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The model WL-2406 TENS is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The Well Life TENS devices, WL-2406 is the model of OTC TENS intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

WL-2406 is a dual channel, 3V battery operated TENS device with the following features:

• The operation mode is "Wire" with dual channels.
• The stimulation electrode is connected via electrode belt for "Wire" operation mode.
• The output waveform is selectable pre-programming changed amonq P1~P8.
• The output strength is adjustable at 0~50 mA, with setting time 21 minutes counting from switching ON.
• The LCD display is provided for the indication of operation status including operation mode. output wave form, output strength, time to cut-off, and battery low warning.

This a TENS device, and the information provided does not describe a study that uses a test set, ground truth, experts, or AI. Therefore, I will respond to the specific points based on the information available regarding non-clinical tests for medical devices.

Here's a breakdown of the acceptance criteria and how the device (WL-2406 TENS) met them, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The study that proves the device meets the acceptance criteria is described as "verification and validation tests" and a demonstration of "substantial equivalence" to a legally marketed predicate device (WL-2402, K040512).

Here's a breakdown of the requested information based on the provided text:

1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on substantial equivalence to a predicate device and compliance with voluntary standards for non-clinical testing. There is no mention of a clinical test set with patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth typically refers to clinical outcomes or expert diagnoses in a clinical study. This submission focuses on non-clinical engineering and safety standards. The "experts" involved would be the engineers and regulatory specialists performing the verification and validation tests and assessing compliance with standards like ANSI/AAMI NS4-1985, EN 60601-1, and EN 60601-1-2. Their qualifications are implicitly in their ability to conduct these standard tests.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no mention of a human-adjudicated test set in this 510(k) summary.

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: Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic or assistive technology. It does not involve human readers interpreting cases or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for pain relief, not an algorithm. The "standalone" performance refers to the device's electrical and functional parameters as measured against engineering standards.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and effectiveness is established through:

   • Compliance with recognized voluntary standards: ANSI/AAMI NS4-1985 (electrical safety), EN 60601-1 (general medical electrical equipment), and EN 60601-1-2 (electromagnetic compatibility).
   • Software verification: Though not explicitly detailed, compliance with FDA software guidance would involve verifying the software's functional requirements, design specifications, and safety measures.
   • Substantial equivalence demonstration: The primary "ground truth" for marketing clearance is that the device is "as safe and effective" as a legally marketed predicate device. This is achieved by showing that any differences in technological characteristics do not raise new questions of safety or effectiveness and that the intended use is the same.

7. The sample size for the training set: Not applicable. This device does not use machine learning or AI, so there is no "training set."

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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