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510(k) Data Aggregation

    K Number
    K961937
    Device Name
    SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM
    Manufacturer
    DELPHI CONSULTING GROUP
    Date Cleared
    1996-12-09

    (203 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM

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

    The SimulScope® Bedside Auscultation System allows the user to amplify heart, lung and bowel sounds and transmit them via infrared energy to wireless headphone worn by more then one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener.

    Device Description

    The SimulScope® Bedside Auscultation System allows the user to amplify heart, lung and bowel sounds and transmit them via infrared energy to wireless headphone worn by more then one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener.

    AI/ML Overview

    The provided text is a 510(k) summary for the SimulScope® Bedside Auscultation System. It focuses on demonstrating substantial equivalence to predicate devices based on product features and intended use. The document does not describe acceptance criteria, the results of a study to meet those criteria, or any of the detailed study information requested in your prompt.

    Specifically, the document omits information such as:

    • Acceptance Criteria Table: No such table is present.
    • Sample Size and Data Provenance for Test Set: No test set is mentioned.
    • Number of Experts for Ground Truth: No ground truth experts are mentioned.
    • Adjudication Method: No adjudication method is mentioned.
    • MRMC Comparative Effectiveness Study: No MRMC study is mentioned.
    • Standalone Performance Study: No standalone performance study is mentioned.
    • Type of Ground Truth: No ground truth beyond general performance characteristics (acoustic/electronic operation, frequency range, etc.) is mentioned.
    • Training Set Sample Size: No training set is mentioned.
    • Ground Truth for Training Set: No information is provided.

    The document's primary purpose is to compare the new device's features and principles of operation to existing, legally marketed devices to establish substantial equivalence, rather than to present data from a performance study demonstrating specific acceptance criteria.

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