REMI-AI Rapid Detection Module (REMI-AI RDM)

Intended Use

The REMI-AI Rapid Detection Module (REMI-AI RDM) is a seizure detection module which is integrated into the REMI Remote EEG Monitoring System and is only indicated for use within non-ICU (Intensive Care Unit) healthcare settings. REMI-AI RDM has not been validated for and is not indicated for detection of electrographic status epilepticus. REMI-AI RDM conducts automated analysis of REMI EEG data in near real-time and provides notifications of potential electrographic seizures (events) through the REMI System when seizure prevalence of 10% or greater (indicating seizure activity of at least 30 seconds within a 5-minute rolling window) is detected. When seizure prevalence is displayed, the notification also displays the corresponding event detection confidence. Notifications are intended to be used by qualified clinicians who will exercise professional judgment in their application. Detected events are also annotated in the associated REMI EEG record as an aide to the qualified physician's REMI EEG review. Delays of up to several minutes may occur between the detection of an event and the generation of an event notification, and are thus not a substitute for real-time monitoring. REMI-AI RDM does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI-AI RDM is indicated for use with adult and pediatric patients (6+ years).