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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
    Predicate For
    K220090
    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<0.001).
    Mean difference between paired tests (CVA-1000 vs. ETDRS chart) < 0.1 logMAR.The mean difference remained below 0.1 logMAR, which is less than the test-retest reliability of either test.
    Test-retest reliability (sigma of test-retest acuity differences) of CVA-1000 modules similar to corresponding ETDRS chart.The sigma of the test-retest acuity differences for each CVA module was similar to those of the corresponding chart.
    No learning effect observed for CVA-1000 modules.Test-retest differences in logMAR for each CVA module were nearly zero, similar to the ETDRS chart, confirming no learning effect.

    2. Sample Size and Data Provenance

    • Test Set Sample Size: 481 eyes from 241 normal individuals (ages 18 to 65). Total of 809 comparisons analyzed (due to testing emmetropic, myopic, and hyperopic eyes with both contact lenses and spectacle correction).
    • Data Provenance: Not explicitly stated, but given the context of a 510(k) submission to the FDA, it is highly likely the study was conducted in the USA. The study was prospective as it involved clinical testing performed to demonstrate equivalence.

    3. Number of Experts and Qualifications for Ground Truth

    • The ground truth in this study was established by comparison to a recognized predicate device (ETDRS charts). Therefore, there were no external experts establishing a new ground truth. The "ground truth" was effectively the established measurements from the ETDRS charts. The CVA-1000's measurements were compared against these established values.

    4. Adjudication Method

    • None in the traditional sense for conflict resolution. The study design involved directly comparing measurements from the CVA-1000 to the predicate ETDRS charts. The "adjudication" was statistical comparison, not expert consensus on discrepancies.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the equivalence of the device's measurements to a predicate device, not on how human readers' performance might improve with or without AI assistance. The CVA-1000 is a standalone measurement tool, not an AI assistance system for human readers.

    6. Standalone Performance

    • Yes, a standalone performance study was done. The study specifically compared the CVA-1000's direct measurements of visual acuity to the measurements obtained using the predicate ETDRS charts. The device's performance was evaluated independently.

    7. Type of Ground Truth Used

    • Predicate Device Measurements: The ground truth was established by the measurements obtained from the predicate ETDRS charts. These charts are a recognized standard for visual acuity assessment.

    8. Sample Size for the Training Set

    • The document does not mention a training set for the CVA-1000. This suggests that the device, or at least the specific functionalities tested, may not utilize machine learning models that require a distinct training phase. It appears to be a direct measurement system.

    9. How Ground Truth for Training Set Was Established

    • As no training set is mentioned or implied, this information is not applicable.
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