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510(k) Data Aggregation

    K Number
    K133182
    Device Name
    HTFX-222
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2014-04-09

    (174 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K123631,K082434,K091388,K032921,K042819
    Why did this record match?
    Device Name :

    HTFX-222

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Liner or base
    2. Blocking out undercuts
    3. Repair of direct and indirect aesthetic restorations: composites, veneers, crowns and bridges (including temporary crowns and bridges), defect margins when margins are in enamel
    4. Sealing hypersensitive areas
    5. Fissure sealant
    6. Direct restorative for small Class I, II, III, IV, and V cavities
    Device Description

    HTFX-222 is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is a universal type. The material is available in 8 shades: A1, A2, A3, A3.5, A4, A02, AO3 and CV

    AI/ML Overview

    The provided document is a 510(k) summary for a dental resin material, HTFX-222. It focuses on demonstrating substantial equivalence to predicate devices rather than describing a performance study of an AI-powered diagnostic device. Therefore, the specific information requested about acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable to this document.

    However, I can extract the information that is present regarding the device's technical specifications and how its performance was verified against an industry standard.

    Here's the information that can be extracted:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are derived from the international standard ISO 4049:2009 (Dentistry - Polymer-based restorative materials). The document states that the device was tested and confirmed to meet these requirements.

    Acceptance Criteria (from ISO 4049:2009)Reported Device Performance (HTFX-222)
    Sensitivity to ambient lightConforms to Required Specifications
    Depth of cureConforms to Required Specifications (Differences noted from predicates)
    Flexural strengthConforms to Required Specifications (Differences noted from predicates)
    Water sorptionConforms to Required Specifications (Differences noted from predicates)
    SolubilityConforms to Required Specifications
    Color stability after irradiation and water sorptionConforms to Required Specifications
    RadiopacityConforms to Required Specifications

    Note: The document explicitly states, "It is confirmed that the device conforms to the required specifications of ISO 4049:2009 and is suitable for its intended use." Differences in Depth of Cure, Flexural Strength, and Water Sorption are noted when compared to predicate devices, but the implication is that these still fall within the acceptable parameters of ISO 4049.

    2. Sample Size Used for the Test Set and Data Provenance

    Not applicable. This is a material science study, not a study involving patient data or a "test set" in the context of an AI device. The tests are performed on material specimens.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    Not applicable. Ground truth for material properties is established through standardized laboratory testing methods defined by ISO 4049:2009, not by expert consensus in the typical sense of medical image interpretation.

    4. Adjudication Method for the Test Set

    Not applicable. Material property tests are objective measurements, not subject to adjudication by multiple parties.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No. This is not an AI-powered diagnostic device, so an MRMC study is not relevant.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    No. This is a material, not an algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for the performance of HTFX-222 is based on standardized laboratory measurements and accepted industry specifications as defined by ISO 4049:2009. These are objective physical and chemical properties of the material.

    8. The Sample Size for the Training Set

    Not applicable. This is a material testing document, not a machine learning study. There is no "training set."

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. As there's no training set, this question is not relevant.

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