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510(k) Data Aggregation

    K Number
    K112967
    Device Name
    PMMA CAD/CAM DISC
    Manufacturer
    POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
    Date Cleared
    2012-08-28

    (328 days)

    Product Code
    EBG,REG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K080182
    Why did this record match?
    Device Name :

    PMMA CAD/CAM DISC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • fabrication of temporary crowns and bridges.
    Device Description

    PMMA CAD/CAM discs are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians. They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in A1, A2, A3, B1, B2, B3, BL3 and clear shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).

    AI/ML Overview

    Here's an analysis of the provided text regarding the PMMA CAD/CAM disc, focusing on acceptance criteria and study details.

    Important Note: The provided document is a 510(k) premarket notification summary. This type of submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical trials. Therefore, the "acceptance criteria" discussed here are primarily related to material properties and safety tests, demonstrating equivalence to the predicate, rather than clinical performance metrics typically found in efficacy studies.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Property/Test)Reported Device Performance (PMMA CAD/CAM disc)Comparison to Predicate (ZENO PMMA disc)
    CompositionHot cured polymethyl methacrylate (PMMA) and pigmentsBoth composed of polymethyl methacrylate hot cured polymer
    Indications for UseFabrication of temporary crowns and bridgesSimilar indications for use
    Physical PropertiesSimilarSimilar
    Chemical PropertiesSimilarSimilar
    E-modulusComparableComparable
    Flexural StrengthComparableComparable
    DeflectionComparableComparable
    Polymerization GradeHighHigh
    Aesthetic FunctionSame aesthetic functionSame aesthetic function
    Biocompatibility:
    - CytotoxicityTesting conductedNot explicitly stated for predicate in this summary, but a demonstration of safety is implied for equivalence.
    - SensitizationTesting conductedNot explicitly stated for predicate in this summary, but a demonstration of safety is implied for equivalence.
    - IrritationTesting conductedNot explicitly stated for predicate in this summary, but a demonstration of safety is implied for equivalence.

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

    The document does not describe a specific "test set" in the context of a clinical performance study. The equivalence is primarily based on material characterization and bench testing.

    • Sample Size: Not applicable in the context of a clinical test set. The material testing would have involved specific sample sizes for each physical/chemical property test, but these details are not provided in this summary.
    • Data Provenance: Not applicable for a clinical test set. The data would be derived from laboratory tests conducted on the PMMA CAD/CAM disc itself. No country of origin for clinical or retrospective/prospective data is mentioned as such studies were not performed for this submission.

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

    This information is not applicable as the submission is for substantial equivalence based on material properties and bench testing, not on clinical performance requiring expert ground truth for a test set.

    4. Adjudication Method for the Test Set

    This information is not applicable as there was no clinical test set requiring expert 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

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is a dental material (PMMA disc), not an AI-assisted diagnostic or therapeutic device. Therefore, no "human readers" or "AI assistance" are involved in its primary function for evaluating its effectiveness in the context of this 510(k) submission.

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

    No, a standalone algorithm performance study was not done. This is a physical dental material, not an algorithm or AI system.

    7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

    The "ground truth" for demonstrating substantial equivalence relied on:

    • Material Science Benchmarks: Comparing the physical and chemical properties of the PMMA CAD/CAM disc to those of the predicate device.
    • Biocompatibility Standards: Results from cytotoxicity, sensitization, and irritation testing, presumably against recognized standards or established safety profiles.
    • Predicate Device Characteristics: The established and legally marketed characteristics of the ZENO PMMA disc served as the primary "ground truth" for comparison.

    8. The Sample Size for the Training Set

    This information is not applicable. This submission is for a physical medical device (dental material), not a machine learning model, so there is no "training set."

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

    This information is not applicable as there is no training set for this device type.

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