(376 days)
The Sportstim 2.0 can only be used upon the prescription of a physician for the symptomatic relief of chronic intractable pain, including the relief of post-traumatic and post-surgical pain.
Not Found
The provided text is related to the FDA clearance of a TENS device (Sportstim Model 2.0 TENS Device, K962951). However, it does not contain any information about acceptance criteria, device performance studies, or clinical trial specifics as requested.
The document is a clearance letter stating that the device is substantially equivalent to predicate devices and can be marketed. It discusses regulatory classifications, general controls, and contact information for compliance.
Therefore, I cannot provide the requested information based on the given text. The text does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for the training set or how its ground truth was established.
This is a regulatory clearance document, not a study report or clinical evidence summary.
§ 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).