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510(k) Data Aggregation

    K Number
    K150498
    Device Name
    Discovery 24
    Manufacturer
    BRAINMASTER TECHNOLOGIES, INC.
    Date Cleared
    2016-01-26

    (334 days)

    Product Code
    GWQ,GWO
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    k941551
    Why did this record match?
    Device Name :

    Discovery 24

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

    Indicated for prescription use to acquire, record, transmit, and data for electroencephalograph studies of patients of all ages.

    Device Description

    The BrainMaster™ Discovery 24 are two-channel, four- channel, and 24-channel electrophysiological acquisition and biofeedback devices. The 24-channel (Discovery 24) digital EEG devices use industry-accepted Windowsbased PC as the control and display console. The devices consist of the following: BrainMaster™ Discovery 24 Hardware Module, BrainMaster™ software - BrainMaster™ BrainAvatar Acquisition software, Electrocap, which is sold separately. The system also includes a full set of DIN-compliant touch-proof sockets, either on the main housing, or in an accessory cable, that allows the use of "free sensors" without a cap. These products are designed for use with a standard IBM PC/AT compatible computers (Windows 7 and later) and associated peripheral equipment such as keyboard, mouse, and monitor(s). When assembled with a computer, the BrainMaster™ Discovery 24 system will acquire EEG and display and save it to disc.

    AI/ML Overview

    The provided text is a 510(k) summary for the BrainMaster Discovery 24, an electroencephalograph. It details the device's technical specifications and compares it to a predicate device, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria from an AI performance perspective.

    The document primarily focuses on:

    • Regulatory clearance: Demonstrating substantial equivalence to a predicate device (Cleveland Clinic Vanguard System).
    • Device description: Outlining the hardware and software components of the Discovery 24.
    • Technical comparison: A table comparing specifications between the Discovery 24 and the predicate device.
    • Non-clinical testing: Adherence to IEC standards for electrical medical equipment and software validation.
    • Absence of clinical tests: Explicitly stating "Not applicable."

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria as if it were an AI performance study. The device described is a medical instrument for acquiring EEG data, not an AI-driven diagnostic or analytical tool with performance metrics like accuracy, sensitivity, or specificity against established ground truth.

    If you are looking for information regarding acceptance criteria related to the technical performance of the EEG device itself (e.g., signal quality, noise levels, sampling rates), these are implicitly covered by the "Non-Clinical Tests Performed" section which references IEC standards and software validation. However, these are not "acceptance criteria" in the context of an AI study measuring diagnostic performance.

    In summary, the provided document does not contain the information requested in your bullet points because it is a regulatory submission for a data acquisition device, not a performance study for an AI algorithm.

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