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.

Device Description

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)
1. Motor Evoked Potential (MEP)
1. Somatosensory Evoked Potential (SSEP)
1. Remote Reader
1. Guidance
1. 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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 14, 2014

NuVasive, Inc. Mr. Jeremy Markovich Associate Manager, Regulatory Affairs 7475 Lusk Blvd. San Diego, CA 92121

Re: K141968

Trade/Device Name: NuVasive NVM5 System Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical nerve locator Regulatory Class: Class II Product Code: PDQ, ETN, GWF, HAW, IKN, OLO Dated: October 14, 2014 Received: October 15, 2014

Dear Mr. Markovich.

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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Felipe Aquel -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141968

Device Name NuVasive® NVM5® System

Indications for Use (Describe)

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.

· 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 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 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, also in gray.

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

A. Submitted by:

Jeremy Markovich Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800 Date Prepared: October 14, 2014

B. Device Name

Trade or Proprietary Name:	NuVasive® NVM5® System
Common or Usual Name:	Neurological surgical monitor;Stereotaxic Instrument
Classification Name:	Surgical Nerve Stimulator/Locator;Evoked response electrical stimulator;Neurological stereotaxic instrument;Electromyography (EMG) monitor/stimulator
Device Class:	Class II
Classification:	§874.1820, §882.1870, §882.4560, §890.1375
Product Code:	PDQ, ETN, GWF, HAW, IKN, OLO

C. Predicate Devices

The subject NuVasive NVM5 System is substantially equivalent to the predicate NuVasive NVM5 System - 510(k) - K132694.

D. Device Description

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Image /page/5/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, also in gray.

1. Electromyography (EMG)
1. Motor Evoked Potential (MEP)
1. Somatosensory Evoked Potential (SSEP)
1. Remote Reader
1. Guidance
1. Bendini

E. Intended Use

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

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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.

F. Technological Characteristics

As was established in this submission, the subject NVM5 System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, intended use, material composition, and functions. The technological differences within this 510(k) that were shown to be substantially equivalent to the predicates include:

Modified MEP stimulation parameters
Modified SSEP algorithm
. Additional Bendini features

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Image /page/7/Picture/6 description: The image shows the logo for Nuvasive. The logo is vertically oriented, with the word "NUVASIVE" in a light gray, sans-serif font. Below the name is the phrase "Speed of Innovation" in a smaller, italicized font. Below the text is a stylized graphic that appears to be a purple and gray eye.

