Search Results

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.

The NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover, a Twitch Test function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.

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

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

The NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.

The provided 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.

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.

Ask a specific question about this device

The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial or lumbar motor evoked potential (MEP), or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.

• o XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.
• Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
• . Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
• Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
• . MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
• SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.
• Remote Reader The Remote Reader function provides real time remote access to the ● NVM5 System for a monitoring physician outside of the operating room.
• Guidance The Guidance function is intended as an aid for use in either open or ● percutaneous pedicle cannulation procedures in the lumbar and sacral spine (L1-S1) of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the angulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.
• Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

The NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover, a Twitch Test function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.

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

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

The NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.

The provided text describes 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

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.

Ask a specific question about this device

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. NVMS 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 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 NVMS System for a monitoring physician outside of the operating room.

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

· Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

The NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover, a Twitch Test function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.

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

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

The NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.

Here's a summary of the acceptance criteria and the study that proves the NuVasive NVM5 System meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device (K123307, also a NuVasive NVM5 System) rather than defining explicit quantitative acceptance criteria as might be seen for a novel device. The "acceptance criteria" are implied by the claim of substantial equivalence and meeting design specifications.

2. Sample Sizes Used for the Test Set and Data Provenance

The document describes "Nonclinical testing" including "NVM5 System Verification and Validation Testing," "NVM5 System software Regression Testing," "Bendini System Integration Testing," "Dual Surface Electrode Functional Testing," and "ISO 10993 Biocompatibility Testing."

• Sample Size for Test Set: The exact sample sizes for each of these nonclinical tests are not specified in the provided text. The testing focuses on system-level verification and validation.
• Data Provenance: The studies are described as "Nonclinical testing" and internal "verification and validation testing." There is no mention of data provenance in terms of country of origin or whether it was retrospective or prospective clinical data, as this was primarily a technical and software update submission, not a new clinical study.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of clinical accuracy or interpretation during these nonclinical tests. The tests performed are engineering-focused:

• Software verification against specifications.
• Regression testing to ensure changes didn't break existing functionality.
• Integration testing.
• Functional testing of a component (Dual Surface Electrode).
• Biocompatibility testing against ISO standards.

For such tests, "ground truth" would typically refer to the expected outputs or behavior defined by the design specifications or established by standard test methods.

4. Adjudication Method for the Test Set

Since the testing described is nonclinical performance, software, and biocompatibility testing, an adjudication method in the sense of reconciling expert opinions on clinical cases (e.g., 2+1, 3+1) is not applicable and not mentioned in the document. The tests would likely have pass/fail criteria based on predefined engineering or regulatory standards.

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

A MRMC comparative effectiveness study was not done or mentioned. The submission is focused on demonstrating substantial equivalence through nonclinical performance and software testing for a modified device, not a comparative clinical study with human readers.

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

The studies described are primarily standalone testing of the device's functions and components, rather than human-in-the-loop performance. The "human-in-the-loop" aspect is implicit in the intended use where the device provides information to the surgeon for assessment. The software and hardware functionalities were tested independently to ensure they meet specifications and perform as expected.

7. Type of Ground Truth Used

The ground truth used for the nonclinical tests would be:

• Design Specifications: For the NVM5 System Verification and Validation and Software Regression Testing, the "ground truth" would be the predefined Software Requirements Specifications.
• Predicate Device Performance: For demonstrating substantial equivalence, the "ground truth" is the established performance and characteristics of the predicate NuVasive NVM5 System (K123307).
• Standard Test Methods: For Biocompatibility Testing, the "ground truth" is defined by the ISO 10993 standards and their acceptance criteria.
• Expected Functional Output: For Bendini System Integration Testing and Dual Surface Electrode Functional Testing, the "ground truth" would be the expected functional outputs and interactions defined by the system design.

