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510(k) Data Aggregation

    K Number
    K091880
    Device Name
    CLAYTON INTRA-AURAL DEVICE (CID)
    Manufacturer
    ASCENTIA HEALTH INCORPORATED
    Date Cleared
    2010-02-24

    (245 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K981546
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CID is indicated as an aid in reducing temporomandibular disorder (TMD) pain.

    Device Description

    The CID is comprised of a pair of small, hollow, ear inserts made of medical grade polymers that is custom-fit to each subject's ear canals. It is constructed from methacrylate polymers and similar rigid plastics that have been safely used in commercially available hearing aids for decades. The CID is designed to rest in the outer third of the ear canal and has a small retraction post that allows for ease of removal of the device from the ear canal. It is designed to conform to the shape of the ear canal when the jaw is in a slightly open position.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

    K091880: Clayton Intra-aural Device (CID) - Acceptance Criteria and Study Details

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for device performance. Instead, it demonstrates the CID's non-inferiority to a predicate device (stabilization splint) and statistically significant reductions in pain and dysfunction. Therefore, the "acceptance criteria" are inferred from the study's primary and secondary efficacy objectives, which are to show non-inferiority for CMI reduction and significant pain reduction.

    Performance Metric / Acceptance Criteria (Inferred)Reported Device Performance (CID)Comparison to Predicate (Stabilization Splint)
    Primary Efficacy Objective: Non-inferiority to stabilization splint in reduction of Craniomandibular Index (CMI) scores from baseline to 3 months.Demonstrated statistically significant non-inferiority to the stabilization splint (p=0.0096).
    Average percentage change in CMI scores from baseline to 3 months: 45% reduction.Average percentage change in CMI scores from baseline to 3 months: 41% reduction.
    Differences between study groups did not rise to the level of statistical significance, but CID showed higher percentage reduction.
    Secondary Efficacy Objective: Statistically significant reductions from baseline in TMD pain (VAS scores).In-office VAS scores showed statistically significant reductions:
    • 1 month: **46% reduction (p
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