(201 days)
The REMI-AI Discrete Detection Module (REMI-AI DDM) is indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings. REMI-AI DDM is intended to be used by physicians qualified to analyze and interpret EEG who will exercise professional judgment in using the information.
As an aide to the qualified physician's REMI EEG review, REMI-AI DDM marks previously acquired sections of REMI EEG that may correspond to neurological events of interest indicative of potential electrographic seizures lasting at least 10 seconds in duration. REMI-AI DDM is indicated for use with adult and pediatric patients (6+ years).
REMI-AI DDM does not mark REMI EEG records in real time and does not provide any diagnostic conclusion about the patient's condition to the user.
REMI-Al Discrete Detection Module (REMI-AI DDM) is a software as a medical device (SaMD) that automatically identifies and annotates discrete seizure-like events in previously acquired electroencephalography (EEG) traces to aid a qualified physician in their review of REMI EEG records. REMI-AI DDM analyzes previously acquired EEG data from 4-channel recordings obtained from bilateral, bipolar scalp EEG recordings at both the frontal and temporoparietal regions, collected and stored by the REMI Remote EEG Monitoring System. REMI-AI DDM analyzes EEG recordings and detects regions of the data that may correspond to electrographic seizures lasting at least 10 seconds in duration. These regions are annotated in the REMI EEG file as discrete events and are provided to assist in REMI EEG review.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Event-Level Sensitivity > 70% | 86.2% (with a calculated 95% CI lower bound of 79.5%) Across all 31 patients with seizures. |
| Pediatric (6-21 years): 83.0% (95% CI: 73.1, 93.3) | |
| Adult (22+ years): 90.0% (95% CI: 81.5, 100.0) | |
| EMU: 87.5% (95% CI: 80.0, 94.4) | |
| Ambulatory: 80.0% (95% CI: 71.0, 100.0) | |
| False Alarm Rate (FAR) 70% | 92.2% (with a 95% CI Lower Bound of 86.5%). |
| Pediatric (6-21 years): 87.8% (95% CI: 77.0, 97.0) | |
| Adult (22+ years): 95.5% (95% CI: 90.0, 100.0) | |
| EMU: 92.2% (95% CI: 85.9, 97.3) | |
| Ambulatory: 92.5% (95% CI: 77.5, 100.0) | |
| Mean Per-Patient FAR |
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).