(28 days)
V2 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "V2 OTC Pain Relief TENS" device (K182767) does not contain the detailed information necessary to answer your request.
The letter is a standard FDA clearance document. It confirms that the device is substantially equivalent to a predicate device and outlines general regulatory provisions. It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample size, data provenance, or types of studies conducted (e.g., test set, training set).
- Information on expert establishment of ground truth, adjudication methods, or MRMC studies.
- Specifics on standalone algorithm performance or the type of ground truth used.
For a medical device like a TENS unit, the primary "study" proving it meets acceptance criteria for substantial equivalence typically involves demonstrating that its technological characteristics (e.g., electrical stimulation parameters, waveform, output intensity) are substantially equivalent to a legally marketed predicate device, and that it performs as intended for its indicated use (temporary pain relief). This is usually supported by:
- Bench testing: To confirm electrical output specifications.
- Performance testing: To ensure it functions as described.
- Biocompatibility testing: If applicable, for patient contact materials.
- Electrical safety and EMC testing: To comply with relevant standards.
The letter itself does not detail these specific tests or their results, nor does it refer to studies involving AI, image analysis, or complex algorithms that would require the kind of detailed information about ground truth, expert consensus, MRMC studies, or training/test sets that you are asking for. Your questions are highly relevant for AI/ML-based medical devices, but this document pertains to a traditional electrical stimulation device for pain relief.
Therefore, I cannot populate the table or answer the specific questions about the study design using the provided text.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).