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510(k) Data Aggregation

    K Number
    K040650
    Device Name
    BONAMATES SERIES
    Manufacturer
    BIOTECH ONE, INC.
    Date Cleared
    2004-06-03

    (84 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K070737
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BONAMATES® series are indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.

    Device Description

    BONAMATES® Series

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the BONAMATES® Series, which are bone plates. It confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

    The document includes:

    • The device name: BONAMATES® Series.
    • The regulation number and name: 872.4760, Bone Plate.
    • The product code: JEY.
    • Indications for Use: Trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.

    However, it does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about a study (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance).
    • Information on how ground truth was established for training or testing sets.

    Therefore, I cannot provide the requested information based on the input given.

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