(116 days)
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 somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.
- o 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 of L1-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 (L1-S1) 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:
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- Electromyography (EMG)
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- Motor Evoked Potential (MEP)
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- Somatosensory Evoked Potential (SSEP)
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- Remote Reader
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- Guidance
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- 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 a 510(k) premarket notification for the NuVasive NVM5 System. It asserts substantial equivalence to a predicate device (NuVasive NVM5 System - 510(k) - K132694) based on indications for use, technological characteristics, and performance testing.
Here's an breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from "Performance Requirements" for Guidance function) | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Angular tolerance of ±2° | Nonclinical testing (laboratory benchtop and cadaveric) was performed. "The results of these studies showed that the subject NVM5® System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent." |
| Confirmation of alignment to pre-planned trajectory | Nonclinical testing (laboratory benchtop and cadaveric) was performed. "The results of these studies showed that the subject NVM5® System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent." |
| Seamlessly integrated with an insulated Jamshidi Needle | Nonclinical testing (laboratory benchtop and cadaveric) was performed. "The results of these studies showed that the subject NVM5® System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent." |
| Other parameters (General) | Verification of parameters such as pulse width and amplitude, current polarity, stimulation rates, and response detection ranges. |
| Boundary conditions, extreme values, and nominal entries on GUI (General) | Validation of the effectiveness of boundary conditions, extreme values, and nominal entries displayed on the GUI. |
| Point acquisition, user defined inputs, and rod bending instructions (Bendini) | Verification of point acquisition, user-defined inputs, and rod bending instructions. |
| User-defined inputs, point acquisition, and measurements for bend instructions/offsets (Bendini) | Validation that user-defined inputs, point acquisition, and measurements result in proper bend instructions and/or calculated offsets. |
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 "nonclinical testing" including "laboratory bench top and cadaveric testing". It does not specify the sample size for these tests, nor the country of origin of the data, or if it was retrospective or prospective.
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 provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be hardware/software verification and validation, not clinical performance evaluation with expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe an adjudication method, as the testing appears to be based on technical specifications and functional validations rather than subjective clinical assessment requiring adjudication.
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 in the provided text. The device is a surgical monitoring system, not explicitly an AI-assisted diagnostic device, and the testing described is nonclinical.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Performance Data" section discusses "Verification and Validation Testing according to the Software Requirements Specifications" and "Laboratory bench top and cadaveric testing". This implies testing of the algorithm (software functionalities) and hardware system, which would largely be standalone performance testing to verify it meets design specifications. However, "human-in-the-loop" is a core aspect of the device's intended use (providing information directly to the surgeon), so the distinction might not be as clear-cut as with an independent AI diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the nonclinical testing appears to be based on established engineering and physiological parameters (e.g., "pulse width and amplitude, current polarity, stimulation rates and response detection ranges," "boundary conditions, extreme values, and nominal entries displayed on the GUI," "proper bend instructions and/or calculated offsets"). No mention of clinical outcomes data, pathology, or expert consensus in relation to diagnostic ground truth is made for the described premarket notification testing.
8. The sample size for the training set
The document describes nonclinical verification and validation testing, not a machine learning model that would require a "training set." Therefore, no training set sample size is provided.
9. How the ground truth for the training set was established
As described above, the document does not mention a training set, so no information regarding its ground truth establishment is provided.
§ 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.