(87 days)
TENS (1,2,5,8,9,10,14,15,17,18,21,22,23): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. PMS (3,4,6,7,11,12,13,16,19,20,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Not Found
The provided document is an FDA 510(k) clearance letter for a TENS & PMS Unit (Model: YF1503). It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this type of document (a 510(k) clearance letter) does NOT contain the detailed information required to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria.
510(k) clearances primarily focus on demonstrating substantial equivalence to a predicate device, based on similar intended use, technological characteristics, and safety/effectiveness data. While manufacturers submit data to support their claims, the FDA clearance letter itself does not typically include the full study design, raw performance metrics, sample sizes, ground truth establishment, or expert qualifications in the level of detail you've requested.
Therefore,Based on the provided FDA 510(k) clearance letter, I cannot provide the information requested in your prompt. This document indicates the device's clearance but does not contain the detailed study design, performance metrics, or acceptance criteria that would be found in the original submission or a separate clinical study report.
In summary, the provided text does not contain any of the following information:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Information about standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
To obtain this information, one would typically need access to the manufacturer's 510(k) submission summary, a separate clinical study report, or a labeling document if such performance claims were explicitly made.
§ 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).