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The NeuroVision IJB System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location of nerves during percutaneous surgery of the spine, 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. The NeuroVision JJB System is designed for use in conjunction with the NuVasive guided spinal arthroscopy system to assist in gaining controlled percutaneous access to the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit.

The NeuroVision JJB System (NV JJB) is an electronic device which uses arthroscopic surgical instruments, electrodes, and probes to stimulate nerves with electrical energy, and through the use of electromyography (EMG) electrodes, monitors the sensitivity, and assists in determining the location of nerves during percutaneous surgery of the spine.

The device employs a "Detection" routine which directs brief electrical stimulus pulses through the distal tip of the NuVasive Dilating Cannula as it penetrates tissue to the operative target. Through a series of EMG electrodes placed on the muscle groups associated with the nerves at the operative level of the spine, the NeuroVision JJB System monitors EMG activity in these muscle groups and, when the Cannula tip draws sufficiently near to one such nerve that the electrical energy it emits is strong enough to depolarize the nerve and evoke an EMG response, alerts the surgeon that the Cannula tip is in proximity to that nerve.

By the same method, a "Direction" routine may be used to sequentially activate four orthogonal stimulation electrodes surrounding the Cannula tip, and thereby determine the orthogolial similation closest nerve lies. This direction is displayed on a graphical touch screen.

An additional feature of the NeuroVision JJB System is a hand-held electrical probe which is used to abonain whomer a the screw hole prior to screw insertion or placed on The ban tip of the prooe is placed in as been breached by the screw or tap, the the mstalled screw nead. If the pearlers was the adjacent nerve roots and they will depolarize at a lower stimulation current. The screw test algorithm determines the depolarization (threshold) current for all 8 EMG channels. The surgeon may also set a baseline threshold) current by stimulating a nerve root directly with the probe. The surgeon may choose to display the screw test threshold current relative to this baseline.

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, comprised of an emboduced compater ressable conductive probe cables, electrodes, and electrode leads.

The provided text describes a 510(k) summary for the NeuroVision JJB System, which is an electromyography (EMG) monitor/stimulator. However, it does not contain any information regarding specific acceptance criteria, performance data from a study, sample sizes, ground truth establishment, or comparative effectiveness studies.

The document primarily focuses on:

• Device Description: How the NeuroVision JJB System works, its components, and its "Detection" and "Direction" routines, including a special hand-held probe for testing pedicle screw breaches.
• Intended Use: Intraoperative EMG surveillance to assist in nerve localization during percutaneous spine surgery.
• Technological Characteristics Comparison: Stating that the device has identical indications for use, equivalent materials, design features, and functional characteristics to a predicate device (K002677: NuVasive INS-1 Intraoperative Nerve Surveillance System). It highlights minor interface changes (touch screen vs. LED/push button) and the addition of a hard drive for recording.
• Safety and Effectiveness: A claim that "Due to the equivalency of indications for use, materials of composition, design features, method of use, and functional characteristics, the device raises no new safety or effectiveness issues."
• FDA Clearance Letter: A formal letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested table and study details because this information is not present in the provided context. The 510(k) summary relies on demonstrating substantial equivalence to a predicate device rather than presenting new performance study data against pre-defined acceptance criteria.

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