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The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.

The Brain Sentinel Monitoring and Alerting System is a sEMG-based system for identifying sEMG activity that may be associated with generalized tonic-clonic seizures (GTCS). The device has two main components: the sEMG monitor and the base station. The sEMG monitor is worn on the patient's upper arm and monitors EMG activity in the arm via cutaneous electrodes connected to the sEMG monitor. Upon identification of sEMG activity, the monitor communicates wirelessly to the base station, which alerts a healthcare provider or caregiver in one or more ways (e.g., audible alarm, text message, e-mail, etc.).

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for Brain Sentinel® Monitoring and Alerting System

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The study utilized a prospective, multicenter, non-randomized design.

• Total Intent to Monitor (ITM) Cohort: 199 subjects.
• Properly Placed (PP) Cohort: 149 subjects (from the ITM cohort, after excluding improper placements).
• PP Cohort with GTC Seizure (Adults): 17 subjects (who experienced 21 GTC seizures). This adult PP subset is the primary test set for the acceptance criteria.
• Data Provenance: The data was collected from eleven (11) National Association of Epilepsy Centers (NAEC) Level IV Epilepsy Centers, making it prospective and originating from multiple US-based clinical sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Three independent neurologists.
• Qualifications of Experts: The document specifies "independent neurologists" and "independent epileptologists." While specific years of experience are not provided, "Level IV Epilepsy Centers" imply highly qualified specialists in epilepsy.

4. Adjudication Method for the Test Set

A majority rules approach was taken (2 out of 3 neurologists) to identify GTC seizures from the vEEG records. For each identified seizure, the time of bilateral, appendicular, tonic extension reported by each reviewer was averaged for comparison to the device's alert time.

For device placement assessment, three independent reviewers evaluated video images. If at least two out of the three independent reviewers classified the placement as proper, the data was included in the Properly Placed (PP) cohort.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an explicit Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not reported in this document. The study focused purely on the standalone performance of the device in identifying sEMG signals associated with GTC seizures. The device alerts caregivers, implying human involvement, but the study design presented does not evaluate the change in human performance with this assistance.

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

Yes, a standalone performance study was done. The clinical study describes the device (algorithm) identifying sEMG activity and then comparing its alerts against the ground truth established by independent neurologists from vEEG records. The device's PPA and false alarm rates are calculated based on these automated alerts, indicating standalone algorithm performance. The device provides "an alarm to alert caregivers," but the performance metrics are calculated solely on the device's output.

7. The Type of Ground Truth Used

The ground truth used was expert consensus from vEEG records. Specifically, "Identification of GTC seizures was performed by three independent neurologists who reviewed the vEEG records of each subject's EMU stay to determine if and when generalized tonic clonic (GTC) seizures occurred."

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. The study describes a "clinical study" used to evaluate the device's operating characteristics. It mentions that "Recorded sEMG data was post-processed at various threshold settings," suggesting that the algorithm for seizure detection might have been developed using unseen data or iteratively refined, but a distinct "training set" size as part of the regulatory submission is not detailed. The phrase "post processing sEMG data recorded from the clinical study to determine the operating characteristics" might imply that the clinical study data itself was used for evaluating operating points, rather than a separate, prior training phase with a distinct dataset.

9. How the Ground Truth for the Training Set Was Established

As the document does not explicitly describe a separate "training set" and its size, it consequently does not detail how the ground truth for such a training set was established. If the "clinical study" data was also used for initial algorithm development or refinement, the ground truth would likely have been established similarly to the test set: expert consensus from vEEG records. However, this is inferred, not explicitly stated for a training phase.

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