(373 days)
T.E.N.S. stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
Not Found
I am sorry, but based on the text provided, there is no information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification approval letter for the "Pain Buddy" Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, stating that the device is substantially equivalent to a legally marketed predicate device.
The document includes:
- Trade/Device Name: Pain Buddy
- Regulation Number: 21 CFR 882.5890
- Regulation Name: Transcutaneous electrical nerve stimulator for pain relief
- Regulatory Class: II
- Product Code: NUII
- K Number: K102051
- Indications for Use: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain. The device is for Over-The-Counter Use.
However, it does not contain the specific details requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of a test set.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
This document is primarily an FDA approval letter for substantial equivalence, not a detailed study report.
§ 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).