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DL Adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

DL Adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin.

DL Adhesive Electrode is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate) or LDPE(Low Density Polyethylene).

DL Adhesive Electrode is non-sterile and intended for single adult patient multiple application use. The Adhesive Electrode has various shapes and sizes.

To connect with a nerve or muscle stimulator, DL Electrode pads have lead wire type or snap button type. The lead wires have female sockets, while the snap buttons have male connectors. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) carrier liner.

The conductive hydrogel is imported from Covidien, USA, we used the same conductive hydrogel as the Self-Adhering TENS/NMES/FES Stimulating Electrode which was 510(k) cleared with number of K100418. Further, our entire Adhesive Electrode together with the conductive hydrogel media has passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.

The provided document is a 510(k) Pre-market Notification for the DL Self-adhesive Electrode (K182111). The document describes the device, its intended use, and importantly, presents non-clinical testing to demonstrate substantial equivalence to predicate devices, thereby ensuring its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DL Adhesive Electrode are primarily based on comparisons with two predicate devices:

• Primary Predicate: K152648 - Ennova Self-adhesive Electrode
• Reference Predicate: K100418 - Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode (specifically for the conductive hydrogel)

The equivalence is demonstrated through various non-clinical (bench) tests and a direct comparison of technological characteristics.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The document explicitly states: "Clinical data was not including in this submission."
Therefore, the device's substantial equivalence is demonstrated solely through non-clinical (bench) testing and comparison of technical characteristics to legally marketed predicate devices.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in terms of number of devices tested for each standard. The document only lists the standards applied and that "Bench tests were conducted on DL Adhesive Electrode to verify that the proposed device met all design specifications."
   • Data Provenance: The tests were performed internally or by accredited labs on samples of the DL Adhesive Electrode. The data origin is thus the manufacturer's testing or contract testing facilities, likely within China (where the manufacturer is located). The provenance is prospective with respect to the regulatory submission, as these tests were conducted specifically to support this 510(k). No patient data is involved.

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

   • Not Applicable. As no clinical data was used, there was no "ground truth" derived from expert consensus on patient cases. The "ground truth" for the non-clinical tests are the specified performance limits within the referenced national and international standards (e.g., AAMI, ISO, ASTM) and the technical specifications of the predicate devices. These standards are developed by expert committees, but individual experts were not involved in establishing ground truth for a test set in the context of this submission.

3. Adjudication method for the test set:

   • Not Applicable. Since there was no clinical study involving human readers or subjective interpretations of data, an adjudication method for a test set is not relevant. The assessment relies on objective measurements against pre-defined engineering and performance criteria.

4. 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. An MRMC study was not done. This device is a passive accessory (an electrode); it does not involve AI, human-in-the-loop performance, or image interpretation.

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

   • No. This device is an electrode, not an algorithm or AI system.

6. The type of ground truth used:

   • Technical Specifications and Regulatory Standards. The ground truth for this submission is established by adherence to recognized national and international consensus standards (ASTM, ISO, AAMI/ANSI IEC) for medical electrical equipment, biocompatibility, and shelf-life, as well as direct comparison to the established performance characteristics of the legally marketed predicate devices. Key safety criteria, such as maximum power density, also refer to FDA guidance.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not a machine learning or AI device.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set was used.

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Ennova Self-adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

Ennova Self-adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. Ennova Self-adhesive Electrode is composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient(age=18) multiple application use. Ennova Self-adhesive Electrode has various shapes and sizes. To connect with a nerve or muscle stimulator, this Electrode has lead wire type and snap button type. For lead wire type electrode, the wire is at least 40mm long, with 2.0~3.5mm diameter female socket. For snap button type electrode, the connector is male snap button. The individual electrodes are electrically connected in pairs. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) release liner.

The provided text describes a 510(k) premarket notification for the Ennova Self-adhesive Electrode. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested details about a study proving device acceptance criteria cannot be extracted from this document, as a clinical study was explicitly not included in this submission.

Here's an analysis based on the information available:

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

The document doesn't define "acceptance criteria" in the traditional sense of a clinical trial's primary or secondary endpoints. Instead, it outlines design specifications and performance standards for the device and compares them to predicate devices to establish substantial equivalence.

