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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).

REMI-AI RDM conducts automated analysis of EEG data collected by the REMI System in near real-time. REMI-AI RDM provides notifications of the prevalence and confidence of potential electrographic seizures, having a combined prevalence of 10% or greater, which correlates with a duration of at least 30 seconds of activity within a rolling 5 minute window of EEG.

REMI-AI RDM notifications are presented through the REMI Mobile software application, and are intended to be used by qualified clinicians who will exercise professional judgment in their interpretation. Notifications include the prevalence and confidence value for the event and are marked in the associated EEG record in order to assist qualified clinicians in their assessment.

REMI-AI RDM notifications identify when a section of EEG is consistent with seizure characteristics it has been trained to recognize. When a notification is presented, clinical context and facility procedures should inform next steps in patient evaluation and management. REMI-AI RDM does not make any treatment or management recommendations.

Here's a summary of the acceptance criteria and study details for the REMI-AI Rapid Detection Module (REMI-AI RDM), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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