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510(k) Data Aggregation

    K Number
    K110205
    Device Name
    AAIO-7, AAIO WIRLESS
    Manufacturer
    APPASAMY ASSOCIATES
    Date Cleared
    2011-02-09

    (15 days)

    Product Code
    HLI
    Regulation Number
    886.1570
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AAIO-7 & AAIO Wireless, is a head mounted Binocular Indirect ophthalmoscope designed to be Used by trained personnel for illuminating and viewing parts of the eye such as the Cornea and retina when used in conjunction with an ophthalmic lens.

    Binocular Indirect Ophthalmoscope provides an illumination system to direct appropriately, focused light into the eye in order to obtain an intermediate image of the fundus (retina) that is viewed by the observer to diagnose the eye.

    Device Description

    Binocular Indirect ophthalmoscope: AAIO-7 AAIO WIRELESS

    AI/ML Overview

    I am sorry, but the provided documentation does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets them. The text primarily consists of an FDA clearance letter for a device and its indications for use. There is no mention of:

    • Acceptance criteria tables or reported device performance
    • Details of a study, including sample sizes, data provenance, ground truth establishment, or expert qualifications
    • Adjudication methods
    • MRMC studies or effect sizes
    • Standalone algorithm performance
    • Training set details

    Therefore, I cannot fulfill your request based on the given input.

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