Search Results

Cadwell Spike and Seizure Detector is a software-only product with an algorithm intended to analyze and mark events that may correspond to epileptiform discharge (spike) and electrographic seizure for the purpose of reviewing scalp EEG recordings. The marked events are reviewed, deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information.

This device does not control the delivery of energy, administration of drugs, or another form of life sustaining function to the patient. It is intended for use in patients who are 18 years or over.

This device does not provide any diagnostic conclusion about the patient to the user.

Cadwell Spike and Seizure Detector is a software-only product with an algorithm intended to analyze and mark events that correspond to spikes and seizures for the purpose of reviewing EEG recording. This application is for use by trained users such as neurologists, clinicians, registered EEG technicians. It requires EEG data recorded with a standard montage using the 10/20 electrode placement. The detected events are annotated on the EEG record for review by a trained user.

Here's a breakdown of the acceptance criteria and study details for the Cadwell Spike and Seizure Detector, based on the provided 510k summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The validation results show that the Cadwell Spike and Seizure Detector meets the objective for device effectiveness and substantial equivalence." but does not provide specific numerical thresholds for "Pass" for positive percent agreement or negative disagreement rate for either spike or seizure detection. The figures (Figures 1, 2, 3, and 4) graphically compare the device's performance to individual experts and the predicate device (Persyst Reveal) without explicit numerically stated acceptance criteria for each metric.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 76 records from unique patients.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the US FDA, implying U.S. or internationally applicable standards.
  • Retrospective or Prospective: Retrospective, as records were "selected from unique patients" and "acquired in an epilepsy monitoring unit as part of routine clinical protocol."

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Three human experts.
• Qualifications: "Three human experts reviewed the complete raw EEG for each record and marked spike and seizure events." Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed beyond "human experts." It can be inferred they are neurologists or highly experienced EEG technicians given the context of epilepsy monitoring units and EEG review.

4. Adjudication Method for the Test Set

• Adjudication Method: Majority rule (agreement between any two of three experts) using "any overlap method" was applied to construct the reference set.

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

• MRMC Study: Not explicitly stated as a formal MRMC comparative effectiveness study (e.g., comparing human readers with and without AI assistance). However, the study did compare the device's performance against individual human experts and a predicate device (Persyst Reveal) for both spike and seizure detection.
• Effect Size of Human Readers Improve with AI vs. without AI Assistance: This specific metric was not reported. The study focused on the standalone performance of the device compared to experts and the predicate.

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

• Standalone Performance: Yes, a standalone performance evaluation was conducted. The study assessed "Cadwell Spike Detector" and "Cadwell Seizure Detector" against the ground truth established by experts, as shown in Figures 1-4. The device analyzes and marks events "for the purpose of reviewing EEG recording" by trained users, implying a standalone analytical component that then feeds into human review.

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus. Specifically, "Majority rule (agreement between any two of three experts)" was used to establish the reference set for both spike and seizure events.

8. The Sample Size for the Training Set

• Training Set Size: The document does not specify the sample size for the training set. The descriptions given relate to the validation/test set.

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

• Training Set Ground Truth: This information is not provided in the 510k summary. The summary focuses solely on the validation/test methodology.

Ask a specific question about this device