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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 Neuro Vision 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. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical studies with specified acceptance criteria and performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details, as these are typically part of a full clinical validation study which is not explicitly detailed in a 510(k) summary focused on substantial equivalence.

The document explicitly states:

• "The subject NeuroVision JJB System is substantially equivalent to the NeuroVision JJB System currently manufactured and distributed commercially in the U.S. by NuVasive." (Section C. Predicate Devices)
• "The subject device has indications for use identical to those of its predicate, and employs the same principles of operation. Due to this equivalency, the device raises no new safety or effectiveness issues." (Section F. Comparison to Predicate Devices)

This indicates that the focus of this submission is on demonstrating similarity to an already approved device rather than presenting new performance data against specific acceptance criteria.

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