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The REMI Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted. REMI consists of Epilog disposable Sensors - a single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REM-Mobile software and REMI-Tablet are intended to receive and transmit data from four Epilog Sensors to secure cloud storage for subsequent viewing and reviewing of EEG on third-party software.

REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professional healthcare facility environment.

Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).

Device Description

REMI amplifies the electroencephalogram (EEG) from a patient's scalp. After amplification, the EEG are sent to the REMI-Tablet running the REMI-Mobile Application. REMI-Mobile combines the EEG from four Epilog Sensors and patient information and relays the data to a cloud server running Persyst software. The EEG data is accessible through the Persyst Mobile interface. REMI is designed for use with adult and pediatric patients (6+). The user interface for the REMI-Tablet is an 10" LCD touchscreen display.

The user interface for Epilog Sensors is a single button kevpad overmolded in each Sensor, REMI-Tablet power is through A/C adapter as well as limited onboard rechargeable battery. Epilog Sensor power is through a single-use primary coin cell. Using its wireless link, the Epilog Sensors can exchange EEG data and commands with the REMI-Mobile application running on the REMI-Tablet.

REMI has three major components:

Epilog-D disposable EEG sensors,
REMI-Mobile - mobile OS application designed to run on a medical-grade tablet, acquire EEG data transmitted from Epilog devices along with user-entered patient and device information, and then transmit the EEG data and patient/device information via wireless encrypted WiFi to.
REMI-Cloud – A HIPAA-compliant cloud storage and data processing platform where data is processed into a format that a FDA-cleared (K171184) EEG reviewing software called Persyst can use, which will allow remote neurological review.

AI/ML Overview

The firm Epitel, Inc. did not conduct a clinical study to prove the device meets acceptance criteria. Instead, they performed non-clinical performance testing and biocompatibility testing. The device is a physiological signal monitor and does not make diagnoses or recommendations. Therefore, the information provided below is a summary of the non-clinical and biocompatibility tests performed.

1. A table of acceptance criteria and the reported device performance

Test Category	Acceptance Criteria	Reported Device Performance
Non-Clinical Testing
Electrical Safety	Compliance with IEC 60601-1 (General requirements for safety of medical electrical equipment)	Compliance was demonstrated.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 (EMC - Requirements and Tests)	Compliance was demonstrated for both emissions and immunity.
Electroencephalograph Specific Safety	Compliance with IEC 60601-2-26 (Particular requirements for the safety of electroencephalographs)	Compliance was demonstrated.
FCC/IC Intentional Radiator	Compliance with FCC Part 15 Radiated Emissions and Class B Conducted Emissions	Compliance was demonstrated.
Biocompatibility Testing
Irritation	Verified through testing per ISO 10993-10:2010	Testing was performed per ISO 10993-10:2010, verifying biocompatibility. The Epilog Sticker was tested for prolonged (>24 hour but 24 hour but 24 hour but

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