REMI AI Discrete Detection Module
Epitel, Inc.The REMI AI Discrete Detection Module (REMI-AI DDM) is a software tool designed to assist physicians qualified in EEG interpretation by automatically identifying and marking sections of EEG recordings that may correspond to seizure-like events. It processes previously acquired EEG data collected via the REMI Remote EEG Monitoring System, helping speed up and improve the review process for EEG data in patients aged 6 years and older. The software does not provide diagnostic conclusions but serves as an aid to clinicians in seizure detection support.
Intended Use
Indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings to mark sections that may correspond to potential electrographic seizures lasting at least 10 seconds. Intended for use by physicians qualified in EEG analysis as an aid during EEG review for adult and pediatric patients (6+ years). Does not provide real-time marking or diagnostic conclusions.
Technology
Software as a medical device (SaMD) analyzes previously acquired 4-channel EEG data collected bilaterally from frontal and temporoparietal scalp regions via REMI sensors. It automatically identifies and annotates regions that may correspond to electrographic seizures lasting at least 10 seconds to assist physicians in EEG review.
Performance
The device underwent software verification, clinical validation, and human factors validation. Clinical validation showed a sensitivity of 86.2% for detecting electrographic seizures with a false alarm rate of 0.162 false positives per hour, demonstrating safety and effectiveness for its intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/16/2023
6 months - 2
FDA Approval
1/3/2024
Other devices from Epitel, Inc.
- REMI-AI Rapid Detection Module (REMI-AI RDM)2024 • 510K
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