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510(k) Data Aggregation

    K Number
    K131506
    Device Name
    AIRWAY SUPPORT SYSTEM / AIRPORT
    Manufacturer
    ABEON MEDICAL CORPORATION
    Date Cleared
    2014-03-06

    (286 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K142467
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AirPort is indicated for use in patients requiring supplemental oxygenation, patients requiring, and patients requiring non-definitive airway support. To be used in one or any combination of the preceding circumstances.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information required to answer the request about acceptance criteria and study details. The document is an FDA 510(k) clearance letter for the "AirPort" device, which is a Carbon Dioxide Gas Analyzer. It states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use.

    However, it does not include:

    1. A table of acceptance criteria or reported device performance.
    2. Details on sample sizes for test or training sets, nor data provenance.
    3. Information on the number or qualifications of experts, or adjudication methods.
    4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
    5. Whether a standalone algorithm-only performance study was done.
    6. The type of ground truth used.
    7. How the ground truth for any training set was established.

    Therefore, I cannot extract the requested information from this document.

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