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510(k) Data Aggregation

    K Number
    K153191
    Device Name
    Calcium Bridge
    Manufacturer
    DENALI CORPORATION
    Date Cleared
    2016-02-26

    (115 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K042819
    Why did this record match?
    Device Name :

    Calcium Bridge

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

    Calcium Bridge is a resin-based composite recommended for use as a liner or initial layer beneath all composite resins, or as flowable composite in preventive resin restorations. For Use only by a Licensed Dentist. Rx Use Only.

    Device Description

    Calcium Bridge is a resin-based, flowable polymerizable composite paste recommended as a lining material beneath composite resins or as a preventive resin restoration (PRR) material (a minimally invasive procedure to protect a tooth). A PRR restoration is not intended to prevent caries but intended to be used in the treatment of caries. Because Calcium Bridge is highly radio-opaque this allows for easy radio-graphic observation compared to enamel, dentin, and possible secondary caries.

    AI/ML Overview

    This document is a 510(k) summary for a dental device called "Calcium Bridge." It compares the device to a predicate device, "Tetric EvoCeram," to demonstrate substantial equivalence. It does not contain information about a study proving the device meets acceptance criteria related to AI or digital image analysis. Therefore, it's not possible to provide the requested information.

    The document discusses the following properties, which could be considered acceptance criteria for a dental material:

    Table of Acceptance Criteria and Reported Device Performance (as inferred from the provided test values):

    PropertyAcceptance Criteria (Predicate)Reported Device Performance (Calcium Bridge)
    Light Curing CapabilityCures Less Than 20 secondsCures Less Than 20 seconds
    Radiopacity (Aluminum Equivalent)Equal to 2.0 mm Aluminum3.5 mm Aluminum
    FluorescenceVisible Blue Glow DetectedVisible Blue Glow Detected
    Compressive Strength250 MPaGreater Than 250 MPa
    Depth of CureGreater Than 1.5 mmGreater Than 1.5 mm
    Biocompatibility (ISO 10993-5, Cytotoxicity)(N/A - Not Available for Predicate)Zone of Inhibition 0.25 cm

    Missing Information (based on your request, but not present in the document):

    The document does not describe a study involving human readers, AI, or ground truth establishment in the context of diagnostic performance. Therefore, I cannot answer the following parts of your request:

    • 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.
    • Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
    • Standalone (algorithm only) performance.
    • Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
    • Sample size for the training set.
    • How the ground truth for the training set was established.
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