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.

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:

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

Feature	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)
Angular tolerance	±2° (for Guidance function)	Angular tolerance of ±2° (for Guidance function) - Implied to be met as it states "identical to predicate" for the algorithm and "meets or exceeds the performance"
Alignment	Confirmation of alignment to pre-planned trajectory (for Guidance function)	Confirmation of alignment to pre-planned trajectory (for Guidance function) - Implied to be met
Integration	Seamlessly integrated with an insulated Jamshidi Needle (for Guidance function)	Seamlessly integrated with an insulated Jamshidi Needle (for Guidance function) - Implied to be met
All other listed features (EMG, MEP, SSEP, etc.)	Functionalities and algorithms of the predicate device (K143641)	Functionalities and algorithms are identical or modified with "identical stimulation parameters" or "addition of baseline algorithm and optional view" and the overall system is stated to "meet or exceed the performance of the predicate device". Specific quantitative performance data is not provided in a table form in this excerpt.

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.

Summary

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

January 13, 2016

Nuvasive Incorporated Olga Lewis Lead Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K152942

Trade/Device Name: Nuvasive NVM5 System Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ, ETN, GWF, HAW, OLO, IKN Dated: October 2, 2015 Received: October 5, 2015

Dear Ms. Lewis:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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" (21 CFR 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,

William J. Heetderks -S

for

Carlos L. Peña, PhD, MS 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) K152942

Device Name NuVasive® NVM5 System

Indications for Use (Describe)

· XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.

· 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.

· 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.

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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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:

Olga Lewis Lead Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800 Date Prepared: October 2, 2015

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 K143641.

D. Device Description

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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.

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.

Technological Characteristics F.

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 additional angular and offset spinal parameter assessment.

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NUVASIVE.

Specification/Property	Predicate DeviceNuVasive NVM5 System (K143641)	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 roomGuidance - 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 roomGuidance - The Guidance function is intended as an aid for use in either openor percutaneous 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 an intraoperativeassessment tool used to locate spinal implant system instrumentation (screws,hooks) to determine their relative location to one another to generate bendinstructions to shape a spinal rod. A surgeon is able to use those instructionsand bend a rod using the Bendini Bender.
Specification/Property	Predicate DeviceNuVasive NVM5 System (K143641)	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 aspredicate Free Run EMG – Identical algorithm as predicate Twitch Test (Train of Four) – Identical algorithm aspredicate 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 ModuleIEC 60601-1Compliant	Yes	Yes
Full Scale ViewRange	$± 0.5µV to ± 8mV$	$± 0.5µV to ± 8mV$
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 (K143641)	Subject DeviceNuVasive NVM5 System
SurfaceElectrodes	Various	Various
Electrode Leads	Various	Various
StimulatingProbes	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 StimulationYesYes	Automatic StimulationYes (Identical to predicate)Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Basic & Dynamic Screw TestYesYes	Basic & Dynamic Screw TestYes (Identical to predicate)Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Free Run EMGYesYes	Free Run EMGYes (Identical to predicate)Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	Twitch TestYesYes	Twitch TestYes (Identical to predicate)Yes
Types of ModesThreshold Valuesfor Color AlertsAudio feedback	MEPYesYes	MEPYes (Identical to predicate)Yes
Specification/Property	Predicate DeviceNuVasive NVM5 System (K143641)	Subject DeviceNuVasive NVM5 System
Types of Modes	Manual Stimulation	Manual Stimulation
Threshold Valuesfor Color AlertsAudio feedback	Yes	Yes (Identical to predicate)
Screen-sharingaccessibility	Remote Monitoring	Remote Monitoring
Clinical Use	Requires input derived from CT, MRI, or radiographic images Intended to assist the surgeon in cannulating the pedicle based on user predefined trajectory Integrated with EMG stimulation	Requires input derived from CT, MRI, or radiographic images Intended to assist the surgeon in cannulating the pedicle based on user predefined trajectory Integrated with EMG stimulation
PerformanceRequirements	Angular tolerance of ±2° Confirmation of alignment to pre-planned trajectory Seamlessly integrated with an insulated Jamshidi Needle	Angular tolerance of ±2° Confirmation of alignment to pre-planned trajectory Seamlessly 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	Optical (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 Mobile application	IR Digitizer (with integrated passive spheres) Rod Bender Mobile application

Comparison of Technical Characteristics Table 1 -

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NUVASIVE:

510(k) Premarket Notification
NuVasive® NVM5® System

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NUVASIVE: =============================================================================================================================================================================

510(k) Premarket Notification
NuVasive® NVM5® System

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Image /page/11/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray 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 a gray line extending from the left side of the phrase.

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 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 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 device.

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.