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The TATUNG TMD-26AX SERIES TENS is intended for symptomatic relief and management of chronic intractable pain.

TATUNG TMD-26AX SERIES TENS Transcuntaneus Electrical Nerve Stimulation System, designed for symptomatic relief and management of chronic intractable pain. It provides a combination of four stimulant modes and good for muscular pain. The device has five preprogrammed function mode, and adjustable output intensity and stimulating rate. With large LCD panel. It is powered by three(3) AAA 1.5V Battery. TATUNG TMD-26AX SERIES TENS requires the use of a set of leadwire and one pair of cutaneous stimulation electrodes.

The provided 510(k) summary for the TATUNG TMD-26AX Series TENS does not contain specific acceptance criteria or an efficacy study demonstrating its performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device based on similar intended use, technological characteristics, and conformance to general safety and EMC standards.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not applicable. There is no mention of a clinical "test set" in the context of an efficacy study. The document refers to "bench testing" but no details on sample size for these tests are provided.
• Data Provenance: Not applicable. The submission does not detail any clinical data (either retrospective or prospective) from a specific country of origin related to the device's efficacy. The "bench testing" mentioned is likely in-house laboratory testing.

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

• Not applicable. No ground truth establishment by experts for a test set is discussed, as no efficacy study is presented.

4. Adjudication method for the test set

• Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance.

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

• Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS unit), not an AI-powered diagnostic imaging device. Therefore, MRMC studies or AI assistance for human readers are not relevant.

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

• Not applicable. This device is a TENS unit, not an algorithm. Its operation involves human interaction for placement and setting adjustments, but its "performance" is its ability to deliver electrical stimulation as intended for pain relief. The "bench testing" indirectly assessed its standalone functionality in terms of electrical output and safety.

7. The type of ground truth used

• For the "bench testing" related to safety and performance specifications: The ground truth would have been the engineering specifications and regulatory standards themselves (e.g., EN 60601-1, EN 60601-1-2, FDA output waveform requirements). The device's output and performance were compared against these pre-defined technical and safety benchmarks.
• For clinical efficacy: Not applicable, as no clinical efficacy study is presented.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of the device's function.

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

• Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the K021794 Submission Approach:

The K021794 submission for the TATUNG TMD-26AX Series TENS relies on demonstrating substantial equivalence to a previously cleared predicate device (STIMATE TENS, K003487). This approach primarily involves showing that the new device has:

• The same intended use.
• Similar technological characteristics.
• Any differences in technological characteristics do not raise new questions of safety or effectiveness.

The "bench testing" mentioned serves to support the safety and operational performance in conformance with recognized standards, thereby validating the "similar technological characteristics" claim and addressing any potential safety concerns arising from design differences. It does not involve a prospective clinical study with specific acceptance criteria for clinical efficacy.

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