5" ~ 6" wire with .080 in. diameter female socket connected to one side of the wire.

AI/ML Overview

The provided text describes the submission for a 510(k) premarket notification for the "Well Life Self Adhesive Electrode / CM, FA, PU, and SP series." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a novel device that requires extensive clinical studies with new acceptance criteria.

Therefore, many of the requested points regarding acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not explicitly present in this type of submission. This is typical for a 510(k) for a Class II medical device where substantial equivalence is demonstrated primarily through technological characteristics and adherence to recognized performance standards and biocompatibility tests.

Here's an analysis of what information is available from the provided text, structured as per your request, explaining why certain points are not found:

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

Acceptance Criteria Category	Specific Criteria/Standard Adhered To	Reported Device Performance/Compliance
Biocompatibility	Skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 for skin contact.	Device uses Axelgaard gel (K983741, K000947) or other alternative biocompatibility material with ISO-10993 conformity certificate, all of which "have passed the required skin sensitivity testing criteria."
Electrical Performance	ANSI/AAMI EC12 (Performance Standard for Disposable ECG Electrodes)	"Conducted and completed the electrical safety testing according to the chosen performance standard, ANSI/AAMI EC12."
Substantial Equivalence	Demonstrated equivalence to predicate device K062675 (Gemore Technology Co., Ltd) in physical and technical characteristics.	Considered "as safe and effective as the predicate devices."

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 the device itself. The submission relies on the pre-existing qualification of the Axelgaard gel and the adherence to an electrical performance standard (ANSI/AAMI EC12). The sample size, provenance, and study design for proving the biocompatibility of the gel or for the electrical standard's development are not detailed in this submission. This is because the component (Axelgaard gel) itself was already cleared in other 510(k)s (K983741 and K000947).

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

Not applicable in this context. For a 510(k) submission based on substantial equivalence to a predicate device and adherence to industry standards, "ground truth" as established by medical experts for a diagnostic or AI device is not typically required or presented. The "ground truth" here would be the validated performance of the materials used and the adherence to technical standards.

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

Not applicable in this context. Adjudication methods are relevant for studies involving subjective interpretation of data (e.g., medical images) by multiple human readers, often used to establish a robust ground truth for AI model development or evaluation. This is not the type of study presented 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 MRMC study was done or is relevant. This type of study assesses the impact of AI assistance on human reader performance, which is not applicable to a self-adhesive electrode.

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

Not applicable. This device is an electrode, not an algorithm. Therefore, "standalone algorithm performance" is not a concept that applies.

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

The "ground truth" in this submission is indirectly established by:
- Prior regulatory clearance: The use of Axelgaard gel, which has already been proven suitable through previous 510(k) clearances (K983741 and K000947).
- Standardized testing: Compliance with the requirements of the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 for skin contact and ANSI/AAMI EC12 for electrical performance. The ground truth essentially relies on the validity and acceptance of these established standards and guidelines.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device and submission. This device is not an AI algorithm.

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

Summary

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K082065

510(K) SUMMARY

APR 1 0 2009

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:

1. Submitter's Identifications:

Company Name:	Well Life Healthcare Limited
Contact person:	Jenny Hsieh
Address:	1FL., No.16, Lane 454, Jungjeng Rd., Yunghe City, Taipei County, Taiwan, R.O.C.
TEL No.:	886-2-2928-2112
Fax No.:	886-2-2928-1880
E-mail address:	jenny@welllifehealthcare.com.tw

Date of Summary Preparation: July 14, 2008.

1. Device Identification:
  Classification Name: Electrode, Cutaneous

Trade/Proprietary Name: Well Life Self Adhesive Electrode / CM, FA, PU, and SP series Predicate devices: K062675 (Gemore Technology Co., Ltd)

3. Device Description

Well Life Self Adhesive Electrode / CM, FA, PU, and SP series are non-sterile, disposable laminated, flexible structures composed of the following three main construction layers:

First Layer – the exterior layer which may be made of the following different type of material coated with adhesive : white fabric(CM), white foam(FA), printed plastic film(PU) or silicon pad(SP).

Second Layer - Conductive plastic film.

Third Layer – Biocompatible conductive hydrogel coupling media

The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation and muscle-stimulation devices.

For the electrical connection, Well Life provides two different types:

1 > Snap Series Snap connection 1.65" standard size of mail. Snap is provided to connect to the wire female snap.
2> Wire Series Lead wire assembly 4.5" ~ 6" wire with .080 in. diameter female socket connected to one side of the wire.

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Predicate Technological Characteristics Comparison: ধ

Well Life Self Adhesive Electrode / CM, FA, PU, and SP series are technologically equivalent to the predicate devices. They are physically and technically similar to the those currently being marketed for "Neurostimulation" i.e., TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).

Since currently the above mentioned devices (TENS & EMS) are capable of being sold as both prescription and OTC medical device, we claimed that our electrodes are capable of being sold at both prescription and OTC TENS and EMS device application so as to fit that marketing requirement.

5. Safety and Effectiveness:

Well Life Self Adhesive Electrode / CM, FA, PU, and SP series are as safe and effective as the K062675 (Gemore Technology Co., Ltd) which was previously found to be substantially equivalent to the 510(K) cleared models via 510(k) Premarket Notifications.

The first safety issue consideration is whether or not the skin contact gel, which is used to adhere the electrode to the skin to transfer the electric current to the use patient, would cause any skin irritation. To ensure the conformity of this biocompatibility issue, we use the Axelgaard gel which has been proved suitable for the use in the skin contact part for the Axelgaard 510(K) cleared electrode with 510(K) number K983741 and K000947. or the other alternative biocompatibility material with ISO-10993 conformity certificate. All of them have passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact.

For the electricity performance, we have conducted and completed the electrical safety testing according to the chosen performance standard, ANSI/AAMI EC12. The testing report was included in this submission.

6. Conclusion:

Based upon the above mention. Well Life considers its Self Adhesive electrodes to be as safe and effective as the predicate devices being marketed and manufactured by: K062675 (Gemore Technology Co., Ltd).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Well-Life Healthcare Ltd. % Ms. Jenny Hsieh 1 FL, No. 16, Lane 454 Jungjeng Rd. Yunghe City, Taipei County Taiwan, R.O.C

APR 1 0 2009

Re: K082065

Trade/Device Name: Well-Life Self Adhesive Electrodes/CM, FA, PU, and SP models Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 7, 2009 Received: March 9, 2009

Dear Ms. Hsieh:

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 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.

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Page 2 - Ms. Jenny Hsieh

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millhiser

. Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known):

Device Name: Well Life Self Adhesive Electrode / CM, FA, PU and SP series

Indications For Use:

Prescription Use v (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of DRH, Office of Device Evaluation (ODE)

(Divis n Sign-Off) Division of Ceneral, Restorative, and Neurological Devices

0(k) Number K082063

Page 1 of

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).