(115 days)
The C2 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and 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
Indications for C2 NerveMonitor System Monitoring Procedures include:
Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.
Indications for C2 NerveMonitor System monitoring of Spinal procedures include:
Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Procedures and Thoracic 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 is a multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying stimulus for evoked responses. The EMG activity monitoring console uses both video and audio output.
Responses monitored with the device may originate from operator applied stimulus or from direct or indirect mechanical stimulus occurring during the course of surgery.
The provided text describes the C2 NerveMonitor System, an intraoperative neurophysiological monitor. However, it does not contain specific acceptance criteria, a study that proves the device meets acceptance criteria, or details regarding the methodologies listed in your request (sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth type, training set size, and ground truth establishment for the training set).
Instead, the document is a 510(k) Summary, which is a premarket notification to the FDA. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.
The "NONCLINICAL AND CLINICAL TEST" section states:
"Preclinical testing verified the design of this device and that all specified requirements were fulfilled. The C2 NerveMonitor and all corresponding accessories are similar in their risks and benefits, as well as their manner of performance, to the predicate devices listed."
This is a general statement of verification and claims similarity to predicate devices, but it does not present the detailed information you requested about acceptance criteria and performance studies.
Therefore, I cannot populate the table or answer the specific questions because the information is not present in the provided document.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).