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510(k) Data Aggregation

    K Number
    K974747
    Device Name
    CS/3 ARRHYTHMIA WORKSTATION
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-04-23

    (125 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CS/3 ARRHYTHMIA WORKSTATION

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

    The CS/3™ Arrythmia Workstation (ARRWS) is indicated for centralized monitoring, arrhythmia analysis and detection, waveform data storage and patient data storage in hospitalized patients connected to Datex-Engstrom monitors.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a 510(k) clearance letter from the FDA regarding the "CS/3™ Arrhythmia Workstation." This document confirms the device's substantial equivalence to a predicate device and outlines regulatory information.

    However, this document does not contain any information about:

    • Acceptance criteria
    • Reported device performance
    • Details of a study proving the device meets acceptance criteria
    • Sample sizes (test or training set)
    • Data provenance
    • Number or qualifications of experts for ground truth
    • Adjudication methods
    • MRMC comparative effectiveness study
    • Standalone algorithm performance
    • Type of ground truth used
    • How ground truth for training was established

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely a regulatory clearance communication, not a performance study report.

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