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510(k) Data Aggregation

    K Number
    K973544
    Device Name
    VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER
    Manufacturer
    VACUMED, DIV. OF VACUMETRICS, INC.
    Date Cleared
    1998-05-26

    (250 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K922660
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended for measuring the concentration of carrbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status.

    Device Description

    Not Found

    AI/ML Overview

    This response is based on the provided text, which is an SMDA Summary of Safety and Effectiveness Information for the Vacu•Med, Gold Edition, Carbon Dioxide Gas Analyzer (K973544).

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Accuracy of measurement of expired CO2 gases equivalent to the predicate device.Calibration accuracy of the Vacumetrics Gold Edition Carbon Dioxide Gas Analyzer is equivalent to the accuracy of the PHYSIO-DYNE Easi-Lab Gas Analyzer. The device functions with an accuracy of 0.1% CO2.

    2. Sample Size for the Test Set and Data Provenance

    The document does not specify the sample size used for the comparative performance test. It only mentions "conditions of the test" and "the data." The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective).

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    The document does not mention the use of experts to establish a "ground truth" for the test set. The study focuses on comparing the new device's calibration accuracy against a predicate device.

    4. Adjudication Method for the Test Set

    No adjudication method is mentioned as a specific "ground truth" was not established by multiple experts. The comparative test likely relied on a direct comparison of measurements between the two devices.

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

    No, an MRMC comparative effectiveness study was not done. The study was a direct comparison of a single device (the Vacu•Med Gold Edition) against a predicate device (PHYSIO-DYNE Easi-Lab Gas Analyzer) for calibration verification. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

    6. Standalone (Algorithm Only) Performance

    Yes, a standalone performance assessment was conducted in the sense that the device's accuracy was tested directly against a predicate device for its intended function (measuring CO2 gases). This isn't an "algorithm only" in the modern AI sense, but rather a direct measurement of the device's functional output. The performance (accuracy of 0.1% CO2 and equivalence to the predicate) is reported for the device itself.

    7. Type of Ground Truth Used

    The "ground truth" for this study was the performance of a legally marketed predicate device (PHYSIO-DYNE Easi-Lab, K922660). The goal was to demonstrate substantial equivalence, meaning the new device performed as accurately as the established device.

    8. Sample Size for the Training Set

    No training set is mentioned. This device is a gas analyzer, and the study did not involve machine learning or AI that would typically require a training set. The evaluation was based on a direct comparative performance test.

    9. How the Ground Truth for the Training Set was Established

    Not applicable, as there was no training set.

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