(35 days)
The XLTEK Stimulator Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
The probes are sterile and are for single patient use only.
Not Found
The provided text is a 510(k) clearance letter from the FDA to Excel-Tech Ltd for their XLTEK Stimulator Probes. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.
The document is a regulatory approval letter based on the claim of substantial equivalence, not a detailed report of a performance study. Therefore, I cannot extract the information you are looking for from this text.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.