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The Next Generation NVM5® System is a medical device that is intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surger and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMC), transcranial or lumbar motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates BendiniTM software used to locate spinal implant instrumentation for the placement of spinal rods. · XLIF (Detection) — The XLIF (Detection) function allows the surgeon to locate and evaltiate spinal nerves, and is used as a nerve avoidance tool.

· Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying alive stream waveform of any mechanically induced myotome contractions.

· Twitch Test (Train of Four) — The Twitch Test function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.

· MEP - Transcranial or lumbar (i.e., conus in region ofLI-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The ME? function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.

· SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.

• Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the NG-NVM5 System for additional physicians.

· Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

The NG-NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NG-NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover. a Twitch Test function is utilized to test the ability of the nerve to respond, or contract. following four stimulation pulses to determine the presence of neuromuscular block.

The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods as well as providing guidance to support the delivery of pedicle screws during EMG monitoring. Lastly, the system offers real-time control capabilities (local wireless control) to the NG-NVM5 System by additional monitoring physicians, in addition to remote monitoring capabilities.

In summary, the NG-NVM5 System includes the following five (5) software functionalities / modalities:

• 1. Electromyography (EMG)
• Motor Evoked Potential (MEP) 2.
• 3. Somatosensory Evoked Potential (SSEP)
• 4. Remote Access
• 5. Bendini

The NG-NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.

This document describes the NuVasive Next Generation NVM5 System, a medical device for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities.

The relevant information regarding acceptance criteria and study to prove device meets the acceptance criteria is detailed below:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria alongside reported device performance in distinct quantitative values. Instead, it states that "The results of these studies showed that the subject NG-NVM5® System meets the same acceptance criteria as the performance of the predicate device". The comparison table provided (Table 1 – Comparison of Technical Characteristics on page 6) focuses on technological characteristics and functionalities of the subject device against predicate devices, indicating equivalence rather than specific performance metrics against pre-defined thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Laboratory bench top testing" and "Verification and Validation Testing" but does not specify sample sizes for these tests, nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective nature of data). This suggests that the studies were non-clinical in nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies described are non-clinical benchtop and verification/validation tests, not studies requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document, as the studies are non-clinical benchtop and verification/validation tests, not clinical studies requiring adjudication methods for ground truth establishment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness studies. The device is for intraoperative neurophysiologic monitoring and spinal rod bending assistance, and the studies described are non-clinical verification and validation activities. There is no indication of AI assistance being evaluated in comparison with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The studies described are non-clinical benchtop and verification/validation tests focusing on the device's technical performance, including the accuracy of angle and offset measurement and the functionality of the GUI and system components. This implicitly evaluates some aspects of the device's standalone performance (e.g., the Bendini software's ability to locate instrumentation and generate bend instructions). However, the device is intended for intraoperative use, with direct information provided to the surgeon, indicating a human-in-the-loop context. The document does not explicitly delineate studies demonstrating "algorithm only without human-in-the-loop performance" as a separate category of evaluation beyond the aforementioned technical tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical benchtop tests, the "ground truth" would have been established by engineering specifications, calibrated measurement tools, and predefined functional requirements (e.g., ensuring a certain angle is measured correctly by the device against a known standard). This is implicit in "Laboratory bench top testing was performed to verify accuracy of angle and offset measurement and validate that the graphical user interface (GUI) and system components function as intended."

8. The sample size for the training set

The document describes non-clinical testing for verification and validation and does not mention training sets, as it is not an AI/machine learning device in the context of data-driven model training.

9. How the ground truth for the training set was established

As no training set is mentioned for an AI/machine learning model, this information is not applicable. The device's validation is based on engineering specifications and direct performance measurements.

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