(149 days)
The Neurosign® V4 Intraoperative Nerve Monitor is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal nerve roots.
Indications for Neurosign® V4 EMG Monitoring Procedures include: Intracranial, Extracranial, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.
Indications for spinal procedures which may use Neurosign® V4 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery and Open and Percutaneous Lumbar Procedures.
The Neurosign® V4 Intraoperative Nerve Monitor is a multi-channel nerve monitor designed for use in Ear, Nose and Throat (ENT) surgery and neurosurgery.
Using needle or surface electrodes connected to the Pre-Amplifier Pod, the nerve monitor detects electromyographic (EMG) signals within muscles caused by the contraction of the muscle due to mechanical manipulation or electrical stimulation of the nerve controlling it. The Neurosign® V4 then amplifies the EMG data into an audible signal and displays the data as a waveform on the active monitoring screen.
The Neurosign® V4 is an integrated system consisting of a combination of hardware, software, and accessories.
The Neurosian® V4 is comprised of following four components:
- Neurosign® V4 Intraoperative Nerve Monitor
- Neurosign® V4 Pre-Amplifier Pod 4 Channel
- Neurosign® V4 Stimulator Pod
- Neurosign® V4 Mute Sensor
The Neurosign® V4 Intraoperative Nerve Monitor (IONM) includes a user interface comprised of an audio output, a color graphics display with a touch screen and dedicated rotary controls for frequently adjusted parameters.
EMG signals are collected from the patient using needle and surface electrodes. The Neurosign® V4 Pre-Amplifier Pod collects, processes and transmits the EMG signals to the IONM for display and for an audio output.
The Neurosign® V4 Stimulator Pod allows the simultaneous connection of two stimulating probes for the mapping and locating of nerves within tissue, and to test the nerve activity at various stages during surgery.
The provided text describes the regulatory clearance of the Neurosign® V4 Intraoperative Nerve Monitor, primarily through demonstrating substantial equivalence to predicate devices, rather than an AI-driven device requiring extensive ground truth establishment and MRMC studies.
Therefore, many of the requested elements for an AI/ML-driven device evaluation, such as sample sizes for training/test sets, expert qualifications for ground truth, adjudication methods, and MRMC study details, are not applicable or detailed in this document. The document focuses on demonstrating that the new device performs similarly and is as safe and effective as existing legally marketed predicate devices through non-clinical testing and comparisons of technological characteristics.
However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets those criteria based on the provided text, primarily under the "Non-Clinical Testing" section.
Acceptance Criteria and Device Performance Study for Neurosign® V4 Intraoperative Nerve Monitor
This submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics for an AI/ML algorithm. The "acceptance criteria" are implied by compliance with recognized standards and performance parity with predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Test Method Summary | Reported Device Performance |
|---|---|---|
| Electrical Safety & Mechanical Safety | IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | A sample Neurosign® V4 tested and found compliant by independent test laboratory Element Materials Technology. |
| Electromagnetic Compatibility (EMC) | EN 60601-1-2: 2007 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) | A sample Neurosign® V4 tested and found compliant by independent test laboratory Kiwa Blackwood Compliance Laboratories. (Note: EN 60601-1-2 (2007) is equivalent to FDA recognized standard IEC 60601-1-2). |
| Alarm Systems | IEC 60601-1-8 (Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) | A sample Neurosign® V4 tested and found compliant by independent test laboratory Element Materials Technology. |
| Biocompatibility (for patient-contacting components) | ISO 10993-1:2009 (Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process) | |
| ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | ||
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Samples of materials for Stimulator Pod, Pre-Amplifier Pod, and connecting leads (which may contact patient) tested and found compliant by independent test laboratories Harlan Laboratories Ltd and Envigo Research Ltd. (Note: The main device is not intended for patient contact). | |
| Amplifier - EMG Acquisition & EMG Display Equivalence | Using a function generator, a range of input voltages at a set frequency were applied to both Neurosign® V4 and predicate device (NIM-Response 3.0) to replicate an EMG signal. | Measured EMG responses on both devices are within 5% of the target input and ±1% of each other, demonstrating equivalence and performance as well as or better than the predicate. |
| Stimulator Equivalence (Output Current) | 1kΩ Resistor connected across stimulator output terminals; oscilloscope used to measure potential difference across resistor. A range of input currents used to compare output waveforms and relative amplitude of Neurosign® V4 vs. NIM-Response 3.0. | Testing demonstrated almost identical stimulator performance between Neurosign® V4 and NIM-Response 3.0, demonstrating equivalence and performance as well as or better than the predicate. |
