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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 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 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, an Electromyography (EMG) monitor/stimulator. It details device information, intended use, and substantial equivalence to predicate devices, but does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on regulatory clearance by demonstrating substantial equivalence to already cleared devices, rather than presenting a performance study with detailed acceptance criteria and results.

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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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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.

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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:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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