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510(k) Data Aggregation

    K Number
    K032892
    Device Name
    MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2003-09-26

    (9 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K011560
    Predicate For
    K072713,K143033
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Trubyte® Denture Base Resin System is indicated for:

    1. Fabrication of dentures, appliances and prostheses
    2. Repair of dentures, appliances and prostheses
    3. Relining of denture surfaces
    Device Description

    The TRUBYTE® DENTURE BASE RESIN SYSTEM is composed of five resin formulations: a denture baseplate resin, contour resin, clear resin, clear resin, and resilient resin. The finished denture base is constructed from a laminate of these resins that are light cured. These new materials bypass the usual "lost wax" process and allow the dentist and technician to develop a trial denture that will become the final denture. It will not be necessary to fabricate a mold or "invest" the trial denture.

    AI/ML Overview

    This document is a 510(k) Pre-market Notification for the Trubyte® Denture Base Resin System. It's a regulatory submission to the FDA, not a study report detailing performance against acceptance criteria in the way a clinical trial or algorithm validation study would.

    Therefore, the requested information elements (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC study, standalone performance, training set details) cannot be extracted from the provided text.

    Here's why and what information can be inferred:

    Key Takeaways from the Document:

    • Device Type: Trubyte® Denture Base Resin System (a light-cured resin system for dentures).
    • Regulatory Pathway: 510(k) Pre-market Notification, indicating a claim of substantial equivalence to a predicate device.
    • Predicate Device: Trubyte® Denture Base Resin System (K011560), implying the new system is an update or variant of an already cleared device.
    • Basis for Equivalence:
      • The components of the new resin system have been used in legally marketed devices or found safe for dental use.
      • Biocompatibility testing (cytotoxicity, mutagenicity, irritation, sensitization) was performed on the resilient resin (uncured and cured) and passed. This is the closest the document comes to experimental "acceptance criteria" and "performance."
    • Intended Use: Fabrication, repair, and relining of dentures, appliances, and prostheses. These are the same as the predicate device.

    Why the Requested Information Cannot Be Provided from This Document:

    1. Acceptance Criteria & Reported Performance Table: The document states that the resilient resin passed biocompatibility testing. It does not list specific numerical acceptance criteria (e.g., cytotoxicity index < X, irritation score < Y) or detailed quantitative results (e.g., cytotoxicity index = Z). It only offers a qualitative "passed."
    2. Sample Sizes & Data Provenance: No information on the number of samples used for biocompatibility testing is provided, nor the source of any data beyond it being "biocompatibility data."
    3. Number/Qualifications of Experts for Ground Truth: Not applicable. Biocompatibility testing typically involves in-vitro or in-vivo methodologies, not human expert consensus on diagnostic images or clinical outcomes.
    4. Adjudication Method: Not applicable for biocompatibility testing.
    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating observer performance (e.g., radiologists, pathologists) with and without AI assistance for diagnostic tasks. This device is a material for manufacturing dentures, not a diagnostic tool.
    6. Standalone Performance: While the biocompatibility testing evaluates the material itself (standalone), it's not a "standalone algorithm performance" in the context of AI/software.
    7. Type of Ground Truth: The "ground truth" here is the outcome of standardized biocompatibility tests.
    8. Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
    9. How Ground Truth for Training Set Was Established: Not applicable.

    In summary, this document is a regulatory submission demonstrating substantial equivalence for a dental material, relying on a history of safe use of its components and basic biocompatibility testing, not a detailed scientific study with the types of performance metrics and validation frameworks typically seen for software or diagnostic devices.

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