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The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. 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 (EMG), transcranial or lumbar motor evoked potential (MEP), or somatosensoty evoked potential (SSEP) responses of nerves. The System also integrates Bendini® 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 evaluate 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 a live 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 MEP 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 Reader - The Remote Reader function provides real time remote access to the NVM5 System for a monitoring physician outside of the operating room.

· Guidance - The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar and sacral spine (LI-SI) of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the angulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.

· 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 NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. 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 (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.

Additionally, the NVM5 System includes an integrated stereotactic guidance system (NVM5 Guidance) to support the delivery of pedicle screws during EMG monitoring. The System also integrates Bendini software used to locate spinal implant instrumentation for the placement of spinal rods. Lastly, the system also offers an optional screen sharing application to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVM5 System includes the following six (6) software functionalities / modalities:

1. Electromyography (EMG)
2. Motor Evoked Potential (MEP)
3. Somatosensory Evoked Potential (SSEP)
4. Remote Reader
5. Guidance
6. Bendini

The 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.

The provided text describes the NuVasive NVM5 System, a medical device for intraoperative neurophysiologic monitoring during spinal surgery. The document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device (NuVasive NVM5 System K143641).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The provided text does not present a formal table of acceptance criteria with corresponding device performance metrics in a quantitative way for all functionalities. It lists "Performance Requirements" for its "Guidance" function.

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 states:

• "Nonclinical testing was performed..."
• "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."

The text does not specify the sample size used for the test set or the data provenance (country of origin, retrospective or prospective). The testing described appears to be laboratory-based rather than involving patient data.

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)

The document does not mention the use of experts to establish ground truth for the test set. The testing described is nonclinical and laboratory-based.

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

The document does not describe any adjudication method. Given the nonclinical nature of the testing mentioned (laboratory bench top testing), it's unlikely an adjudication method for human interpretation would be relevant.

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

No MRMC comparative effectiveness study is mentioned. The device is a "Surgical Nerve Stimulator/Locator" and "Neurological surgical monitor," which directly provides information to the surgeon. While it aids the surgeon, it's not described as an AI system that improves "human readers" in an MRMC study context. The "Remote Reader" function only provides remote access for a monitoring physician, not an AI assistance for image interpretation.

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

The document describes the device's performance in a standalone context (without a human interpreting the outputs of an AI algorithm, but with a human using the direct outputs of the device). The "nonclinical testing" and "laboratory bench top testing" were performed to verify and validate the system's performance against design specifications. The device provides "information directly to the surgeon," indicating its primary mode of operation is standalone in generating the direct neurophysiologic monitoring data.

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

For the "Guidance" function, the ground truth for angular and offset accuracy would likely be physical measurements against known standards or calibrated equipment during the benchtop testing. For the neurophysiologic monitoring functions (EMG, MEP, SSEP), the ground truth for verification and validation would likely involve electrical signal generation and measurement against known physiological parameters or simulated physiological responses. The text does not explicitly state the specific type of ground truth but implies it's based on technical specifications and device functionality.

8. The sample size for the training set

The document does not mention a training set or machine learning components that would necessitate a training set. The device's algorithms are described as largely "identical" to a predicate device or having "modified stimulation parameters" for MEP and "addition of baseline algorithm and optional view" for SSEP, suggesting rule-based or signal processing algorithms rather than trainable machine learning models.

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

Not applicable, as a training set is not mentioned.

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