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510(k) Data Aggregation

    K Number
    K041718
    Device Name
    KELES FACEMASK
    Manufacturer
    GREAT LAKES ORTHODONTICS, LTD.
    Date Cleared
    2004-10-15

    (113 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KELES FACEMASK

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

    The Keles protraction face mask is used in the treatment of patients with Class III The Keles profitaction facc mask is used in the neationed maxilla. The facemask is especially useful in patients with an anterior bite tendency or condition.

    Device Description

    The Keles Facemask is an orthodontic headgear device. All components have been used in legally marketed devices or have been found to be safe for dental use.

    AI/ML Overview

    This submission is a 510(k) premarket notification for a Class II medical device, the Keles Facemask, an orthodontic headgear. The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective. Therefore, there are no specific "acceptance criteria" in the sense of performance metrics (like sensitivity, specificity, accuracy) for an AI model or a new diagnostic technology.

    Instead, the "acceptance criteria" are related to demonstrating substantial equivalence in design, materials, manufacturing, and intended use to a predicate device. The "study" that proves the device meets these criteria is the submission itself, which provides a detailed comparison to the predicate device.

    Here's an analysis based on the provided document:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (for 510(k) Substantial Equivalence)Reported Device Performance (as demonstrated in submission)
    Intended Use: Device is intended for the same use as the predicate.The Keles Facemask is intended for the treatment of patients with Class III malocclusions, especially useful in patients with an anterior bite tendency or condition. This matches the implied intended use of similar orthodontic extraoral headgear.
    Technological Characteristics: Device has similar technological characteristics to the predicate."The Keles Facemask and predicate consists of similar extraoral and intraoral components." All components have been used in legally marketed devices or have been found to be safe for dental use.
    Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety or effectiveness.The submission concludes: "We conclude that the similarity in design between the Keles Facemask and the predicate device supports the safety and effectiveness of the Keles Facemask for the indicated uses." The FDA's clearance letter confirms their agreement with this conclusion.

    2. Sample size used for the test set and the data provenance

    • Not applicable. This submission is for a physical medical device (orthodontic headgear), not a data-driven device like an AI algorithm. Therefore, there is no "test set" of patient data in the context of an AI study. The determination of substantial equivalence relies on a comparison of device characteristics, materials, and intended use.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not applicable. See point 2. The "ground truth" here is established by regulatory standards and expert opinion within Great Lakes Orthodontics regarding the safety and effectiveness of their design compared to a known safe and effective predicate device.

    4. Adjudication method for the test set

    • Not applicable. See point 2. The regulatory review process itself involves expert review by the FDA, who adjudicates the submitted evidence for substantial equivalence.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not applicable. This device is a physical orthodontic device, not an AI diagnostic tool.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not applicable. This device is a physical orthodontic device, not an AI algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • The "ground truth" for this type of submission is the established safety and effectiveness of the legally marketed predicate device. The manufacturer asserts, and the FDA concurs, that the Keles Facemask is substantially equivalent to this predicate, implying it meets the same safety and effectiveness standards.

    8. The sample size for the training set

    • Not applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in this context.

    9. How the ground truth for the training set was established

    • Not applicable. See point 8.
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