The NVM5® System is a medical device that is 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 LI-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-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:

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 document is a 510(k) Premarket Notification for the NuVasive® NVM5® System, a medical device for intraoperative neurophysiologic monitoring during spinal surgery. The document focuses on demonstrating substantial equivalence to a predicate device (NuVasive NVM5 System - K141968) rather than presenting a detailed study proving the device meets explicit acceptance criteria in the format typically used for clinical performance studies of AI/ML devices.

However, based on the nonclinical testing section (Section G: Performance Data), we can infer the type of acceptance criteria and the nature of the study conducted to demonstrate the device's performance.

Here's an attempt to structure the information based on your request, with inferred details where explicit information is missing from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the subject device performs similarly to its predicate and meets design specifications. The key performance aspects mentioned are related to the functional capabilities of the device.

Acceptance Criteria (Inferred from testing scope)	Reported Device Performance (Summary from Section G)
Verification of stimulation parameters (pulse width, amplitude, current polarity, rates)	Met or exceeded the performance of the predicate device.
Verification of response detection ranges	Met or exceeded the performance of the predicate device.
Validation of effectiveness of boundary conditions, extreme values, and nominal entries on GUI	Met or exceeded the performance of the predicate device.
Verification of point acquisition for Guidance function	Met or exceeded the performance of the predicate device.
Verification of user-defined inputs for Guidance function	Met or exceeded the performance of the predicate device.
Verification of rod bending instructions for Bendini function	Met or exceeded the performance of the predicate device.
Validation that user-defined inputs, point acquisition, and measurements result in proper bend instructions and/or calculated offsets for Bendini function	Met or exceeded the performance of the predicate device.
Angular tolerance for Guidance function (explicitly mentioned as performance requirement for Guidance)	The subject device, like the predicate, is designed to meet an angular tolerance of ±2° and confirm alignment to pre-planned trajectory. The studies "met or exceeded" this performance.

2. Sample Size for the Test Set and Data Provenance

The document describes nonclinical testing, which includes:

Laboratory bench top testing: This suggests no human patient data was used.
Cadaveric testing: This implies the use of cadaver specimens.

Therefore:

Sample Size for Test Set: Not specified in terms of number of cadavers or bench tests. No human patient test set was explicitly described for performance validation.
Data Provenance: Laboratory bench top and cadaveric testing. No country of origin is specified, but typically this would be conducted within the manufacturer's R&D facilities or contracted labs. The data is retrospective in the sense that it's performed on non-living subjects or simulated conditions rather than live clinical cases for this specific submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Given that the testing was nonclinical (bench-top and cadaveric), the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (like radiologists for imaging) does not directly apply here. Instead, ground truth would be established by engineering specifications, known physical properties, and controlled experimental conditions.

Experts: Not applicable in the context of clinical ground truth. The "effectiveness of boundary conditions, extreme values, and nominal entries" and "proper bend instructions and/or calculated offsets" would be evaluated against established engineering principles and the predicate device's known performance.
Qualifications: Not specified. It would likely involve engineers, technicians, and potentially surgeons for cadaveric testing evaluating the functional aspects of the device.

4. Adjudication Method for the Test Set

Not applicable for this type of nonclinical verification and validation testing. Adjudication methods like 2+1 or 3+1 are used for human expert consensus on clinical data. Performance here would be measured against engineering tolerances and functional outputs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was described. This document focuses on demonstrating substantial equivalence of the device's functional performance to its predicate through nonclinical testing, not on comparing human reader performance with and without AI assistance. The device itself is a neurophysiological monitoring system, which aids a surgeon, but the submission doesn't detail a study comparing surgeon performance.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance)

The document describes a standalone device performing its intended functions (monitoring EMG, MEP, SSEP, providing guidance, and bend instructions). The tests are likely evaluating the system's output accuracy and reliability against a known truth or a predicate's output. While a human (surgeon or technician) interacts with and interprets the information from the device, the validation described is of the device's output itself, independent of the human 'decision-making' aspect. So, in essence, the nonclinical testing demonstrates the "algorithm only" performance (i.e., the system's ability to fulfill its specified functions).

7. Type of Ground Truth Used

The ground truth used would be based on:

Engineering specifications: For pulse width, amplitude, frequency response, detection ranges, angular tolerance.
Direct measurement: For physical verification on bench-top and cadaveric models.
Predicate device performance: The "met or exceeded the performance of the predicate device" implies the predicate device's known and validated performance serves as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device is a neurophysiological monitoring system with specific algorithms described (EMG, MEP, SSEP, Guidance, Bendini). The document does not indicate that this system uses machine learning or deep learning algorithms that require a "training set" in the conventional sense. The algorithms listed are likely rule-based or signal processing algorithms, not models that are "trained" on large datasets.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no indication of a machine learning training set. The algorithms are either identical to the predicate or have modified stimulation parameters or additional baseline algorithms/views (as noted for MEP and SSEP), suggesting design changes rather than a new machine learning model requiring a training phase.

Summary

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Re:

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

March 27, 2015

Nuvasive, Incorporated Jeremy Markovich Associate Manager, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121

K143641 Trade /Device Name: NuVasive® NVM5® System Common or Usual Name: Neurological surgical monitor; Stereotaxic Instrument Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator; Evoked response electrical stimulator; Neurological stereotaxic instrument; Electromyography (EMG) monitor/stimulator Device Class: Class II Product Code: PDQ, ETN, GWF, HAW, IKN, OLO Dated: February 23, 2015 Received: February 24, 2015

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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,

Felipe Aquel - S

Carlos L. Peña, PhD, MS for Carlos Esfor 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)

K143641

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image is a 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.

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: December 19, 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) - K141968.

D. Device Description

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Image /page/4/Picture/0 description: The image shows the Nuvasive logo. 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, with the word "Speed" fading into the word "of".

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.

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 angular assessment tool
o Additional mobile application for angular assessment option

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Image /page/6/Picture/6 description: The image shows the logo for NUVASIVE. The logo is oriented vertically, with the company name stacked on top of the slogan "Speed of Innovation". Below the text is a stylized graphic element in purple and gray.

Specification/Property	Predicate DeviceNuVasive NVM5 System (K141968)	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 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 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 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 instructions1
Specification/Property	Predicate DeviceNuVasive NVM5 System (K141968)	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	$\pm$ 0.5µV to $\pm$ 8mV	$\pm$ 0.5µV 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 (K141968)	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 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

Comparison of Technical Characteristic Table 1 –

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NUVASIVE:

510(k) Premarket Notification
NuVasive® NVM5® System

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NUVASIVE 트

510(k) Premarket Notification
NuVasive® NVM5® System

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Specification/Property	Predicate DeviceNuVasive NVM5 System (K141968)	SSEP	Remote Reader	Subject DeviceNuVasive NVM5 System
Types of Modes	Manual Stimulation			Manual Stimulation
Threshold Valuesfor Color Alerts	Yes			Yes (Identical to predicate)
Audio feedback	Yes			Yes
Screen-sharingaccessibility	Remote Monitoring		Remote Monitoring	Remote Monitoring
Clinical Use		GuidanceRequires 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		YES
User Interface	Touch screen, graphical user interface and audio	Touch screen, graphical user interface and audio		Touch screen, graphical user interface and audio
Components		Bendini		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		YES
Instrumentation				IR Digitizer (with integrated passive spheres)Rod BenderMobile application

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Image /page/10/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, and the tagline "Speed of Innovation" in a smaller font below the company name. The logo is clean and modern, and the colors are eye-catching.

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 inouts, 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.