8. Sample Size for the Training Set

The document does not provide information about a specific "training set" or its sample size. This type of information is typically relevant for submissions involving machine learning algorithms that are trained on data. While the NVM5 System contains "algorithms," they are described as "identical algorithms as predicate," implying established, deterministic algorithms rather than newly trained AI models. The testing described is verification and validation of these established algorithms and the system as a whole.

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

As no specific "training set" for machine learning is mentioned, the method for establishing its ground truth is not applicable and not described in this document.

Ask a specific question about this device

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 motor evoked potential (TceMEP) 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 displayinq 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.
• TcMEP - Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The TcMEP 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 (L 1-S1) of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the anqulation 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.

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 motor evoked potential (TcMEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover, a Twitch Test ("Train of Four") 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 (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVM5 System includes the following six (6) software functionalities / modalities:

1. Electromyography (EMG)
2. Transcranial Motor Evoked Potential (TceMEP), or simply MEP
3. Somatosensory Evoked Potential (SSEP)
4. Guidance
5. Bendini
6. Remote Monitoring
   The NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.

The NuVasive® NVM5® System is intended for intraoperative neurophysiologic monitoring during spinal surgery. The system provides information to the surgeon to assess a patient's neurophysiologic status by electrically stimulating nerves and monitoring electromyography (EMG), transcranial motor evoked potential (TceMEP), or somatosensory evoked potential (SSEP) responses. It also includes Bendini™ software for locating spinal implant instrumentation for rod placement.

The FDA 510(k) submission (K123307) dated March 15, 2013, concludes that the NuVasive® NVM5® System is substantially equivalent to legally marketed predicate devices based on indications for use, technological characteristics, and performance testing.

Here's the breakdown of the acceptance criteria and the study that demonstrates the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are primarily based on demonstrating substantial equivalence to predicate devices across various technical specifications and functionalities. The reported device performance is presented as a comparison between the subject NVM5 System and its predicate devices, where "YES" indicates substantial equivalence.

Note: The document does not provide specific quantitative acceptance criteria or numerical performance metrics for each function (e.g., a specific accuracy percentage for nerve detection as an absolute requirement set beforehand). Instead, it relies on demonstrating that the performance of the NVM5 System is comparable to or better than previously cleared predicate devices through verification and validation testing, and compliance with recognized standards.

2. Sample Size Used for the Test Set and Data Provenance

The document primarily refers to "nonclinical testing" and "verification and validation testing" for the NVM5 System. For the Guidance function, it explicitly mentions:

• Data Provenance: Clinical literature data. The references provided are from "J Neurosurg Spine, 2010" and "J Neurosurg Spine, 2009," suggesting the data would be retrospective and likely from various countries (though not specified, spine surgery research is often international).
• Sample Size: The document does not specify the sample size for the test set from these literature studies, nor does it provide a direct test set for the NVM5 System's Guidance functionality beyond comparing its performance to that presented in existing literature.

For the Bendini function, "nonclinical testing included evaluation of software performance per predetermined specifications outlined in the SRS." This indicates internal testing, but no sample size or data provenance (e.g., patient data) is provided.

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

For the Guidance function, since the evaluation points to existing clinical literature, the "ground truth" would have presumably been established within those studies (e.g., confirmation of screw placement accuracy by post-operative imaging or surgical observation). The document does not specify the number or qualifications of experts involved in establishing this ground truth within the cited literature or for the NuVasive's internal comparison.

For other functions and general verification and validation, the document does not specify the number or qualifications of experts. Such testing typically involves engineers, quality assurance personnel, and potentially clinical consultants, but no details are provided here.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for any test set. Given the reliance on nonclinical testing and comparison to literature for the Guidance function, a formal adjudication process akin to those for AI clinical studies is not detailed.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The assessment focuses on the device's technical specifications and substantial equivalence to predicates, not on improvements in human reader performance with or without AI assistance. The NVM5 System itself is a surgical monitoring and guidance device, not primarily an AI-driven diagnostic imaging interpretation tool that would typically undergo MRMC studies.

