(30 days)
The NeuroVision JJB System is intended to provide stimulation of spinal nerves during surgery of the spine, and intraoperative electromyographic (EMG) nerve surveillance to assist, by administration of brief 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, intervertebral disc, 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 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, focusing on its substantial equivalence to a predicate device for regulatory approval. It does not contain any information regarding clinical studies, acceptance criteria, or performance data for the device. Therefore, I cannot complete the table or answer the specific questions about studies, sample sizes, ground truth, or expert qualifications based on the provided text.
The document primarily describes:
- Device Name: NuVasive NeuroVision JJB System
- Common Name: Electromyography (EMG) monitor/stimulator
- Intended Use: To provide stimulation of spinal nerves during spine surgery and intraoperative electromyographic (EMG) nerve surveillance to assist in location and evaluation of spinal nerves and identification of spinal nerves.
- Device Description: Consists of a reusable Patient Module, Control Unit, and probes/electrodes.
- Predicate Device: A previously marketed NuVasive NeuroVision JJB System.
- Conclusion: The device is substantially equivalent to its predicate, raising no new safety or effectiveness issues.
No information regarding acceptance criteria or a study proving the device meets those criteria is present in the provided text.
§ 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.