(43 days)
The Ball-Tip Monopolar Stimulating Probe is intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
The probe includes a metal ball tip, an insulated, flexible metal shaft, and a protected pin electrical connector to attach the probe to a stimulator.
The provided text describes a 510(k) summary for the "Xomed Ball-Tip Monopolar Stimulator Probe." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a new, innovative device that would then be validated by a study.
Therefore, the requested information about acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this document.
The 510(k) summary explicitly states:
- "The Xomed Ball-Tip Monopolar Stimulator Probe is substantially equivalent to the Magstim/Neurosign Pedicle Hole Probe as described in K980148 in its intended use, materials, and overall design."
This type of submission relies on the established safety and effectiveness of the predicate device (K980148) by demonstrating that the new device shares the same intended use, technological characteristics, and performance characteristics, or raises no new questions of safety and effectiveness. It does not involve a study to "prove the device meets acceptance criteria" in the way a novel device with new performance claims might.
In summary, the provided document is a declaration of substantial equivalence, not a report of a performance study with acceptance criteria.
§ 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.