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510(k) Data Aggregation

    K Number
    K993381
    Device Name
    TONGUE STABILIZER DEVICE
    Manufacturer
    UNIVERSITY OF OTAGO
    Date Cleared
    1999-12-21

    (75 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K081965
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used for the treatment of simple snoring in both dentate and edentult patientis. Can be used also for the treatment of snoring in patients with periodontically comprised dentitions and likewise patients presenting with Tempero-mandibular Dysfunction (TMD). Cephalometric and videoendoscopy studies have established that tongue protrusion creates a greater, increase in oropharyIngeal, velopharyngeal and hypopharyngeal cross-sectional areas of the upper airway, hence improving airway patency and function.

    Device Description

    TONGUE STABILIZING DEVICE

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device and does not contain the detailed information about acceptance criteria, study design, or performance metrics that you are requesting. The letter primarily states that the device, a "Tongue Stabilizer Device" for the treatment of simple snoring, is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot extract the following information from the given text:

    • A table of acceptance criteria and the reported device performance
    • Sample size used for the test set and the data provenance
    • Number of experts used to establish the ground truth for the test set and their qualifications
    • Adjudication method for the test set
    • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
    • Whether a standalone (algorithm only) performance study was done
    • The type of ground truth used
    • The sample size for the training set
    • How the ground truth for the training set was established

    The document explicitly mentions "Cephalometric and videoendoscopy studies have established that tongue protrusion creates a greater, increase in oropharyngeal, velopharyngeal and hypopharyngeal cross-sectional areas of the upper airway, hence improving airway patency and function." However, details about these studies, such as their acceptance criteria, specific results, sample sizes, or ground truth methodology are not provided in this regulatory letter.

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