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510(k) Data Aggregation

    K Number
    K231387
    Device Name
    Endofill
    Manufacturer
    Lumendo AG
    Date Cleared
    2023-07-10

    (59 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K211995,K071106
    Why did this record match?
    Device Name :

    Endofill

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

    Endofill (1) is indicated for the permanent obturation of root canals following root canal treatment

    Device Description

    Endofill is a hydrophilic, radiopaque material intended for permanent obturation of the root canals following root canal treatment. It consists of a liquid, flowable material that is injected into the prepared and cleaned root canal and converted into a solid polymer by photocuring. The cured material remains within the root canal to obturate (seal) it.
    Endofill is provided ready-to-use in single-use plastic syringes which are sealed inside aluminum-laminate pouches.
    The Endofill material is the only part of the device that directly contacts the tissue. The syringe in which the material is provided comes in contact with Endofill material, so it contacts the tissue indirectly.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for Lumendo AG's "Endofill" device, a root canal filling resin. It outlines the device's intended use, technological characteristics, and comparison to predicate devices, along with the non-clinical testing performed. However, it does not contain information about acceptance criteria, the specific study conducted to prove the device met those criteria, or details regarding expert involvement, ground truth establishment, or sample sizes related to AI/human reader performance.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets these criteria, as the requested details are not present in the provided document.

    The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench performance testing and compliance with recognized standards.

    Here's what can be extracted from the document regarding the non-clinical testing:

    Non-Clinical Test Summary & Conclusions (as reported in the document):

    • Acceptance Criteria & Reported Performance: The document states that Endofill complies with the performance requirements set out in ISO 6876:2012. The specific measured values for each criterion are not provided in this summary, but the general compliance serves as the "reported device performance" in relation to the standards' acceptance criteria.

      Acceptance Criteria (from ISO 6876:2012)Reported Device Performance
      Flow (as per ISO 6876:2012)Complies with ISO 6876:2012
      Film thickness (as per ISO 6876:2012)Complies with ISO 6876:2012
      Solubility & Disintegration (as per ISO 6876:2012)Complies with ISO 6876:2012
      Radiopacity (as per ISO 6876:2012)Complies with ISO 6876:2012
      Biocompatibility (ISO 10993-1:2018 & ISO 7405:2018)Complies with ISO 10993-1:2018 & ISO 7405:2018

    • Sample size used for the test set and data provenance: Not specified in the provided text for the non-clinical bench testing.

    • Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as this was non-clinical bench testing, not a human reader or AI performance study.

    • Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as this was non-clinical bench testing.

    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned. The study described is non-clinical bench testing.

    • If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is a physical dental material, not an algorithm.

    • The type of ground truth used: For the non-clinical bench testing, the "ground truth" are the standardized test methods and limits defined in ISO 6876:2012 for the physical-chemical properties, and ISO 10993-1:2018 and ISO 7405:2018 for biocompatibility.

    • The sample size for the training set: Not applicable, as this is a physical device, not an AI/ML algorithm.

    • How the ground truth for the training set was established: Not applicable.

    In summary, the document details a 510(k) submission for a medical device (root canal filling resin), demonstrating its substantial equivalence through mechanical and chemical property testing against international standards (ISO 6876:2012, ISO 10993-1:2018, ISO 7405:2018). It does not involve AI, human reader studies, or complex clinical study designs typically associated with software as a medical device (SaMD) or AI-enabled technologies.

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