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510(k) Data Aggregation

    K Number
    K092039
    Device Name
    IDENTEVENT, VERSION 1.0G
    Manufacturer
    OPTIMA NEUROSCIENCE, INC.
    Date Cleared
    2009-10-16

    (102 days)

    Product Code
    OMB,OLT
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K011397,K041263
    Why did this record match?
    Device Name :

    IDENTEVENT, VERSION 1.0G

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IdentEvent ™ is a software-only product with an algorithm intended to analyze previously acquired, adult (≥18 years) scalp EEG signals and mark events that may correspond to electrographic seizures for the purpose of reviewing prolonged EEG traces. The marked events are reviewed, possibly deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information.

    IdentEvent also includes the display of the quantitative EEG parameters Amplitude Variation and Maximum Frequency, which are intended to help the user analyze the EEG waveform after it has been collected.

    IdentEvent requires the use of EEGs recorded with at least a 16-channel scalp montage following the standard 10/20 electrode placement system. IdentEvent does not provide any diagnostic conclusion about the patient's condition to the user.

    Device Description

    Optima's IdentEvent™ analyzes digital scalp electroencephalograph (EEG) signals recorded from standard recording systems and displays information about brain electrical activity to the user. The application only analyzes and displays information from previously recorded digital EEG files. IdentEvent is designed for post-hoc EEG review of long-term EEG recordings, including the detection of seizure events.

    IdentEvent requires previously recorded, digitized scalp EEG recordings with electrodes placed according to the standard 10/20 system. The recording can then be automatically analyzed to detect seizures which are then marked for review by the user. IdentEvent includes the following features (outputs):

    • Display of raw & filtered EEG signals for review
    • Display of the following quantitative EEG (qEEG) measures:
      • Amplitude Variation
      • Maximum Frequency
    • Review (and possible deletion) of detected seizures
    • Entry, editing and display of user-entered comments
    • Graphical and text reports of detected seizures and comments.
    AI/ML Overview

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

    Acceptance Criteria and Device Performance

    Acceptance Criteria (Target performance vs. Predicate Device)Reported Device Performance (IdentEvent)Predicate Device Performance (Persyst Reveal) Comparison
    Positive Percent Agreement (Detection Sensitivity)79.5% (95% CI: 70%, 87%)Similar to Predicate (Reveal (0.5): 80.8% (95% CI: 72%, 88%))
    Negative Disagreement Rate (False Detection Rate)2/24h (95% CI: 1.3, 3.3)/24hSignificantly better than Predicate. Reveal (0.5): 13/24h, Reveal (0.8): 8/24h, Reveal (0.9): 6/24h
    Substantial Equivalence in SafetyMet (based on validation testing of software requirements, including patient information handling, data integrity, and abnormality notification)N/A (compared to predicate)

    Study Details

    1. Sample Size and Data Provenance:

      • Test Set Sample Size: A total of 436 EEG segments sampled from 55 long-term scalp EEG recordings. These 55 recordings came from 55 patients.
      • Data Provenance: Retrospective. The patients had medically refractory seizures and were admitted to multiple clinical sites for long-term EEG-video recordings for diagnostic or pre-surgical evaluation. The location of these clinical sites (country of origin) is not explicitly stated.

    2. Number and Qualifications of Experts for Ground Truth:

      • Number of Experts: Three independent, blinded EEG experts.
      • Qualifications: All were neurologists/epileptologists. Specific years of experience are not mentioned.

    3. Adjudication Method for Test Set:

      • A majority rule (at least 2 out of 3) was applied to determine the "true" electrographic seizure events. This method was chosen due to anticipated inter-rater variability among EEG experts.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

      • No, a MRMC study was not explicitly described in the provided text. The study focused on comparing the algorithm's performance (IdentEvent) against a predicate device's algorithm (Persyst Reveal) and against expert consensus, not on evaluating human reader improvement with or without AI assistance.

    5. Standalone (Algorithm Only) Performance Study:

      • Yes, a standalone study was performed. The "IdentEvent" algorithm's performance was evaluated independently against the reference standard established by the expert panel. The reported "Positive % Agreement" and "Negative Disagreement Rate" are standalone performance metrics for the algorithm.

    6. Type of Ground Truth Used:

      • Expert Consensus: The ground truth for electrographic seizures was established by a panel of three independent, blinded neurologists/epileptologists using a majority rule.

    7. Training Set Sample Size:

      • The document does not explicitly state the sample size for the training set. It only describes the test dataset.

    8. How Ground Truth for Training Set Was Established:

      • The document does not describe how the ground truth for any potential training set was established. It only details the establishment of ground truth for the test set used for performance evaluation.
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