(35 days)
To locate and identify cranial motor nerves during ENT and intra-cranial procedures.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Neurosign Nerve Monitor." This document focuses on regulatory approval based on substantial equivalence to a predicate device and does not contain information about acceptance criteria, detailed study results, sample sizes, expert qualifications, or ground truth establishment that would allow me to answer your request.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the approval is based on comparison to existing devices, not necessarily a new, detailed performance study with the specific metrics you requested.
Therefore, I cannot provide the information you asked for based on the input 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.