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510(k) Data Aggregation

    K Number
    K202588
    Device Name
    BNA Platform
    Manufacturer
    elminda, Ltd
    Date Cleared
    2020-12-07

    (90 days)

    Product Code
    OLU
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K121119,K171414
    Why did this record match?
    Applicant Name (Manufacturer) :

    elminda, Ltd

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

    The BNA™ Platform is to be used by qualified medical professionals for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), including event-related potentials ("ERPs').

    This device is indicated for use in individuals 12 to 85 years of age.

    The BNA™ Platform is to be used with the Auditory Oddball, Visual Go No-Go (age range of 25 to 85 years), and Eyes-Closed tasks.

    Device Description

    The BNATM Platform is intended for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing both resting-state EEG and Event-Related Potentials ("ERP") in a patient's response to outside stimuli during various states of alertness, disease, diagnostic testing, treatment, surgery, or drug related dysfunction. An Event-Related Potential (or "evoked response") is an electrical potential recorded from the nervous system following the presentation of a stimulus (e.g., as part of a cognitive task). An ERP signal consists of typical ERP components - positive or negative voltage spatiotemporal peaks within the ERP waveform that are measured within one second post-stimulus presentation. The BNATM Platform is intended to analyze EEG data recorded at rest and during the performance of two conventionally used ERP tasks, the Auditory Oddball (AOB) and the Visual Go No-Go (VGNG).

    The EEG is recorded continuously while the patient is at rest with eyes-closed (hereby Eyes-Closed) or performs one of the ERP tasks (hereby ERP tasks). The acquisition site is asked to provide reliable samples of artifact-free digital EEG for purposes of analysis. After the recording, the artifact-free EEG data is imported into the BNATM Platform and is automatically analyzed by the algorithm and the results of the processed data are compiled into individualized Reports:

    • . ERP Report
    • Behavioral Report ●
    • . Summary Report
    • Resting-State EEG Report ●

    Scores are presented as Z-Scores based on comparing the patient to an age-matched relevant reference group based on elminda's normative database. This presentation expresses the differences between the patient and the reference group.

    The BNA™ Reports are intended to be used by clinicians to enable the evaluation of the patient's brain activity during a specific task compared to an age-range matched reference group.

    The system consists of the following components: a computer environment; EEG data input software algorithms for BNA™ calculations; a report generator and a functionality for data transfer and storage.

    The device processes and analyzes data received from a dedicated, commercially available, and FDA cleared EEG system, which complies with the BNATM Platform specifications.

    AI/ML Overview

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

    Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Success Rate)Reported Device PerformanceDiscussion
    Normality of EEG ScoresPass at least 2 of 4 normality tests (p-value > 0.05)All Resting-EEG and ERP scores pass "two out of four" method tests with a success rate > 97% for Resting-EEG and > 98% for ERP.The study aimed to demonstrate that the expanded age ranges and tasks maintain the statistical properties of the original predicate device. A success rate above 97% and 98% for ERP scores indicates high compliance with the normal distribution assumption, allowing for reliable Z-score interpretation. This is explicitly stated to be "in accordance with the success rates presented in the predicate device statistical performance and, from a clinical perspective, allow for an accurate clinical interpretation of z-scores."
    Gaussian Leave-One-Out Sensitivity Test (for Resting-EEG)Success rate > 97.5%Resting-EEG scores pass with a success rate > 97.5%.This additional test for Resting-EEG further validates the robustness of the normality assumption, with the reported success rate meeting the criterion. The document notes this is an "acceptable percentage of failures, given the large number of scores tested."
    Poolability of Reference Group DataSignificant age-effect (p
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