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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).

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:

1. Epilog-D disposable EEG sensors,

2. 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.

3. 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.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This section is not applicable as no clinical study was conducted. The performance data is based on non-clinical and biocompatibility testing. The document does not specify general sample sizes (e.g., number of devices tested) for the non-clinical or biocompatibility tests, nor does it specify data provenance in terms applicable to clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as no clinical study was conducted that required ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as no clinical study was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as no clinical study, particularly an MRMC study, was conducted. The device is a physiological signal monitor and does not include AI for interpretation or diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable as the device is a physiological signal monitor and does not involve a standalone algorithm for diagnostic performance. The submission explicitly states, "REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This section is not applicable as no clinical study requiring a ground truth was performed. The non-clinical and biocompatibility testing rely on established standards and laboratory results.

8. The sample size for the training set

This section is not applicable, as no machine learning algorithm requiring a training set for diagnostic or interpretative purposes was mentioned or evaluated in the context of device performance.

9. How the ground truth for the training set was established

This section is not applicable, as no machine learning algorithm requiring a training set was mentioned or evaluated.

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