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The Ceribell Status Epilepticus Monitor software is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The Ceribell Status Epilepticus Monitor software analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epileptious as defined in the American Clinical Neurophysiology Society's Guideline 14.

The diagnostic output of the Ceribell Status Epilepticus Monitor is intended to be used as an aid for determining patient treatment in acute-care environments. The device's diagnosis of Electrographic Status Epilepticus provides one input to the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient.

The Ceribell Status Epilepticus Monitor is intended for diagnosis of Electrographic Status Epilepticus only. The device does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The device is not intended for use in Epilepsy Monitoring Units.

The Ceribell Status Epilepticus Monitor is a software as medical device that analyzes EEG waveforms for the intended use of recognizing electrographic status epilepticus (ESE). The subject device software is intended for use only with the Ceribell Pocket EEG Device (K191301), which is also the predicate device. The predicate device contains a software module that performs detection of seizures in a similar manner as the subject device. The user workflow and instructions for starting an EEG recording on a patient are unchanged compared to the predicate device.

The user places the Ceribell Instant EEG Headband (K210805) on the patient, the headband contains 10 electrodes that are arranged in a bipolar montage and correspond to the following locations following the 10-20 electrode naming convention: Fp1, F7, T3, T5, O1, Fp2, F8, T3, T6, O2. The 10 electrodes form 8 channels (4 on the left hemisphere, 4 on the right hemisphere) that are analyzed by the subject device's ESE detection algorithm.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The Ceribell Status Epilepticus Monitor underwent clinical validation to assess its performance in diagnosing Electrographic Status Epilepticus (ESE). The primary performance metrics were sensitivity and specificity.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 350 subjects
• Data Provenance: Retrospective study using previously-collected EEG data from 6 hospitals of varying size and geographic locations. The data represents "real-world data" from a fixed one-year time period. All included subjects were ≥ 18 years of age.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: A team of "qualified neurologists" (specific number not given, but plural).
• Qualifications of Experts: Described as "qualified neurologists." No further details on years of experience or specific subspecialties are provided in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: "Majority opinion of the expert reviewers." This indicates a consensus-based approach. For example, if there were three reviewers, at least two would need to agree.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated as having been performed. The study focused on the standalone performance of the algorithm against expert-established ground truth.
• Effect Size of Human Readers with vs. Without AI Assistance: Not applicable, as an MRMC study with human-in-the-loop performance was not described.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the study describes the standalone (algorithm-only) performance of the Ceribell Status Epilepticus Monitor. The device algorithm was run on the collected dataset, and its output was compared against the expert-established ground truth.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus. Specifically, a "team of qualified neurologists independently review[ed] and categorize[d] each EEG; the ground-truth reference standard is established by a majority opinion of the expert reviewers."

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for the training set. The clinical validation study described is a retrospective study of the algorithm's performance on a test set (350 subjects).

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

• The document does not explicitly state how the ground truth for the training set was established, as details about the training phase itself are not provided in this summary. The focus is on the clinical validation study.

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