Specification/Property	Predicate DeviceNuVasive NVM5 System (K132694)	Subject DeviceNuVasive NVM5 System
Intended Use /Indications forUse	The NVM5® System is a medical device that is intended for intraoperativeneurophysiologic monitoring during spinal surgery. The device provides informationdirectly to the surgeon, to help assess a patient's neurophysiologic status. NVM5provides this information by electrically stimulating nerves via electrodes located onsurgical accessories and monitoring electromyography (EMG), transcranial or lumbarmotor evoked potential (MEP), or somatosensory evoked potential (SSEP) responses ofnerves. The System also integrates Bendini® software used to locate spinal implantinstrumentation for the placement of spinal rods.XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locateand evaluate spinal nerves, and is used as a nerve avoidance tool. Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon tolocate 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 EMGactivity of spinal nerves by continually displaying a live stream waveform of anymechanically induced myotome contractions. Twitch Test (Train of Four) The Twitch Test Function allows the surgeon toassess moderate degrees of neuromuscular block in effect by evaluating musclecontraction following a train of four stimulation pulses. MEP Transcranial or lumbar (i.e., conus in region of L1-L2) stimulationtechniques for motor evoked potentials are used to assess for acute dysfunction inaxonal conduction of the corticospinal tract and peripheral nerves. The MEPfunction provides an adjunctive method to allow the surgeon to monitor spinalcord and motor pathway integrity during procedures with a risk of surgicallyinduced motor injury. SSEP The SSEP function allows the surgeon to assess sensory spinal cordfunction in surgical procedures during which the spinal cord is at risk. Remote Reader - The Remote reader function provides real time remote access tothe 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 orpercutaneous pedicle cannulation procedures in the lumbar and sacral spine(L1-S1) of adult patients, and when used in conjunction with radiographicimaging and EMG, allows the surgeon to assess the angulation of systemaccessories relative to patient spinal anatomy for the creation of a cannulationtrajectory for bone screw placement. Bendini - The Bendini Spinal Rod Bending function is used to locate spinalimplant system instrumentation (screws, hooks) to determine their relativelocation to one another to generate bend instructions to shape a spinal rod. Asurgeon 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 intraoperativeneurophysiologic monitoring during spinal surgery. The device provides informationdirectly to the surgeon, to help assess a patient's neurophysiologic status. NVM5provides this information by electrically stimulating nerves via electrodes located onsurgical accessories and monitoring electromyography (EMG), transcranial or lumbarmotor evoked potential (MEP), or somatosensory evoked potential (SSEP) responses ofnerves. The System also integrates Bendini® software used to locate spinal implantinstrumentation for the placement of spinal rods.XLIF (Detection) The XLIF (Detection) function allows the surgeon tolocate and evaluate spinal nerves, and is used as a nerve avoidance tool. Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon tolocate 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 EMGactivity of spinal nerves by continually displaying a live stream waveform ofany mechanically induced myotome contractions. Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon toassess moderate degrees of neuromuscular block in effect by evaluatingmuscle contraction following a train of four stimulation pulses. MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulationtechniques for motor evoked potentials are used to assess for acute dysfunctionin axonal conduction of the corticospinal tract and peripheral nerves. TheMEP function provides an adjunctive method to allow the surgeon to monitorspinal cord and motor pathway integrity during procedures with a risk ofsurgically induced motor injury. SSEP The SSEP function allows the surgeon to assess sensory spinal cordfunction in surgical procedures during which the spinal cord is at risk. Remote Reader The Remote reader function provides real time remoteaccess to the NVM5 System for a monitoring physician outside of theoperating room Guidance - The Guidance function is intended as an aid for use in either openor percutaneous pedicle cannulation procedures in the lumbar and sacralspine (L1-S1) of adult patients, and when used in conjunction withradiographic imaging and EMG, allows the surgeon to assess the angulationof system accessories relative to patient spinal anatomy for the creation of acannulation trajectory for bone screw placement. Bendini - The Bendini Spinal Rod Bending function is used to locate spinalimplant system instrumentation (screws, hooks) to determine their relativelocation to one another to generate bend instructions to shape a spinal rod. Asurgeon is able to use those instructions and bend a rod using the BendiniBender, a mechanical rod bender.
Specification/Property	Predicate DeviceNuVasive NVM5 System (K132694)	Subject DeviceNuVasive NVM5 System
SoftwareModalities /Functionalities	XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test TceMEP SSEP Remote Monitoring Guidance Bendini	XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test MEP SSEP Remote Monitoring Guidance Bendini
