LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190503
    Device Name
    CeraSeal
    Manufacturer
    Meta Biomed Co., Ltd.
    Date Cleared
    2019-06-07

    (98 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K080917
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    · Permanent obturation of the root canal following vital pulp-extirpation

    · Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings

    CeraSeal is suitable for use in the single cone and lateral condensation technique.

    Device Description

    CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called CeraSeal, a root canal filling resin. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

    Based on the content, here's an analysis regarding acceptance criteria and supporting studies:

    1. A table of acceptance criteria and the reported device performance

      The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that would be typically seen in an AI/algorithm performance study. Instead, it lists performance tests conducted according to ISO 6876:2012, which is an international standard for root canal sealing materials. The reported device performance is that CeraSeal "conformed" to ISO 6876.

      Performance Test CategoryAcceptance Criteria (Implicit: Conformance to ISO 6876:2012)Reported Device Performance
      VisualConforms to ISO 6876:2012Conformed
      CapacityConforms to ISO 6876:2012Conformed
      PackageConforms to ISO 6876:2012Conformed
      FlowConforms to ISO 6876:2012Conformed
      Setting TimeConforms to ISO 6876:2012Conformed
      Film ThicknessConforms to ISO 6876:2012Conformed
      SolubilityConforms to ISO 6876:2012Conformed
      Radio-opacityConforms to ISO 6876:2012Conformed

      Additionally, biocompatibility tests were conducted according to ISO 10993 series and a Shelf Life test was performed, confirming conformance.

    2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

      The document does not specify a "sample size" in the context of a dataset for an AI/algorithm. The tests mentioned (biocompatibility, performance characteristics like flow, setting time, etc.) are laboratory-based and pertain to the physical and chemical properties of the material itself, not to the performance of an AI model on a dataset of patient data. Therefore, this information is not applicable to an AI device.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

      This information is not applicable. The device is a physical root canal filling material, not an AI/software device that requires expert-established ground truth on a dataset.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

      This information is not applicable, as there is no test set in the context of AI/algorithm performance requiring adjudication.

    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

      This information is not applicable. The device is a physical medical material, not an AI system intended to assist human readers.

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

      This information is not applicable. The device is not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

      This information is not applicable. The "ground truth" for this device would be its physical and chemical properties as measured against international standards (ISO 6876 for root canal filling materials and ISO 10993 for biocompatibility), rather than a clinical ground truth like pathology or outcomes data for an AI.

    8. The sample size for the training set

      This information is not applicable, as there is no AI algorithm with a training set for this device.

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

      This information is not applicable, as there is no AI algorithm with a training set for this device.

    In summary, the provided document is a 510(k) summary for a root canal filling material. It does not describe an AI/software as a medical device (SaMD) and therefore, most of the questions related to AI acceptance criteria and studies are not applicable. The "acceptance criteria" discussed are compliance with international standards for material properties and biocompatibility.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1