Search Results

The Ceribell Infant Seizure Detection Software is intended to mark previously acquired sections of EEG recordings in newborns (defined as preterm or term neonates of 25-44 weeks postmenstrual age) and infants less than 1 year of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection Software also provides notifications to the user when detected seizure prevalence is "Frequent", "Abundant", or "Continuous", per the definitions of the American Clinical Neurophysiology Society Guideline 14. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user.

The Ceribell Infant Seizure Detection Software does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

The Ceribell Infant Seizure Detection Software is a software-only device that is intended to mark previously acquired sections of EEG recordings that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces.

Ceribell Infant Seizure Detection Software: Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 713 patients.
  • 25-36 weeks PMA: 155 patients
  • 37-44 weeks PMA: 321 patients

  • 44 weeks PMA: 237 patients

• Data Provenance: The EEG recordings were obtained from patients less than 1 year of age who received continuous EEG monitoring within the hospital environment. The study was retrospective. The country of origin is not explicitly stated in the provided text.

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

• Number of Experts: 3
• Qualifications of Experts: Expert pediatric neurologists who were fellowship-trained in epilepsy or clinical neurophysiology.

4. Adjudication Method for the Test Set

• Adjudication Method: A two-thirds majority agreement among the 3 expert pediatric neurologists was required to form a determination of seizures, establishing the reference standard for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the standalone performance of the algorithm against an expert-adjudicated ground truth.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance study was done. The performance metrics (PPA and FP/hr) were evaluated for the Ceribell Infant Seizure Detection Software algorithm without human intervention in the detection process. The reviewing neurologists for ground truth establishment were explicitly blinded to the software's output.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (adjudication by a panel of 3 expert pediatric neurologists).

8. The Sample Size for the Training Set

• The sample size for the training set is not provided in the document. The document states, "Importantly, none of the data in the validation dataset were used for training of the Seizure Detection algorithm; the validation dataset is completely independent."

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. It only mentions that the validation dataset was independent and not used for training.

Ask a specific question about this device