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TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

A portable TENS device for pain control.

This K984025 submission describes a TENS (Transcutaneous Electrical Nerve Stimulation) device called CARE TENS. It's important to note that this is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, rather than a de novo submission that establishes new performance criteria. Therefore, the "acceptance criteria" here are primarily based on equivalence to the predicate.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission relies on bench testing for technological comparison, not a clinical test set with patient data.
• Data Provenance: Not applicable, as no clinical data was used.

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

• Not applicable. No clinical test set with ground truth was established, as the evaluation was based on bench testing for substantial equivalence to a predicate device.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication method was used.

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 is a TENS device, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

• The device itself is a standalone TENS unit. Its "performance" was assessed by comparing its electrical output characteristics to a predicate device through bench testing. There is no "algorithm" in the context of AI being evaluated here.

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

• Not applicable in the traditional sense of clinical ground truth. The "ground truth" for the comparison was the electrical output specifications and performance characteristics of the predicate device (Matrix I, K895473), as determined through bench testing.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or AI models that require a training set.

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

• Not applicable, as there is no training set for this type of device submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the CARE TENS device meets its acceptance criteria (implicitly, substantial equivalence to the predicate) was nonclinical bench testing.

• Methodology: Bench testing was performed to compare the output characteristics of the CARE TENS to its predicate device, Matrix I (K895473). The comparison also included verifying compliance with FDA's Final Rule regarding electrode lead wires and patient cables, which was the only stated technological difference.
• Results: The bench testing demonstrated that the electrical output characteristics of the CARE TENS were "substantially equivalent" to those of the predicate device. The report concluded that any differences between the devices (specifically, the updated jacks and cables) did not raise new questions of safety and effectiveness.
• Conclusion: Based on this nonclinical testing, the FDA determined that the CARE TENS was substantially equivalent to the predicate device, allowing it to be marketed.

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