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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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