(190 days)
Interferential Current Stimulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
Not Found
This document is a 510(k) clearance letter for the ETD4000 Transcutaneous Electrical Nerve Stimulator for Pain Relief. It does not contain information typically found in a study proving a device meets acceptance criteria, such as performance metrics, sample sizes, ground truth establishment, or expert qualifications.
The letter confirms that the FDA has reviewed the device and found it substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements for marketing the device and includes the "Indications for Use" for the ETD4000.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them based on the provided text. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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).