Algorithms	XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test TceMEP SSEP Guidance Bendini	XLIF Detection – Identical algorithm as predicate Basic & Dynamic Screw Test – Identical algorithm as predicate Free Run EMG – Identical algorithm as predicate Twitch Test (Train of Four) - Identical algorithm as predicate MEP - Modified stimulation parameters SSEP - Addition of baseline algorithm and optional view Guidance - Identical algorithm as predicate Bendini - Identical rod-bending algorithm as predicate
Total AvailableChannels	32	32
Headbox/Patient Module	Yes	Yes
IEC 60601-1Compliant	Yes	Yes
Full Scale ViewRange	$\pm 0.5\mu V \text{ to } \pm 8mV$	$\pm 0.5\mu V \text{ to } \pm 8mV$
FrequencyResponse	3 Hz to 4.8 kHz	3 Hz to 4.8 kHz
User Interface	NuVasive-supplied computer orNuVasive provided touch screen and [optional] keyboard/mouse	NuVasive-supplied computer orNuVasive provided touch screen and [optional] keyboard/mouse
RemoteMonitoring	Yes	Yes
Train of FourTesting	Yes	Yes
Needle Electrodes	Various	Various
Specification/Property	Predicate DeviceNuVasive NVM5 System (K132694)	Subject DeviceNuVasive NVM5 System
SurfaceElectrodes	Various	Various
Electrode LeadsStimulatingProbes	Various	Various
RecordingChannels	EMG, MEP, and SSEP	EMG, MEP, and SSEP
EMG Modalities	XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test	XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Automatic Stimulation	Automatic Stimulation
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Yes	Yes (Identical to predicate)
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Yes	Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Automatic Stimulation	Automatic Stimulation
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Yes	Yes (Identical to predicate)
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Yes	Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Manual Stimulation	Manual Stimulation
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Yes	Yes (Identical to predicate)
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Yes	Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Manual and Automatic Stimulation	Manual and Automatic Stimulation
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Yes	Yes (Identical to predicate)
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Yes	Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Manual and Automatic Stimulation	Manual and Automatic Stimulation
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Yes	Yes (Identical to predicate)
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Yes	Yes
Specification/Property	Predicate DeviceNuVasive NVM5 System (K132694)	Subject DeviceNuVasive NVM5 System
	SSEP
Types of Modes	Manual Stimulation	Manual Stimulation
Threshold Valuesfor Color AlertsAudio feedback	Yes	Yes (Identical to predicate)
	Yes	Yes
Screen-sharingaccessibility	Remote Monitoring	Remote Monitoring
	Guidance
Clinical Use	Requires input derived from CT, MRI, or radiographic imagesIntended to assist the surgeon in cannulating the pedicle based on user predefined trajectoryIntegrated with EMG stimulation	Requires input derived from CT, MRI, or radiographic imagesIntended to assist the surgeon in cannulating the pedicle based on user predefined trajectoryIntegrated with EMG stimulation
PerformanceRequirements	Angular tolerance of ±2°Confirmation of alignment to pre-planned trajectorySeamlessly integrated with an insulated Jamshidi Needle	Angular tolerance of ±2°Confirmation of alignment to pre-planned trajectorySeamlessly integrated with an insulated Jamshidi Needle
IEC 60601Compliant	YES	YES
User Interface	Touch screen, graphical user interface and audio	Touch screen, graphical user interface and audio
Components	BendiniOptical (IR) tracking technology system, IR tracking instruments, computer.	Optical (IR) tracking technology system, IR tracking instruments, computer.
User Interface	Touch screen, graphical user interface and audio.	Touch screen, graphical user interface and audio.
IEC 60601Compliant	YES	YES
Instrumentation	IR Digitizer (with integrated passive spheres)Rod Bender	IR Digitizer (with integrated passive spheres)Rod Bender

Comparison of Technical Characteristic Table 1 –

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ONUVASIVE:

510(k) Premarket Notification
NuVasive® NVM5® System

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ONUVASIVE:

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Image /page/11/Picture/1 description: The image shows the logo for NuVasive. The logo consists of a purple and gray abstract leaf-like shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, with the word "Speed" in purple and the rest of the phrase in gray.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NVM5 System is substantially equivalent to other predicate devices and to verify that the NVM5 System meets design specifications and performance characteristics, based upon the intended use. The NVM5 System was subjected to Verification and Validation Testing according to the Software Requirements Specifications defined for the system, to include the modifications made as part of the subject device. Laboratory bench top and cadaveric testing was performed as follows:

To verify parameters such as pulse width and amplitude, current polarity, ● stimulation rates and response detection ranges.
To validate the effectiveness of boundary conditions, extreme values, and nominal entries displayed on the GUI.
To verify point acquisition, user defined inputs, and rod bending instructions. ●
To validate the user defined inputs, point acquisition, and measurements result in proper bend instructions and/or calculated offsets.

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.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NVM5 System has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 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.