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    K Number
    K122932
    Device Name
    SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
    Manufacturer
    FOGLESS INTERNATIONAL AB
    Date Cleared
    2013-12-23

    (455 days)

    Product Code
    JOH
    Regulation Number
    868.5800
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOGLESS INTERNATIONAL AB

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

    One way Speaking Valve for spontaneous breathing tracheostomy patients. The device connects directly to an ISO 15mm tracheostomy tube. The valve opens upon inhalation and then closes immediation, forcing the expired gasses through the larynx and mouth to produce speech.

    Device Description

    One way Speaking Valve

    AI/ML Overview

    I am sorry, but based on the provided text, the document is a 510(k) premarket notification letter from the FDA regarding a device named "SPIRO Speaking Valve." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone) related to AI or even general device performance data beyond its indication for use.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided input.

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