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    K Number
    K970887
    Device Name
    BLOOD FLOW ANALYZER
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    1997-06-17

    (98 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K873422
    Predicate For
    K023245
    Why did this record match?
    Reference Devices :

    K873422

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

    A tonometer and acsessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.

    Device Description

    A tonometer and accessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.

    AI/ML Overview

    The Blood Flow Analyzer, manufactured by Paradigm Medical Industries, Inc., is a tonometer and accessories intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). This device is intended for use in the diagnosis of glaucoma.

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Degree of Accuracy (< 3mmHg)< 3mmHg when compared with Goldmann tonometry

    2. Sample Size and Data Provenance

    The provided document does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

    3. Number of Experts and their Qualifications

    The provided document does not contain information regarding the number of experts used to establish the ground truth for the test set or their qualifications.

    4. Adjudication Method

    The provided document does not contain information regarding the adjudication method used for the test set.

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

    There is no indication in the provided document that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, or any effect size related to human reader improvement with AI assistance. The device described appears to be a standalone instrument for physical measurement, not an AI-assisted diagnostic tool for image interpretation by readers.

    6. Standalone Performance

    The document describes the "Degree of Accuracy" of the Blood Flow Analyzer as "<3mmHg when compared with Goldmann tonometry." This indicates a standalone performance evaluation of the device's accuracy in measuring intraocular pressure.

    7. Type of Ground Truth Used

    The ground truth used for establishing the accuracy of the Blood Flow Analyzer was Goldmann tonometry. The device's accuracy is reported as being "<3mmHg" in comparison to this established method.

    8. Sample Size for the Training Set

    The provided document does not contain information regarding the sample size for the training set.

    9. How Ground Truth for Training Set was Established

    The provided document does not contain information regarding how the ground truth for the training set was established.

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