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510(k) Data Aggregation

    K Number
    K040795
    Device Name
    MULTICORE HB; MULTICORE FLOW
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2004-05-17

    (49 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MULTICORE HB; MULTICORE FLOW

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

    For Core Build-up of Vital and non-vital teeth

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for dental resin materials (MULTICORE HB and MULTICORE FLOW). It establishes substantial equivalence to existing devices and outlines regulatory requirements. However, this document does not contain the information required to answer your specific questions about acceptance criteria and the study proving device performance.

    The letter focuses on the regulatory approval process based on substantial equivalence, rather than detailing the performance studies, acceptance criteria, or statistical analyses typically associated with a clinical trial or performance evaluation for an AI/CAD system.

    Therefore, I cannot extract the following information from the provided text:

    • A table of acceptance criteria and the reported device performance
    • Sample size used for the test set and the data provenance
    • Number of experts used to establish the ground truth for the test set and their qualifications
    • Adjudication method for the test set
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
    • If a standalone (algorithm only) performance study was done
    • The type of ground truth used
    • The sample size for the training set
    • How the ground truth for the training set was established
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