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ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only.

ELECTRODES PAD transmit electrical current to patient skin, the electrical current is first transmitted via the snap button or lead wire then transmitted to the conductive hydrogel which is adhered to patient skin. ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only. And the PAD is designed for single-patient and multiple application use. The leadwire type electrode and snap type electrode both have six basic components. Both models are composed of an insulation backing layer, a double sides adhesive tape, conducting film, hydrogel and plastic film. The construction different between both is leadwire and snap.

The provided document is a 510(k) Pre-market Notification for the "ELECTRODES PAD" device. It describes the device, its intended use, and its comparison to predicate devices, along with performance data.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for the non-clinical tests (biocompatibility, adhesion, dispersion, shelf life, electrical safety). The nature of these tests (e.g., in-vitro for cytotoxicity, potentially animal or human for irritation/sensitization, accelerated aging for shelf life) implies a controlled testing environment, but details are not provided. The data provenance is derived from the performance testing conducted by the manufacturer, Shenzhen Bestpad Technology Development Co., Ltd. The document does not specify country of origin for the data beyond the manufacturer's location in Shenzhen, China. These studies are retrospective in the sense that they are conducted on manufactured samples for regulatory submission rather than as a prospective clinical trial.

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

This information is not applicable/not provided in the context of this 510(k) submission. The performance testing described (biocompatibility, electrical impedance, adhesion, shelf life, etc.) are objective, laboratory-based tests. They rely on established industry standards and test methods (e.g., ISO 10993, AAMI EC 12, IEC 60601-1, ASTM F1980) rather than expert consensus or ground truth derived from expert review of subjective data. There is no mention of human experts evaluating results for these specific performance criteria.

4. Adjudication Method for the Test Set

This is not applicable/not provided. As the acceptance criteria are based on objective, quantifiable measures from laboratory testing (e.g., numerical thresholds for impedance, time duration for adhesion, pass/fail for biocompatibility), there is no need for an adjudication method by human experts. The results are typically compared directly against the predefined standards.

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 is not applicable. The device is an "ELECTRODES PAD," a passive medical device intended to transmit electrical current. It does not involve any artificial intelligence (AI) or machine learning components, nor does it require human readers to interpret output from the device. Therefore, an MRMC comparative effectiveness study with AI assistance is not relevant to this submission.

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

This is not applicable. As stated above, the device is a passive electrical electrode pad and does not contain any algorithms or AI components.

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

The "ground truth" for the performance criteria in this submission is the objective outcome of standardized laboratory tests and compliance with recognized industry standards. For instance:

• For biocompatibility, the ground truth is the absence of toxic effects, irritation, or sensitization as defined by ISO 10993.
• For electrical impedance, the ground truth is a reading below a specified ohmic value (< 300 ohms).
• For adhesion, the ground truth is maintaining adhesion for a defined duration and number of uses according to AAMI EC 12.
• For shelf life, the ground truth is maintaining material properties and performance after accelerated aging or real-time studies, as per relevant FDA guidance and ASTM F1980.

There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for these technical performance aspects.

8. The Sample Size for the Training Set

This is not applicable. The device is not an algorithm-based or AI-driven device, so there is no "training set" in the context of machine learning. The device's performance is based on its physical and electrical properties, tested through non-clinical methods.

9. How the Ground Truth for the Training Set was established

This is not applicable for the same reason as point 8. There is no training set for this type of device.

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