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The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications. It is for OTC (Over-The -Counter) or Prescription use and is to be used for adults only.

The Adhesive Electrodes transmit electrical current to patient skin, the electrical current is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin. Adhesive Electrodes are multi-layer reusable, flexible structures, composed of laminated materials commonly used in this application: EVA foam First layer: Insulating backing material: Second layer: Conductive film: Carbon film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET. The dimension of the adhesive electrode is 40 mm (L) × 70 mm (W) ×3mm (H).

The provided text describes ShenZhen Quality Medical Technology Co.,Ltd's "Adhesive Electrodes" (K171381) and indicates its substantial equivalence to predicate devices, rather than outlining a detailed study proving the device meets specific acceptance criteria in the manner requested. The document is a 510(k) summary for a medical device focusing on establishing substantial equivalence to previously cleared devices.

Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.

Here's what can be extracted and inferred based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

According to the document, the acceptance criteria are largely based on equivalence to predicate devices and adherence to relevant ISO standards.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing" and "non-clinical tests" which typically involve a number of units for various evaluations (e.g., electrical, mechanical, biocompatibility). However, the specific number of units tested for each criterion is not provided.
• Data Provenance: The testing was conducted by or on behalf of ShenZhen Quality Medical Technology Co.,Ltd, which is based in Shenzhen, Guangdong, China. This indicates the testing was likely performed in China. The data is retrospective in the sense that it supports a regulatory submission for a device designed and tested prior to the submission date.

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

• Not Applicable. This device is an adhesive electrode, and the testing described is primarily physical, electrical, and biocompatibility testing. It does not involve interpretation of medical images or data by human experts for establishing ground truth as would be relevant for diagnostic AI/CAD devices. The "ground truth" here is the objective measurement against established standards or predicate device performance.

4. Adjudication method for the test set

• Not Applicable. As per point 3, there's no "ground truth" established by human interpretation that would require an adjudication method.

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. This is not an AI/CAD/diagnostic device. No MRMC study was conducted or is relevant for this type of medical device (adhesive electrodes).

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

• Not Applicable. This is a hardware medical device (adhesive electrodes). There is no algorithm in the traditional sense that would have a "standalone" performance. The performance is purely that of the physical device.

7. The type of ground truth used

• The "ground truth" for the device's performance is established by objective measurements against recognized industry standards (e.g., ISO, ASTM) and comparison to the performance characteristics of legally marketed predicate devices. For example, "A.C. Impedance <300 ohms" is a measurable standard. Biocompatibility is assessed against ISO 10993.

8. The sample size for the training set

• Not Applicable. This device is not an AI/machine learning device; hence, there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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