Search Results

The Mini-TENS including a series of TENS models (WL-2401, WL-2402, WL-2403, and WL-2302) is intended for symptomatic relief of chronic intractable pain.

The Mini-TENS series, including WL-2401, WL-2402, WL-2403, and WL-2302 are transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.

Mini-TENS series, models WL-2401, WL-2402, WL-2403, and WL-2302, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.

The stimulation mode for Mini-TENS is burst mode with fixed pulse rate, frequency, and fixed timer. Only amplitude is adjustable. This operation way is considered the simplification from the burst mode of comparison clear model, WL-2102A. Every model of Mini-TENS has its individual stimulation operation cycle.

The Mini-TENS series (WL-2401, WL-2402, WL-2403, and WL-2302) are almost identical in function outlook and specification.

This document describes the 510(k) summary for the Well-Life Mini-TENS series (models WL-2401, WL-2402, WL-2403, and WL-2302), which are transcutaneous electrical nerve stimulators (TENS devices). The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (Well-TENS, model WL-2102A).

This submission does not contain information related to the performance of an AI/ML device in the context of acceptance criteria from a study. It focuses on the comparison of specifications and intended use of new TENS device models against a predicate TENS device for 510(k) clearance. Therefore, a table of acceptance criteria and reported device performance isn't applicable in the context of an "AI/ML device" and a study proving it meets acceptance criteria.

However, I can extract the comparative information presented in the document, which serves as the basis for determining substantial equivalence for these medical devices.

Summary of Device Comparison and Non-Clinical Tests (as presented in the 510(k) submission):

The document presents a comparison of the new Mini-TENS series with the predicate device (WL-2102A) to demonstrate substantial equivalence. The "acceptance criteria" here implicitly refer to the notion that the new devices should not raise new questions of safety or effectiveness, and their characteristics should be comparable to or within acceptable limits relative to the predicate device and relevant standards.

Table of Performance Comparisons for Substantial Equivalence (derived from the document):

Study Information (Based on the provided document):

1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on engineering specifications comparison and compliance with voluntary standards, rather than testing on a biological "test set" with data provenance in the context of an AI/ML device. The document explicitly states: "The WL-2402 is the most complicate in these three models, so the assessment results for the features of performance and safety of this model could cover that of the other three models." This suggests a representative model was chosen for detailed assessment, but this isn't a "sample size" in the usual clinical study sense.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth from experts is not a concept used in this type of device submission, which relies on objective measurements against engineering specifications and voluntary standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set or adjudication process described.

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 is not an AI/ML device, and no MRMC study was performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. For this device, the "ground truth" or basis for acceptance is adherence to established engineering specifications, safety standards (ANSI/AAMI NS4-1985, EN 60601-1, etc.), and demonstrating that any differences from the predicate device do not raise new questions of safety or effectiveness. The device's performance is objectively measured against these defined technical criteria.

7. The sample size for the training set: Not applicable. This is not an AI/ML device and does not involve a training set.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Conclusion stated in the 510(k) Summary:

The submitter concludes that the Mini-TENS series has the "same intended use and technological characteristics as the cleared device WL-2102A. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
The engineering differences identified "do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device." This forms the basis for the FDA's substantial equivalence determination.

Ask a specific question about this device