(160 days)
TENS: The device is designed 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.
EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. The device is designed to temporarily increase local blood circulation in healthy leg muscles.
Not Found
The provided FDA 510(k) Clearance Letter for Shenzhen Yicai Health Technology Co. Ltd's Transcutaneous Electrical Nerve Stimulator (TENS) does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML medical device.
This document is a standard clearance letter for a physical medical device (TENS/EMS) and focuses on regulatory aspects like:
- Substantial equivalence to predicate devices.
- General controls (registration, listing, GMP, labeling, misbranding).
- Quality System (QS) regulation.
- Unique Device Identification (UDI) requirements.
- Indications for Use.
It does not detail performance studies conducted to establish effectiveness or safety beyond establishing substantial equivalence to a predicate. Specifically, it lacks any mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or effect sizes for human readers.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or ground truth establishment for training.
Therefore,Based on the provided FDA 510(k) clearance letter, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested. The letter is for a physical medical device (Transcutaneous Electrical Nerve Stimulator) and outlines its regulatory clearance, not the details of a performance study, especially not one applicable to an AI/ML device as your detailed questions suggest.
The document does not contain any information related to:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
This is a clearance letter for a device whose mechanism of action is electrical stimulation, not an AI/ML algorithm. The information you are seeking would typically be found in the 510(k) summary or the full submission, which are not included in this clearance letter.
§ 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).