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510(k) Data Aggregation

    K Number
    K153476
    Device Name
    KATANA AVENCIA Block
    Manufacturer
    Kuraray Noritake Dental, Inc.
    Date Cleared
    2016-08-23

    (265 days)

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

    KATANA AVENCIA Block

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

    Fabrication of inlays, onlays, veneers and full contour crown restorations, using a dental CAD/CAM system.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental material (KATANA AVENCIA Block) and does not contain information about the acceptance criteria or study details for an AI/ML-enabled medical device performance evaluation.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance
    2. Sample size and data provenance for the test set
    3. Number and qualifications of experts for ground truth
    4. Adjudication method
    5. MRMC comparative effectiveness study results
    6. Standalone performance details
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established

    This document is solely a regulatory clearance for a physical dental block and does not involve AI/ML software.

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