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Self-Adhesive Electrode is intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.

Self-Adhesive Electrode are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Roundwhale are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:

1. Top layer: Fabric/Foam/ Tan fabric
2. Middle layer: Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film)
3. Bottom layer: Biocompatible self-adhesive conductive hydrogel
4. Connection: Leadwire/snap button/magnetic button
5. double sides adhesive tape: Which is used for attaching the non-woven fabrics and conducting film
6. Release film: Release film is a protective layer for the hydrogel.
   The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
   For the electrical connection, Roundwhale provides lead wire type and snap button/Magnetic button type:

• Leadwire assembly: The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer.
• Snap button/Magnetic button assembly: With 2.5~5mm diameter male socket.

This document is an FDA 510(k) summary for the Shenzhen Roundwhale Technology Co., Ltd. "Self-adhesive Electrode" device. It outlines the device's indications for use, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This document pertains to a cutaneous electrode, which is a relatively simple medical device. Therefore, the "acceptance criteria" and "study" described are focused on physical and electrical performance and biocompatibility, not on complex diagnostic accuracy metrics like those for AI-powered imaging devices (e.g., sensitivity, specificity, AUC). The request's points regarding MRMC studies, expert concensus for ground truth, and training data are typically applicable to AI/ML device submissions, which are not relevant to this electrode device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on established industry standards and comparisons to legally marketed predicate devices. The "reported device performance" demonstrates that the proposed device meets or is comparable to these criteria.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

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

   • The document does not specify exact sample sizes (e.g., number of electrodes tested) for each non-clinical test. It generally states that "The submitted sample(s) complied..." However, based on the nature of bench testing for these types of devices, standard engineering practices would involve testing multiple units to demonstrate conformity.
   • Data Provenance: The tests are "Non-Clinical Data" and "Bench Testing," implying in-house lab testing or third-party lab testing. The document does not specify country of origin for the testing itself, but the company is based in Shenzhen, China. The data is retrospective in the sense that it was generated prior to submission.

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

   • This question is not applicable to this type of device submission. For a cutaneous electrode, "ground truth" is established by direct physical, electrical, and chemical measurements against industry standards (e.g., resistance, adhesion force, material composition, cytotoxicity tests). There are no "experts" in the radiological interpretation sense involved in establishing this type of ground truth.

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

   • This question is not applicable. Adjudication methods are relevant for subjective interpretations, particularly in medical imaging or clinical trials where expert consensus resolves disagreements. For bench testing of an electrode, results are objective measurements derived from direct testing.

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:

   • This question is not applicable to this device. MRMC studies are used for AI/ML-enabled diagnostic devices where human readers (e.g., radiologists) interact with an AI system. This submission is for a physical electrode, not a diagnostic AI tool.

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

   • This question is not applicable to this device. "Standalone performance" refers to the performance of an algorithm without human intervention, typically in AI/ML diagnostic tools. This device is not an algorithm.

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

   • The "ground truth" for this device is based on industry standards and objective physical, electrical, and chemical measurements.
     • Physical/Mechanical: E.g., measured peel strength (adhesion) against a specified Newton (N) threshold, measured force to remove wires against a specified pound-force threshold.
     • Electrical: E.g., measured AC impedance against a specified ohm threshold.
     • Biocompatibility: Results of specific ISO 10993 tests (Cytotoxicity, Skin Sensitization, Skin Irritation) which have defined pass/fail criteria based on biological reactions.
     • Safety/EMC: Compliance with well-defined performance requirements in standards like ES60601-1 and IEC 60601-2-2.

7. The sample size for the training set:

   • This question is not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

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

   • This question is not applicable for the same reason as above; there is no training set.

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