(152 days)
The C2 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal nerve roots. The C2 NerveMonitor device with the interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device.
Indications for C2 NerveMonitor System Monitoring Procedures include: Extracranial, Intratemporal, Extratemporal, Neck Dissections, and Upper and Lower Extremities.
Indications for C2 NerveMonitor System monitoring of Spinal procedures include: Degenerative Treatments. Pedicle Screw Procedures, Fusion Cages, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures.
The system is not intended for monitoring life preserving functions. The system may not be used for diagnosing brain death.
The C2 NerveMonitor System performs intraoperative neurophysiologic monitoring (IONM) for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal nerve roots. The C2 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device. The system is not intended for monitoring life preserving functions.
The subject device stimulates for evoked responses, records, measures, and provides visual and auditory outputs for the physiological responses received from the patient. The response signals may be stimulated evoked responses or spontaneous electrophysiological action potential signals. The subject software calculates the signal amplitude and latency. The subject device provides a visual display and auditory tones corresponding with the actions performed or signals received. The waveforms are stored in the device internal memory. The user may review the signals after surgery in printed or electronically exported report formats.
The C2 NerveMonitor System consists of 4 and 8 Channel C2 NerveMonitor consoles and an optional iPad application as subject of this submission. The system also includes stimulation probe and recording electrodes, laser printer, adapter box, cables, WiFi router, sterile iPad cover, mute sensor, footswitch, and keyboard accessories that are not subject to this submission.
The C2 NerveMonitor consoles consist of software, hardware, and electrical components. The software has been updated and is subject to this submission. The software updates introduce optional device connectivity and the signal peak detection algorithm. The connectivity allows for Hospital Information System (HIS) Ethernet network interface, and wireless connection via iPad application. The signal peak detection algorithm supports channel select, synthetic sound, and quantitative measurements displayed during signal receipt features.
The document indicates that modifications to the C2 NerveMonitor System primarily involve software updates, specifically introducing optional device connectivity and a signal peak detection algorithm. The provided text primarily describes the non-clinical verification and validation performed on these software changes.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| System Level Software | Verification activities performed. |
| EMG Record Triggered Peak Detection | Verification performed. |
| Peak Detection Validation | Validation performed. |
| HL7 Integration | Verification performed. |
| Off-the-shelf NetOp OnDemand Software | Qualification performed. |
| Software Update | Verification performed. |
| Factory Settings | Verification performed. |
| Overall Performance | Performed to evaluate software and electrical components. Results confirm that the subject device performs as intended after the changes. |
Statement on meeting criteria: The document explicitly states: "The verification and validation testing results demonstrate all requirements were fulfilled. The software testing was performed with the latest software version 3.0, and on production equivalent versions of the C2 NerveMonitor. The testing was relevant and the results met the pre-defined acceptance criteria. The testing results confirm the changes meet the pre-defined specifications and do not raise different questions of safety and effectiveness for the subject devices."
2. Sample sized used for the test set and the data provenance:
The document does not explicitly mention "sample size" in terms of number of patient cases or data points for a specific test set. The testing described is software verification and validation.
- Test Set Size: Not explicitly stated in terms of patient data. The testing was performed on "production equivalent versions of the C2 NerveMonitor" with the latest software version 3.0.
- Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical, related to software functionality and system performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing described is non-clinical software verification and validation, not clinical performance evaluation requiring expert ground truth in a diagnostic sense.
4. Adjudication method for the test set:
Not applicable, as this was non-clinical software testing, not a clinical study requiring adjudication of patient outcomes or assessments.
5. Multi reader multi case (MRMC) comparative effectiveness study:
No, an MRMC comparative effectiveness study was not done. The document states: "Clinical testing was deemed not required to support the safety and effectiveness of the subject device for the intended use."
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study:
Yes, the testing performed was primarily a standalone evaluation of the modified software and the overall system's functionality. The focus was on verifying that the software updates (connectivity and peak detection algorithm) and overall system performance met predefined specifications in a non-clinical setting.
7. Type of ground truth used:
For the software verification and validation, the 'ground truth' was based on the predefined specifications and requirements of the software and system design. The testing ensured that the implemented changes behaved as expected according to these engineering and functional specifications.
8. Sample size for the training set:
Not applicable. This document describes software updates to an existing medical device and the associated verification and validation. It does not refer to a machine learning algorithm that would require a "training set" for model development. The "signal peak detection algorithm" mentioned is part of the software logic, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable, as there was no training set for a machine learning model.
§ 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.