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510(k) Data Aggregation

    K Number
    K131753

    Validate with FDA (Live)

    Device Name
    MERIDIAN
    Manufacturer
    AB ARDENT
    Date Cleared
    2013-11-14

    (153 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Abbreviated
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K042819
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Meridian is a direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth.

    Device Description

    Meridian is a light curing universal dental composite material of the latest nanohybrid type having an optimized chemical composition.

    AI/ML Overview

    The provided text describes a 510(k) submission for a dental composite material named Meridian. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel performance against specific acceptance criteria using clinical studies with complex statistical methodologies often seen for other types of medical devices.

    Therefore, many of the requested sections are not applicable to this type of device and submission. Based on the provided information, here's what can be extracted:

    1. Table of Acceptance Criteria and Reported Device Performance

    For this device, "acceptance criteria" are defined by the performance standards outlined in ISO 4049:2009 for polymer-based dental restorative materials, and the "reported device performance" demonstrates that Meridian meets these standards and is substantially equivalent to the predicate device (Tetric EvoCeram, K042819).

    Acceptance Criteria (ISO 4049:2009 Performance Parameters)Reported Device Performance (Meridian)Study Proving Acceptance
    Water AbsorptionMeets ISO 4049:2009 standardsTesting Summary states: "The device was tested in accordance with ISO 4049:2009 for Polymer based dental restorative materials for Water Absorption, Water solubility, Radiopacity, Flexural Strength, Depth of Cure. Modulus of Elasticity, and Compressive Strength and the results from testing demonstrates that Meridian is substantially equivalent to the predicate device."
    Water SolubilityMeets ISO 4049:2009 standards
    RadiopacityMeets ISO 4049:2009 standards
    Flexural StrengthMeets ISO 4049:2009 standards
    Depth of CureMeets ISO 4049:2009 standards
    Modulus of ElasticityMeets ISO 4049:2009 standards
    Compressive StrengthMeets ISO 4049:2009 standards
    BiocompatibilityMeets ISO 10993 standardsTesting Summary states: "Biocompatibility testing and evaluation was also carried out according to ISO 10993."

    2. Sample size used for the test set and the data provenance

    The document does not specify the sample sizes used for the in vitro tests conducted according to ISO 4049:2009 and ISO 10993. These are laboratory-based material tests, not clinical studies involving patient data. Therefore, concepts like "country of origin of the data" or "retrospective or prospective" are not applicable.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable. The ground truth for this device is based on standardized laboratory testing protocols (ISO 4049:2009, ISO 10993), not on expert consensus or clinical interpretation.

    4. Adjudication method for the test set

    Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpretation of results, typically involving human readers. This device underwent in vitro material testing.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable. This is a dental composite material, not an AI-powered diagnostic device. No MRMC studies were performed.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

    Not applicable. This is a material, not an algorithm.

    7. The type of ground truth used

    The ground truth used for this device is the physical and chemical properties of the material as measured by standardized, objective laboratory tests defined by international standards (ISO 4049:2009 for performance, ISO 10993 for biocompatibility). The comparison is against the predicate device, showing "substantial equivalence" based on these measurements.

    8. The sample size for the training set

    Not applicable. This is not an AI/ML device that requires a training set. The "training" for this device involved meeting established material standards.

    9. How the ground truth for the training set was established

    Not applicable. As above, this is not an AI/ML device.

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