(202 days)
To locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots.
Neurosign 800. 8 Channel Motor Nerve Monitor
This document is an FDA 510(k) clearance letter for the Neurosign 800, 8 Channel Motor Nerve Monitor, dated August 5, 1998. The letter states that the device is substantially equivalent to legally marketed predicate devices. However, this type of regulatory correspondence does not contain the detailed information necessary to answer your specific questions about acceptance criteria and a study proving device performance.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Details on experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Description of a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is primarily for regulatory clearance and focuses on the substantial equivalence determination. To find the information you're looking for, you would typically need to refer to the 510(k) premarket notification submission itself or potentially peer-reviewed publications related to the device, which are not provided here.
§ 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.