6. Standalone (Algorithm Only) Performance Study

The document refers to "nonclinical testing" and "verification and validation testing" which implies standalone testing of the algorithm (software) components. For example:

• "NVM5 System Verification and Validation Testing"
• "NVM5 System software Regression Testing"
• "Nonclinical testing performed for the Bendini function included evaluation of software performance per predetermined specifications outlined in the SRS. GUI functionality, error handling, system accuracy during data acquisition, verification of instrument performance in combination with the software, and verification of software algorithms."

These statements suggest that the algorithm's performance was tested independently of direct human-in-the-loop clinical use, but the nature and scope of these standalone tests are not detailed beyond meeting predetermined specifications.

7. Type of Ground Truth Used

• For the Guidance function, the "ground truth" implicitly relies on the confirmed accuracy of pedicle screw placement as reported in the referenced clinical literature. This would typically be based on post-operative imaging outcomes data (e.g., CT scans reviewing screw position).
• For other nonclinical and software verification tests (e.g., Bendini, General NVM5 functions), the ground truth would be based on predetermined specifications and expected system outputs. For example, an electrical stimulation test would have a known target response, or software algorithm verification would test against a predefined correct output for a given input.

8. Sample Size for the Training Set

The document does not specify any training set sample size. The NVM5 System is a medical device for intraoperative monitoring and surgical guidance. While it employs software and algorithms, the filing describes it in terms of "substantial equivalence" to existing technologies rather than as a machine learning/AI device requiring distinct training and test sets in the modern sense. The algorithms are likely rule-based or signal processing-based, rather than learned from large datasets.

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

As no training set is described, there is no information on how ground truth was established for a training set. The nature of the device (monitoring and guidance, rather than pattern recognition from large image sets) suggests that the "ground truth" for its development would be based on established neurophysiological principles, biomechanical models, and engineering specifications, rather than labeled training data.

Ask a specific question about this device

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 motor evoked potential (TcMEP) or somatosensory evoked potential (SSEP) responses of nerves.

• 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 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.
• TcMEP Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The TcMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord 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 spine 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.

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 motor evoked potential (TcMEP) or somatosensory evoked potential (SSEP) responses of the muscle groups imnervated by the nerves. Moreover, a Twitch Test ("Train of Four") 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. Lastly, the system also offers an optional screen sharing application (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVMS System includes the following five (5) software functionalities / modalities: 1. Electromyography (EMG) 2. Transcranial Motor Evoked Potential (TcMEP), or simply MEP 3. Somatosensory Evoked Potential (SSEP) 4. Remote Monitoring 5. Guidance. The NVM5® System hardware consists of a Patient Module (PM) and a Control Unit (CU) comprised of an embedded computer with touch screen controls and an interface card, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.

The NuVasive NVM5 System is a medical device intended for intraoperative neurophysiological monitoring during spinal surgery. The system provides information directly to the surgeon to help assess a patient's neurophysiologic status by electrically stimulating nerves and monitoring electromyography (EMG), transcranial motor evoked potential (TcMEP), or somatosensory evoked potential (SSEP) responses of nerves.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the acceptance criteria and reported device performance by comparing the NuVasive NVM5 System with predicate devices. The primary method for demonstrating acceptance is through substantial equivalence to legally marketed predicate devices, supported by nonclinical performance testing.

Conclusion on Equivalence: The document states "Yes – the Guidance function has limited indications compared to the predicate. The reduced degree of data collected by Guidance is still deemed substantially equivalent since it is used in conjunction with fluoroscopic imaging, not indicated for used by the predicate StealthStation. The amount of data collected by Guidance is sufficient to provide angular outputs to compare against the angular inputs identified by the user as the planned trajectory, considering that intraoperative radiographic imaging is used to confirm the starting point and correct trajectory of the cannulation needle." This indicates the device meets the criteria for its specified (more limited) use.

