(109 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 Neuro Vision 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 neurophysiogic 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 describes a 510(k) summary for the NuVasive NeuroVision JJB System, an electromyography (EMG) monitor/stimulator. However, the document does not contain information regarding specific acceptance criteria, a study proving the device meets those criteria, or details of a validation study (sample size, ground truth, expert qualifications, etc.).
The document focuses on:
- Device Description: What the device is and how it works (neurophysiologic monitoring, stimulus evoked electromyography).
- Intended Use: Its purpose in spinal surgery (nerve location, evaluation, and identification).
- Comparison to Predicate Device: States that the subject device is substantially equivalent to a previously marketed NuVasive NeuroVision JJB System and has identical indications for use and principles of operation, raising no new safety or effectiveness issues.
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence to the predicate device.
Therefore, I cannot provide the requested information in the table or the subsequent points because the provided text does not contain any details about acceptance criteria, a study proving performance against those criteria, or validation study specifics.
The FDA’s clearance is based on the device being substantially equivalent to a predicate, meaning extensive new clinical performance studies demonstrating acceptance criteria were likely not required for this particular 510(k) submission.
To reiterate, the following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.