(80 days)
The NeuroVision JJB System is used for intraoperative monitoring and neurological status assessment by the administration of brief electrical stimulus pulses to neural tissues and the EMG monitoring of the associated muscle groups. The System is used in conjunction with other NuVasive devices to assist in gaining controlled access to, and visualization of, the spine.
The NVJJB System utilizes conventional neurophysiologic monitoring to reduce the incidence of injury to nerve roots during instrumented spine surgery. In the procedure, stimulus evoked electromyography is used to determine changes in nerves. Corresponding muscle groups are monitored using surface electrodes, while stimulation is used to detect nerve responses.
The NeuroVision JJB System consists of a reusable Patient Module, a Control Unit comprised of an embedded computer with touch screen controls and an interface card, and an assortment of disposable and reusable conductive probes, electrodes, and electrode leads.
The provided text is a 510(k) summary for the NuVasive NeuroVision JJB System, an Electromyography (EMG) monitor/stimulator. It details device information, intended use, and substantial equivalence to predicate devices, but does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on regulatory clearance by demonstrating substantial equivalence to already cleared devices, rather than presenting a performance study with detailed acceptance criteria and results.
§ 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.