(207 days)
The NVJJB ™ System is a medical device that is intended for intraoperative neurophysiological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiological status. NVJJB provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG) or transcranial motor evoked potential (TcMEP) responses of nerves.
MaXcess Detection - The MaXcess Detection function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool. Difference Screw Test (DST) - The DST function allows the surgeon to locate and evaluate spinal nerves before, during, or after placement of bone screws by verifying nerve integrity and factoring it into the alarm criteria. 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. 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. Remote Reader - The Remote Reader function provides real time remote access to the NVJJB System for a monitoring physician outside of the operating room. Nerve Retractor - The Nerve Retractor function allows the surgeon to locate and identify spinal nerves by directly stimulating exposed nerves to assist in identifying neurophysiological changes during retraction.
The NVJJB® System is a medical device that is intended for intraoperative neurophysiological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiological status. NVJJB provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG) or transcranial motor evoked potential (TceMEP) responses of the muscle groups innervated 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 NVJJB System also offers an optional screen sharing application (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVJJB user interface. In summary, the NVJJB System includes the following three (3) software functionalities / modalities:
- Electromyography (EMG)
- Transcranial Motor Evoked Potential (TceMEP), or simply MEP
- Remote Monitoring
The NVJJB® 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
Here's an analysis of the provided text regarding the NuVasive® NVJJB System, focusing on acceptance criteria and the study proving it meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative performance metrics against predefined acceptance criteria for clinical outcomes. The "acceptance criteria" here are implicitly the performance standards of the predicate devices and general electrical safety and compatibility standards.
| Specification/Property | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (NuVasive NVJJB System) |
|---|---|---|
| Intended Use / Indications | Medtronic NIM Eclipse (K061113): Record, monitor, stimulate/record biopotential signals (EMG, evoked response, nerve/muscle potentials); intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction; feedback for localization/assessment of spinal nerves and verification of instrumentation placement to avoid injury. | |
| NuVasive NVM5 System (K112718): Intraoperative neurophysiologic monitoring during spinal surgery; assess patient's neurophysiologic status by electrically stimulating nerves and monitoring EMG, TcMEP, or SSEP responses. Functions include XLIF (detection) for nerve avoidance, Basic & Dynamic Screw Test, Free Run EMG, Twitch Test (Train of Four), TcMEP, SSEP, Remote Reader, and Guidance function for pedicle cannulation. | Intraoperative neurophysiological monitoring and status assessment during spinal surgery, providing information by electrically stimulating nerves and monitoring EMG or TcMEP responses. Functions include MaXcess Detection, Difference Screw Test (DST), Basic & Dynamic Screw Test, Free Run EMG, Twitch Test (Train of Four), TcMEP, Remote Reader, and Nerve Retractor. (Broadly aligns with predicate uses, without SSEP or guidance function explicitly stated). | |
| Electrical Safety Standards | IEC 60601-1 (1988), A1 (1991), A2 (1995); IEC 60601-2-40 (1988); IEC 60601-1-2 (2001), A1 (2004) | Certified to IEC 60601-1 (1988), A1 (1991), A2 (1995); IEC 60601-2-40 (1988); IEC 60601-1-2 (2001), A1 (2004) |
| Total Available Channels | NuVasive NVM5 System: 32; Medtronic NIM Eclipse: 32 | 8 |
| Frequency Response | NuVasive NVM5 System: 3 Hz to 4.8 kHz; Medtronic NIM Eclipse: 1Hz to 4 kHz | 30 Hz to 4.8 kHz |
| User Interface | NuVasive NVM5 System: Touch screen and [optional] keyboard/mouse; Medtronic NIM Eclipse: Touch screen and keyboard/mouse | Touch screen and [optional] keyboard/mouse |
| Remote Monitoring | NuVasive NVM5 System: Yes; Medtronic NIM Eclipse: Yes | Yes |
| CMRR | NuVasive NVM5 System: > 100 dB @ 60 Hz; Medtronic NIM Eclipse: > 100 dB @ 60 Hz | > 100 dB |
| A/D Sampling Rate | NuVasive NVM5 System: 9.6 kHz | 9.6 kHz |
| Max Current | NuVasive NVM5 System: 0.09 A; Medtronic NIM Eclipse: 0.1 A | 0.05 A |
| Max Pulse Width | NuVasive NVM5 System: 0.0002 sec; Medtronic NIM Eclipse: 0.0005 sec | 0.0002 sec |
| Max Number of Pulses per second | NuVasive NVM5 System: 5; Medtronic NIM Eclipse: 100 | 5 |
| Max Charge Density | NuVasive NVM5 System: 107 µC/cm²; Medtronic NIM Eclipse: 25,000 µC/cm² | 59 µC/cm² |
| Biocompatibility | ISO 10993-1 | Biocompatibility testing per ISO 10993-1 performed. (Result implicitly meets standard) |
| Sterilization Validation | ISO 11135-1 | Sterilization validation per ISO 11135-1 performed. (Result implicitly meets standard) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes nonclinical testing to demonstrate substantial equivalence and verify design specifications. It does not refer to a "test set" in the context of clinical data or patient samples. The testing relies on engineering and laboratory assessments, not a study involving human subjects or retrospective clinical data analysis for performance metrics typical of AI/diagnostic devices.
- Sample Size for Test Set: Not applicable in the context of clinical data. The "test set" consists of the device and its accessories undergoing various engineering and safety tests.
- Data Provenance: Not applicable as it's not clinical data. The tests are described as "nonclinical testing" performed by NuVasive or certified labs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, is not established for this type of nonclinical engineering and safety testing. The "ground truth" here is adherence to regulatory standards and established engineering principles.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a traditional medical device (neurological surgical monitor), not an AI/diagnostic algorithm that typically undergoes such a study to compare reader performance with and without AI assistance. The focus is on substantial equivalence to existing predicate devices based on technological characteristics and safety.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a way. The "performance data" presented is primarily a standalone assessment of the device's adherence to electrical safety standards and functional specifications in a laboratory setting. This is an "algorithm only" performance (though it's a hardware/software system, not just an algorithm) in the sense that its technical functions (e.g., frequency response, current output, CMRR) are tested intrinsically, not in conjunction with human interpretation of its outputs in a clinical scenario for effectiveness. The "Human-in-the-loop" aspect is an inherent part of its intended use (providing information to a surgeon), but the testing itself is nonclinical and standalone from human interpretation of clinical results.
7. The Type of Ground Truth Used
The "ground truth" in this submission is primarily:
- Regulatory Standards: Adherence to international electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-2-40, IEC 60601-1-2).
- Biocompatibility and Sterilization Standards: Compliance with ISO 10993-1 and ISO 11135-1.
- Engineering Specifications: The device's measured electrical and physical properties (e.g., frequency response, current output, charge density, channel count) are compared against the specifications of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set" of data in the conventional sense. Its functionality is based on established electrophysiological principles and hardware design.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.