Performance Data for other functionalities (EMG, TcMEP, SSEP, accessories): Demonstrated through compliance with IEC 60601-1, IEC 60601-2-40, IEC 60601-1-2, and various accessory-specific tests (impedance, current density, electrical performance, biocompatibility, sterilization, penetration/friction).

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state a sample size for a test set in the conventional sense of a clinical study with patients. The performance data primarily relies on:

• Nonclinical Bench Testing: This includes electrical safety, compatibility, impedance, current density, electrical performance, durability, fluid interference, biocompatibility, sterilization validation, penetration, and friction testing. These tests are typically conducted in a laboratory setting.
• Comparison to Predicate Devices: The primary method for proving substantial equivalence.
• Reference to Published Clinical Literature: For the Guidance performance testing, two published clinical literature articles are referenced:
  • "Accuracy of percutaneous lumbar pedicle screw placement using the oblique or 'owl's-eve' view and novel guidance technology" (J Neurosurg Spine. 2010)
  • "Improving accuracy and reducing radiation exposure in minimally invasive lumbar interbody fusion" (J Neurosurg Spine, 2010)"

The document does not provide details on the data provenance (e.g., country of origin, retrospective or prospective) for any clinical data that might have contributed to these published works, nor does it specify if a dedicated prospective test set was used for the NVM5 System itself beyond the bench testing.

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

This information is not provided in the document. The document describes nonclinical performance testing and refers to published clinical literature, but it does not detail the methodology for establishing ground truth or the involvement/qualifications of experts in the context of a "test set" for the NVM5 device.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the testing primarily involves nonclinical bench tests and comparison to predicate devices, a formal adjudication method for a "test set" in the context of clinical ground truth is not described.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The device is for intraoperative neurophysiological monitoring and guidance, which directly provides information to the surgeon. It is not an AI-assisted diagnostic imaging interpretation tool where human readers assess cases with and without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes the performance of the NVM5 System as a device providing information to the surgeon for intraoperative neurophysiologic monitoring and guidance. The "Guidance" function explicitly states it is "an aid for use... when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the angulation..." This indicates it's designed to be used with a human (surgeon) in the loop and does not refer to a standalone, algorithm-only performance assessment in the absence of human interaction or interpretation.

7. The Type of Ground Truth Used

For the Guidance function's accuracy testing, the ground truth appears to be based on:

• Engineering measurements: Demonstrating "equivalent degrees of variance" between the accelerometer-based NVM5 Guidance function and the infrared tracking from the StealthStation predicate device.
• Clinical Outcomes from Literature: Supplemented by the results from two referenced clinical literature articles concerning the accuracy of pedicle screw placement and radiation exposure in minimally invasive lumbar interbody fusion. While these articles would have used surgical outcomes or imaging (e.g., post-op CT) to establish ground truth for screw placement accuracy, the specific ground truth methodology for these studies is not detailed in the 510(k) summary itself.

For other functions (EMG, TcMEP, SSEP), the ground truth is implicitly established through:

• Compliance with electrical safety and performance standards (IEC 60601-x series): This ensures the device reliably measures and stimulates as expected for neurophysiological monitoring.
• Bench testing of accessories: Ensures components meet specifications for electrical properties, biocompatibility, and sterilization.

8. The Sample Size for the Training Set

The document pertains to a 510(k) submission for a medical device that monitors neurophysiological responses and aids in surgical guidance. It does not describe a machine learning or AI algorithm in a way that would involve a distinct "training set." Therefore, a sample size for a training set is not applicable and not provided.

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

As there is no mention of a machine learning or AI algorithm requiring a training set, the establishment of ground truth for such a set is not applicable and not provided. The ground truth for the device's performance, as described, is based on engineering principles, compliance with medical device standards, and substantial equivalence to established predicate devices.

Ask a specific question about this device