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510(k) Data Aggregation

    K Number
    K083387
    Device Name
    MODIFICATION TO KOWA NONMYD ALPHA-DIII
    Manufacturer
    KOWA CO. LTD.
    Date Cleared
    2009-01-16

    (60 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Type
    Special
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K082767
    Why did this record match?
    Reference Devices :

    K082767

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

    KOWA nonmyd ct-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retimal image can be stored to an image filing drive through serial ınterface

    Device Description

    KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic The retinal image can be stored to an image filing drive through serial ınterface

    AI/ML Overview

    The provided text does not contain acceptance criteria or a study proving that the device meets acceptance criteria.

    The document is a 510(k) premarket notification for the KOWA nonmyd α-DIII (Type 2), a fundus camera. Its primary purpose is to demonstrate substantial equivalence to a predicate device (KOWA nonmyd α-DIII (Type 1), K082767), rather than to present a performance study with defined acceptance criteria.

    The information provided describes:

    • Device Name: KOWA nonmyd α-DIII (Type 2)
    • Intended Use: Retinal image capturing without mydriatic, with image storage capabilities.
    • Comparison: The new device is compared to a predicate device (KOWA nonmyd α-DIII (Type 1)).
    • Modifications: The modifications made to the new device are listed as:
      • Change in power supply.
      • Change in CCD camera to one with the same resolution (8.3M pixels) and sensitivity from another manufacturer.
      • Addition of montage function in associated software.
      • Addition of advanced search function in associated software.
    • Conclusion: The FDA determined substantial equivalence, meaning the new device has the same fundamental technology and safety performance as the predicate device.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth, as this information is not present in the provided text.

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