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510(k) Data Aggregation

    K Number
    K963672
    Device Name
    MODEL 90022 ROLLING STAND
    Manufacturer
    AUGUSTINE MEDICAL, INC.
    Date Cleared
    1997-01-06

    (115 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODEL 90022 ROLLING STAND

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

    Not Found

    Device Description

    The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System®-Modification.

    AI/ML Overview

    This looks like a 510(k) summary for a medical device (a rolling stand for a patient warming system), not an AI/ML powered device. The questions you've asked (acceptance criteria, study details, ground truth, MRMC studies, etc.) are highly relevant to the evaluation of AI/ML diagnostic devices, but they don't apply to a physical device like a rolling stand.

    Therefore, I cannot provide the requested information because the provided text describes a physical medical device (a rolling stand) and not an AI/ML powered diagnostic device that would have a "reported device performance" against specific "acceptance criteria" through a "study" involving "ground truth," "experts," or "training sets."

    The document focuses on the safety and effectiveness of the rolling stand in terms of physical stability and proper usage with its intended warming unit, not on diagnostic accuracy based on an algorithm.

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