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510(k) Data Aggregation

    K Number
    K123094
    Device Name
    ORTHODONTIC CERAMIC BRACKETS
    Manufacturer
    TOMY, INC.
    Date Cleared
    2012-12-13

    (72 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K060837,K082974
    Predicate For
    K160615
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Orthodontic Ceramic Brackets are indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

    Device Description

    The ORTHODONTIC CERAMIC BRACKETS are designed to move teeth to improve their alignment.

    The ORTHODONTIC CERAMIC BRACKETS are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

    No accessories are marketed with the ORTHODONTIC CERAMIC BRACKETS. The dental clinician is free to choose the bonding cement, supplemental ligatures and orthodontic wires for use with the brackets.

    AI/ML Overview

    The provided text describes an orthodontic ceramic bracket device seeking 510(k) clearance, not a medical device involving AI or complex software. As such, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable to the information provided in this 510(k) summary.

    The regulatory submission for the "Orthodontic Ceramic Brackets" focuses on demonstrating substantial equivalence to predicate devices through bench testing of physical properties, rather than clinical efficacy studies often associated with advanced diagnostic or AI-powered devices.

    Here's an analysis based only on the provided text, indicating where information is not applicable (N/A):

    1. Table of Acceptance Criteria and Reported Device Performance

    The 510(k) summary does not explicitly state quantitative "acceptance criteria" for the bench tests in the format of a target value or range. Instead, it states that "performance was achieved and validated." It implies that the newly proposed device's performance in these tests was comparable to that expected of orthodontic ceramic brackets and sufficient to demonstrate substantial equivalence to the predicate devices.

    Test TypeAcceptance Criteria (Not Explicitly Stated)Reported Device Performance
    Friction TestsPerformance achieved and validatedPerformance achieved and validated
    Flexural StrengthPerformance achieved and validatedPerformance achieved and validated
    TranslucencyPerformance achieved and validatedPerformance achieved and validated
    Shear Bond TestsPerformance achieved and validatedPerformance achieved and validated

    2. Sample Size Used for the Test Set and Data Provenance

    This information is not provided in the 510(k) summary. The submission mentions "bench testing," implying lab-based evaluation, but does not detail the number of samples used for each test or the origin of any materials beyond the statement that the device is "composed of a polycrystalline alumina ceramic bracket." The testing is prospective for the new device as it's part of its pre-market submission.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

    N/A. This device is an orthodontic bracket, and its performance evaluation through bench testing does not involve "ground truth" established by human experts in the manner of diagnostic AI. Its performance is assessed through physical property measurements.

    4. Adjudication Method for the Test Set

    N/A. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters, especially for subjective assessments. Bench testing of physical device properties does not involve such methods.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Assistance

    N/A. This is not an AI-powered device, nor does it involve human readers interpreting data. Therefore, an MRMC study and AI assistance effect size are not relevant.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    N/A. This is a physical medical device (orthodontic bracket), not an algorithm or software. Therefore, standalone algorithm performance is not applicable.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's performance is established by objective physical measurements (friction, flexural strength, translucency, shear bond) according to established engineering and material science principles, and comparison to the characteristics of legally marketed predicate devices. It's not based on expert consensus, pathology, or outcomes data in a clinical sense for its performance metrics.

    8. The Sample Size for the Training Set

    N/A. As this is a physical device and not an AI/ML model, there is no "training set."

    9. How the Ground Truth for the Training Set Was Established

    N/A. See point 8.

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