(796 days)
Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient's neurophysiological status.
The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways.
It is provided in III different configurations:
I. 32/B
II. 32/S
III. 16/S
The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (auditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed.
The system is not intended to measure the vital signs. It records the data to be interpreted by the neuromonitoring specialist.
Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient's neurophysiological status.
The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations:
I.32/B 32/8 II. III. ાર્ભદ્ર
The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (auditory evoked potentials), VEP (visual evoked potentials, direct cortical stimulation. Also, the train-of-four (TOF) stimulation is performed.
The system is not intended to measure the vital signs. It records the data to be interpreted by the neuromonitoring specialist.
The systems can be used in operating rooms, intensive care units of different health care facilities (including clinics, hospitals, health centers, ambulance centers, etc.), specialized medical facilities (including prevention centers, medicine centers for emergency, military and medical expertise centers), research and educational medical and biological facilities where the neuromonitoring is required, only by qualified operators who have received training on these devices.
The provided text is an FDA 510(k) summary for the Neuro-IOM system. It details the device's technical specifications and compares them to a predicate device (Xltek Protektor 32) to demonstrate substantial equivalence, rather than providing the results of a specific clinical study with defined acceptance criteria and human reader performance.
Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert ground truth, and MRMC studies are not present in this document because they are not typically required for a 510(k) clearance based on substantial equivalence for this type of device. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate through non-clinical testing and comparison of specifications.
However, I can extract the information that is available and note what is not provided.
Acceptance Criteria and Device Performance:
The document does not present specific "acceptance criteria" for a clinical performance study in the typical sense of metrics like sensitivity, specificity, accuracy, or AUC. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, primarily through comparison of technical specifications and non-clinical performance testing (biocompatibility, electrical safety, EMC, performance tests, and software verification/validation).
The "reported device performance" is demonstrated by showing that the Neuro-IOM system's technical attributes are either identical or sufficiently similar to the predicate device, or where differences exist, they do not adversely affect safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, there isn't a direct table of clinical acceptance criteria and performance metrics. Instead, the document provides detailed comparison tables between the subject device (Neuro-IOM system) and the predicate device (Xltek Protektor 32) across various attributes. The acceptance is implied if the differences are found to not adversely affect safety and effectiveness.
Here's a summary of the technical performance comparison, which serves as the basis for the "acceptance" of substantial equivalence:
| Attribute / Characteristic | Neuro-IOM 16S, 32S, 32B (Submitted Product) | Xltek Protektor 32 (Predicate Product) | Why the differences do not adversely affect the safety and effectiveness |
|---|---|---|---|
| Intended Use | Intraoperative neurophysiologic monitoring to assess patient's neurophysiological status; monitors functional integrity/mapping of central and peripheral nervous system (motor and sensory pathways). Modalities: free-run EMG, direct nerve stimulation (pedicle screw test), SSEP, MEP, EEG, AEP, VEP, direct cortical stimulation, TOF. Not for vital signs. Records data for neuromonitoring specialist interpretation. | Intraoperative neurological monitoring using EEG, EP, EMG, and TcMEP stimulation techniques to help assess a patient's neurological status during surgery. EPWorks software allows manual configuration of parameters and creation of protocols for EEG, EP, EMG, and TcMEP waveforms. | Same (Similar overall purpose and modalities) |
| Intended User | Trained personnel only | Trained personnel only | Same |
| Device Hardware Setup | Connected to PC, not standalone | Connected to PC, not standalone | Same |
| Amplifiers - Channels | 16/32 | 16/32 | Same |
| Amplifiers - Input Impedance | >1000 MOhm | >100 MOhm | Higher impedance for Neuro-IOM improves signal quality; no adverse impact on safety/effectiveness. |
| Amplifiers - Common Mode Rejection (CMRR) | >90 dB | >93 dB | Slightly different, but both are high values. No adverse impact on safety/effectiveness (implied). |
| Amplifiers - Low Frequency Filters | 0.2 Hz - 2000 Hz | 0.1 - 500 Hz | Neuro-IOM has higher cutoff; effectively cuts off low-frequency oscillations. No adverse impact on safety/effectiveness. |
| Amplifiers - High Frequency Filters | 10 Hz - 4 KHz | 30 Hz - 15 KHz | Neuro-IOM range is sufficient for proper signal recording and eliminates high-frequency interference. Difference negligible to impact safety/effectiveness. |
| Amplifiers - Notch Filter | 50/60 Hz | 50/60 Hz | Same |
| Amplifiers - Sample Rate | 50 KHz | 60 KHz | Difference negligible to impact safety/effectiveness. |
| Amplifiers - Sensitivity | 0.05 µV/division to 20 mV/division | 0.1 µV/division to 5 mV/division | Wider range in Neuro-IOM is favorable, allowing display of lower- and higher-amplitude signals. No adverse impact on safety/effectiveness. |
| Amplifiers - Noise Level |
§ 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).