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510(k) Data Aggregation

    K Number
    K994144
    Device Name
    TOOTHBRUSH WASH
    Manufacturer
    CAL HUECH, INC.
    Date Cleared
    2000-03-02

    (86 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TOOTHBRUSH WASH

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

    This product is intended to be used as an accessory to cleaning a toothbrush.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

    The document is a 510(k) clearance letter from the FDA for a "Toothbrush Wash" device. It primarily states that the device has been found substantially equivalent to a predicate device and can therefore be marketed.

    It does not contain any information regarding:

    • Acceptance criteria for device performance.
    • A study that demonstrates the device meets specific performance criteria.
    • Sample sizes used for testing or training sets.
    • Data provenance or details about ground truth establishment.
    • Information about expert involvement or adjudication methods.
    • Details on MRMC studies or standalone algorithm performance.

    Therefore, I cannot populate the requested table and answer the subsequent questions.

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