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

• Sample Size for Test Set: Not applicable for a clinical study in this submission. The tests performed are bench tests on the physical device components. The document does not specify the number of individual electrodes or batches tested for these non-clinical evaluations.
• Data Provenance: The tests were conducted by Suzhou Ennova Electronics Technology Co., Ltd. in China ("Bench tests were conducted on the proposed Self-adhesive Electrode to verify that the proposed device met all design specifications"). The data is non-clinical, originating from laboratory testing. It is neither retrospective nor prospective in the clinical study sense.

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

• Not applicable. This submission relies on non-clinical bench testing against recognized industry standards (e.g., ASTM, ISO, AAMI/ANSI, IEC) and comparison to legally marketed predicate devices. Ground truth in the context of expert consensus (e.g., for image interpretation) is not relevant here. The "ground truth" for these tests comes from objective measurements and adherence to specified performance metrics in the standards.

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

• Not applicable. Adjudication methods are typically used in clinical studies, particularly for subjective assessments or when reconciling differing expert opinions. The tests performed here are objective bench tests.

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:

• Not applicable. This device is a self-adhesive electrode, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.

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

• Not applicable. This is a hardware component (electrode), not an algorithm.

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

• The "ground truth" for this submission is based on established industry standards (e.g., ISO, ASTM, AAMI/ANSI, IEC) and the performance characteristics of legally marketed predicate devices. For example, biocompatibility is assessed against ISO standards, and electrical performance against AAMI/ANSI and IEC standards. The efficacy is inferred from the substantial equivalence to predicate devices that have already demonstrated safety and effectiveness for their intended use.

8. The sample size for the training set:

• Not applicable. This device's approval is based on substantial equivalence demonstrated through bench testing and comparison to predicates, not through machine learning model training.

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

• Not applicable. See point 8.

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Zekang Self-Adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The-Counter) or Prescription use.

Zekang Self-adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin.

Zekang Self-adhesive Electrode is composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient multiple application use. Zekang Self-adhesive Electrode has various shapes and sizes.

To connect with a nerve or muscle stimulator, this Electrode has lead wire type and snap button type. For lead wire type electrode, the wire is at least 40mm long, with 2.0~3.5mm diameter female socket. For snap button type electrode, the connector is male snap button. The individual electrodes are electrically connected in pairs. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) release liner.

The conductive hydrogel is imported from Covidien, USA, which was 510(k) cleared with number of K100418. And the whole Zekang Self-adhesive Electrode together with the conductive hydrogel has again passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.

This document is a 510(k) summary for the "Zekang Self-Adhesive Electrode" and does not describe a study involving algorithms, human readers, or image analysis. Instead, it focuses on the substantial equivalence of a physical medical device (an electrode). Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document refers to "design specifications" and compliance with standards, but does not list specific numerical acceptance criteria values alongside corresponding device performance results in the way one might for an AI model's accuracy. Instead, it indicates successful completion of various tests deemed sufficient for substantial equivalence.

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

• This information is not provided in the document. The studies mentioned are bench tests and biocompatibility tests on the physical device, not on data.

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

• This information is not applicable as the document describes testing of a physical electrode, not data, and does not involve establishing ground truth by medical experts in the context of an AI study.

4. Adjudication Method for the Test Set

• This information is not applicable as the document describes testing of a physical electrode, not a medical image analysis or similar AI evaluation that would require adjudication.

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

• This information is not applicable. This document is for a self-adhesive electrode, not an AI or imaging device involving human reader performance.

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

• This information is not applicable. This describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• This information is not applicable in the context of AI. For the physical device, "ground truth" would be defined by the standards and specifications it's tested against (e.g., a hydrogel causing no cytotoxicity is "ground truth" for biocompatibility).

8. The Sample Size for the Training Set

• This information is not applicable as the document is about a physical device and makes no mention of AI or machine learning training sets.

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

• This information is not applicable as the document is about a physical device and makes no mention of AI or machine learning training sets.

Summary of the Document's Purpose:

The provided document is an FDA 510(k) clearance letter and summary for a "Zekang Self-Adhesive Electrode." The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is primarily done through bench testing, biocompatibility testing, and comparison of technical specifications, rather than clinical studies involving human patients or complex AI performance metrics.

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