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510(k) Data Aggregation

    K Number
    K161328
    Device Name
    Cantab Mobile
    Manufacturer
    CAMBRIDGE COGNITION LTD., US AGENT: CLEMENTI ASSOCIATES LTD.
    Date Cleared
    2017-01-13

    (246 days)

    Product Code
    PKQ
    Regulation Number
    882.1470
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Cantab Mobile

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

    The CANTAB Mobile is intended to be used as an adjunctive tool to assess memory by testing visuospatial associative learning in patients aged 50 to 90 years.

    Device Description

    Not Found

    AI/ML Overview

    This is a premarket notification for the Cantab Mobile device, a computerized cognitive assessment aid. The provided text, however, focuses on the regulatory correspondence from the FDA and the device's indications for use. It does not contain the detailed technical information about acceptance criteria or the study used to prove the device meets them.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based only on the provided text.

    To answer your questions, I would need access to the actual 510(k) submission summary or a separate performance study report for the Cantab Mobile device.

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