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The Self-adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.

The Self-adhesive electrode, lead wire type and snap button type, are non-sterile flexible structures, composed of materials commonly used in this application:
First layer: Non-woven fabric tape
Second layer: Polyurethane (PU) electrically conductive carbon cloth (Hebei Kangshengda Electronic Technology Co., Ltd)
Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified in ISO 10993-5.
The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Self-adhesive Electrode" (K213879), structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list "acceptance criteria" for each parameter in the way a formal study report might. Instead, it demonstrates substantial equivalence to a predicate device (K090198) by comparing various characteristics and reporting that the new device met specific test standards or manufacturer requirements.

The table below presents the comparative data and implies the "acceptance criteria" are generally that the new device's performance is similar to or meets the standards met by the predicate device, or adheres to established industry standards for such devices.

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

The document does not specify a separate "test set" in terms of patient data. The evaluation relies on non-clinical bench tests performed on the "Self-adhesive Electrode" device itself.

• Sample Size: The document does not explicitly state the number of electrodes tested for each bench test. For example, it lists "Impedance test," "Conformability test," "Fluid tolerance test," "Peeling force test," and "Simulation use test" but doesn't provide the quantity of devices subjected to these tests.
• Data Provenance: The tests were "Bench tests" conducted on the proposed device. The country of origin for the device manufacturer is China (Bozhou Rongjian Medical Appliance Co.,Ltd., Anhui, China). The data is retrospective in the sense that these tests were completed before the 510(k) submission.

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

This information is not applicable as the study did not involve human interpretation or a "ground truth" derived from expert consensus on clinical data. The tests performed were objective bench tests against established standards and comparative measurements.

4. Adjudication Method for the Test Set

This is not applicable as there was no test set involving subjective human assessment or consensus building. The assessments were based on direct measurements and compliance with technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data was not including in this submission."

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done

This is not applicable. The device is a self-adhesive electrode, a physical medical device, not an algorithm or software. Therefore, an "algorithm only" performance study is irrelevant. The compliance for the device involves physical and electrical characteristics.

7. The Type of Ground Truth Used

For this device, the "ground truth" or reference for performance and safety is established by:

• Established industry standards: Such as ISO 10993 series for biocompatibility, AAMI/ANSI ES 60601-1, and IEC 60601-2-2 for electrical safety and performance.
• Manufacturer's internal requirements: For tests like peeling force and simulation use.
• Predicate device characteristics: Demonstrating that the new device's properties (materials, dimensions, electrical impedance ranges) are similar to those of a legally marketed predicate device (K090198).

There is no clinical ground truth (e.g., pathology, outcomes data) as no clinical study was performed.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable for the same reason as point 8.

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