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510(k) Data Aggregation

    K Number
    K111009
    Device Name
    ACRYLIC HERBST APPLIANCE
    Manufacturer
    EMBASSY DENTAL LABORATORY
    Date Cleared
    2011-07-22

    (102 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K070327,K083209,K103076
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMBASSY DENTAL LABORATORY

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

    The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

    Device Description

    The Acrylic Herbst Appliance is comprised of custom-fabricated acrylic splints (methylmethacrylate) which are connected bilaterally via a telescoping Herbst mechanism (stainless steel).

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary and FDA clearance letter for the Acrylic Herbst Appliance, which establishes substantial equivalence to existing predicate devices.

    Therefore, I cannot fulfill the request to provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts and their qualifications for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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