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510(k) Data Aggregation

    K Number
    K971156
    Device Name
    KASHA VISUAL FIELD SYSTEM
    Manufacturer
    KASHA SOFTWARE, INC.
    Date Cleared
    1997-05-28

    (61 days)

    Product Code
    HPT
    Regulation Number
    886.1605
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    KASHA SOFTWARE, INC.

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

    The Kasha Visual Field System should be used to test the visual field of the human eye.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter for the "Kasha Visual Field System" from the FDA, dated May 28, 1997.

    This letter primarily states that the device has been found substantially equivalent to a predicate device and can, therefore, be marketed. It does not include:

    1. A table of acceptance criteria or reported device performance.
    2. Details about sample sizes, data provenance, or study design.
    3. Information on expert ground truth establishment, adjudication methods, or MRMC studies.
    4. Details about standalone algorithm performance.
    5. The type of ground truth used.
    6. Sample size or ground truth establishment for the training set.

    The document focuses on the regulatory clearance based on substantial equivalence, rather than providing the performance study details for the device.

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