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510(k) Data Aggregation

    K Number
    K022284
    Device Name
    SNORE-AID MAX
    Manufacturer
    DENTAL IMAGINEERS, LLC
    Date Cleared
    2002-12-10

    (148 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K962516,K882303
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Snore-Aid® Max is prescribed for the patient by the healthcare professional.
    A. Snore-Aid® Max is indicated for use in patients with benign snoring, or snoring and mild to moderate obstructive sleep apnea (OSA) where mandibular advancement and tongue positioning can increase pharyngeal air space.
    B. Snore-Aid® Max is indicated to prevent symptoms of nocturnal parfunctional jaw activity in patients who are undergoing treatment for snoring and/or OSA by mandibular advancement and tongue positioning.

    Device Description

    The Snore-Aid® Max is a hybrid appliance that may utilize the external lip shield or it may utilize an internal lip shield. In the latter case, the lip shield must be applied against a thin vacuum formed tray to protect the gingival tissue and adsorb pressure across the maxillary arch. The value of both methods is that there is no hinge required in the appliance. Also, the design of Snore-Aid® Max facilitates a simple and inexpensive chair side process using polycaprolactone to mold and customize the body of the appliance.

    AI/ML Overview

    This document is a 510(k) summary for the Snore-Aid® Max device, an anti-snoring device. The document explicitly states "Clinical Data: See section on performance" but no such section detailing performance, acceptance criteria, or a study is included in the provided text.

    Therefore,Based on the provided text, there is no information available regarding:

    1. A table of acceptance criteria and the reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts used to establish ground truth and their qualifications.
    4. Adjudication method for the test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study and effect size.
    6. Standalone (algorithm-only) performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How the ground truth for the training set was established.

    The document primarily focuses on establishing substantial equivalence to predicate devices (Snore-Aid® Plus, Quiet Knight, and Snore Guard) based on intended use and technological characteristics, rather than presenting clinical study data regarding acceptance criteria and performance. The FDA letter confirms the substantial equivalence determination but does not refer to a detailed performance study within the provided text.

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