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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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The NeuroVision JJB System is intended to provide stimulation of spinal nerves during surgery of the spine, and intraoperative electrical stimulus pulses to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves, in the following: a) Location and evaluation of spinal nerves, using the System's Screw Test, Detection, and/or Free Run EMG Functions; and b) Location and identification of spinal nerves, using the System's Nerve Retraction Function.

The NeuroVision JJB System is designed for use in conjunction with other NuVasive devices to assist in gaining controlled access to, and visualization of, the spinal nerve root, foramina, and surrounding tissues of the spine via uniportal or biportal approach, where anatomical restrictions safely permit.

The NVJJB System utilizes conventional neurophysiologic monitoring to reduce the risk of nerve injury during instrumented spine surgery. In the procedure, stimulus evoked electromyography is used to determine changes in nerves. Corresponding Stimulus Evoked Electromyography is used as 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 reusable conductive probes, electrodes, and electrode leads.

The provided text is a 510(k) summary for the NuVasive NeuroVision JJB System, and it outlines the device's description, intended use, and comparison to predicate devices. It also includes an FDA clearance letter. However, this document does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies against specific acceptance criteria. The clearance letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices... FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with all other requirements of the Act..."

Therefore, I cannot extract the requested information from the provided text.

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