| Stimulator Equivalence (Pulse Width) | 1kΩ Resistor connected across stimulator output terminals; oscilloscope used to measure stimulator pulse width. A range of pulse width settings chosen as representative of typical use for Neurosign® V4 vs. NIM-Response 3.0. | Testing demonstrated almost identical stimulator pulse width performance between Neurosign® V4 and NIM-Response 3.0, demonstrating equivalence and performance as well as or better than the predicate. |
| Software Verification & Validation | Software documentation provided for a "major" level of concern. Standards and testing not explicitly detailed in this summary. | Software performs as intended and in accordance with specifications. Risks identified, assessed, and mitigated to an acceptable level as per ISO14971. |
| Overall Substantial Equivalence to Predicate Devices | Comparison of intended use, indications for use, technological characteristics, and principles of operation to predicate devices (NIM 3.0 and Neurosign® 400). | Intended use and indications for use of Neurosign® V4 are a subset of the primary predicate device. Technological characteristics and principles of operation are equivalent. Non-clinical test data demonstrates safety and effectiveness comparable to predicate devices. Concluded to be substantially equivalent. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Testing: The document refers to "A sample Neurosign® V4" being tested for electrical safety, EMC, and alarm systems. For biocompatibility, "Samples of these materials" were tested. For amplifier and stimulator equivalence, the testing was done by comparing the Neurosign® V4 directly against the predicate device (NIM-Response 3.0) using function generators and oscilloscopes, not patient data. Therefore, the "sample size" is effectively one device model, and samples of materials/components, tested under controlled laboratory conditions against various standard requirements.
- Data Provenance: This is a non-clinical, laboratory-based study. The data is generated from controlled tests of the device's hardware and software components against international standards and in direct comparison with a predicate device. There is no mention of human (patient) data or geographical origin of such data. This is retrospective in the sense that it evaluates the manufactured device against pre-defined performance and safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- N/A. This submission does not involve clinical data or deep learning models requiring "ground truth" established by human experts in the typical sense of AI/ML device evaluations. The ground truth for the non-clinical tests is based on the specifications of the standards (e.g., IEC 60601-1) and the measured performance of the predicate device. The testing was performed by "independent test laboratories" (e.g., Element Materials Technology, Kiwa Blackwood Compliance Laboratories, Harlan Laboratories Ltd, Envigo Research Ltd), implying their expertise in medical device testing and regulatory compliance.
4. Adjudication Method for the Test Set
- N/A. Since there's no qualitative assessment of clinical data by multiple readers, an adjudication method is not applicable. The tests are quantitative measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not conducted as this device is not an AI/ML diagnostic aid intended to improve human reader performance on medical images. It is an intraoperative nerve monitor, and its safety and effectiveness were demonstrated through engineering (non-clinical) tests and substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in spirit. The performance evaluation for the amplifier and stimulator equivalence was a "standalone" evaluation of the device's electrical characteristics. The software verification and validation are also a standalone assessment of the device's algorithmic performance. However, this is not an "algorithm only" study in the context of an AI/ML diagnostic device, but rather the performance of an integrated hardware and software system.
7. The Type of Ground Truth Used
- Engineering Specifications and Predicate Device Performance: The "ground truth" used for testing was primarily:
- Compliance with specific international standards (e.g., IEC 60601-1, EN 60601-1-2, IEC 60601-1-8, ISO 10993 series).
- The measured electrical output and signal processing characteristics of the legally marketed predicate device (NIM-Response 3.0). The acceptance criteria for the Neurosign® V4's performance were defined as being "within 5% of the target input and ±1% of each other" when compared to the predicate for EMG acquisition, and "almost identical" for stimulator performance.
8. The Sample Size for the Training Set
- N/A. This device does not employ a machine learning model that requires a training set in the typical sense. Its functionality is based on established electrophysiology principles and pre-programmed algorithms, not data-driven learning.
9. How the Ground Truth for the Training Set was Established
- N/A. As no training set was used, this question is not applicable.
§ 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.