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510(k) Data Aggregation

    K Number
    K082849
    Device Name
    SILENT SLEEP
    Manufacturer
    CRANIOFACIAL PAIN CENTER OF IDAHO
    Date Cleared
    2009-07-16

    (290 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. For the temporary or trial treatment of snoring and mild to moderate obstructive sleep apnea in adults over age 18. The Silent Sleep is not intended to be used for more than 30 days.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an intraoral device called "Silent Sleep." It discusses the regulatory classification and general controls applicable to the device.

    However, this document does not contain any information about acceptance criteria for device performance, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment methods.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from this document.

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