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510(k) Data Aggregation

    K Number
    K100095
    Device Name
    CENTRAL VISION ANALYZER MODEL 1000
    Manufacturer
    VIMETRICS,LLC.
    Date Cleared
    2010-05-10

    (117 days)

    Product Code
    HOX
    Regulation Number
    886.1150
    Type
    Abbreviated
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K913337
    Why did this record match?
    Product Code :

    HOX

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

    The CVA-1000 is intended for use under the direct supervision of an ophthalmologist or optometrist in the measurement of vision at fixation in one or both eyes, with or without optical correction.

    Device Description

    The CVA-1000 instrument is a standalone device consisting of a computer processing unit with data storage, two LCD monitors, a physician viewed monitor and a patient viewed monitor, and connected keyboard and mouse for physician interaction with a response pad for patient interaction. The instrument provides an evaluation of vision at fixation of one or both eyes under different conditions of contrast and lighting assisting the ophthalmologist or optometrist in evaluating the effects of prescribed refractive instruments such as spectacles or contact lenses and of pharmaceutical treatment or surgical procedures on the central vision of one or both eyes.

    The instrument may be used in either of two methods of operation: Chart Panel or Interactive Central Vision Panel.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Vimetrics Central Vision Analyzer 1000 (CVA-1000), based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Pearson correlation coefficient between CVA-1000 modules and corresponding logMAR chart > 0.8.All but one CVA module (98% black Landolt C's against a bright white background) had a Pearson correlation coefficient > 0.8. The excepted module still showed a correlation > 0.5. All correlations were statistically significant (p
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