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    K Number
    K961247
    Device Name
    AS/3 LIGHT MONITOR
    Manufacturer
    DATEX DIVISION INSTRUMENTARIUM CORP.
    Date Cleared
    1996-10-23

    (205 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AS/3 LIGHT MONITOR

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

    AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient's vital signs.

    Device Description

    AS/3 Light Monitor is a portable patient monitor which measures ECG, 2 invasive blood pressures, oxygen saturation SpO2, 2 temperatures and non-invasive blood pressure NIBP. The measurement technics are similar to the AS/3 Compact Monitor with ESTP module and NIBP module. AS/3 Light Monitor will be available in two following configurations: LM which measures ECG, SpO2, 1 temperature and NIBP and LMP which measures ECG, SpO2, 2 invasive blood pressures, 2 temperatures and NIBP. The monitor can be driven with battery or with mains power.

    AI/ML Overview

    The provided text is a 510(k) summary for the Datex AS/3 Light Monitor, a patient vital signs monitor. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Datex AS/3 Compact Monitor with ESTP and NIBP modules).

    However, the document does not contain information related to acceptance criteria, detailed study results proving device performance against acceptance criteria, or specifics about a study design involving experts, ground truth, or statistical analysis (like MRMC studies) typically associated with AI/ML device evaluations.

    This 510(k) summary is for a traditional medical device (a vital signs monitor), not an AI/ML powered device. Therefore, the requested information elements, particularly those related to "AI improvement," "ground truth," "training set," and "expert consensus/adjudication," are not applicable and are not present in the provided text.

    The document states that "The specifications of the monitors were compared and AS/3TM Light Monitor was tested against the specifications." This indicates that performance was evaluated against a set of predefined specifications, but the specifics of these specifications and the detailed test results are not included in this summary. The summary only concludes that the results "showed that AS/3TM Light Monitor is substantially equivalent with AS/3TM Compact Monitor."

    If this were an AI/ML device submission, the requested information would be crucial. As it stands, the provided text does not allow for a complete answer to your detailed questions.

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