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510(k) Data Aggregation

    K Number
    K071590
    Device Name
    THERMA-CURE
    Manufacturer
    RELIANCE ORTHODONTIC PRODUCTS, INC.
    Date Cleared
    2007-07-31

    (50 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K880793
    Why did this record match?
    Device Name :

    THERMA-CURE

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

    Therma-Cure is a heat cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the indirect bonding of orthodontic brackets and appliances.

    Device Description

    Therma-Cure™ is a heat curable orthodontic adhesive used for the indirect bonding of orthodontic brackets and appliances.

    AI/ML Overview

    The provided text describes the 510(k) summary for the device "Therma-Cure™", a heat-curable orthodontic adhesive, and its comparison to a predicate device, "Light Bond™ Orthodontic Adhesive". The study focused on demonstrating substantial equivalence, primarily through performance testing.

    Here's an analysis of the acceptance criteria and study information:

    Acceptance Criteria and Reported Device Performance

    PropertyAcceptance Criteria (Implied by Predicate Performance)Reported Device Performance (Therma-Cure)
    Intended UseLight Cure Adhesive for indirect bonding (as per predicate device, Light Bond)Heat Cure Adhesive for indirect bonding
    Mechanical / Physical PropertiesSingle paste in a hand-held delivery (as per predicate device, Light Bond)Single paste in a hand-held delivery
    Chemical CompositionBisphenol A Diglycidyl Methacrylate / Urethane Dimethacrylate Resin Monomer and Silica Filler Triethyleneglycol Dimethacrylate Diluent 2-3-Di-tert-butyl-4-methylphenol Inhibitor (as per predicate device, Light Bond)Bisphenol A Diglycidyl Methacrylate resin Monomer and Silica Filler Triethyleneglycol Dimethacrylate Diluent 2-3-Di-tert-butyl-4-methylphenol Inhibitor
    Shear Bond StrengthNot explicitly stated as a numerical acceptance criterion, but the implied criterion is similar performance to the predicate device, Light Bond, when tested using an in-vivo performance test method. This means the shear bond strength should be within an acceptable range of the predicate, indicating comparable adhesive strength for orthodontic bracket retention.The study reported "similar performance" to the predicate device for shear bond strength using an in-vivo performance test method. No specific numerical values were provided.
    Non-toxicityThe device must be non-toxic, conforming to applicable biocompatibility standards. The implied acceptance criterion would be passing the requirements of ISO 10993-5 (tests for in vitro cytotoxicity).Therma-Cure has been proven to be non-toxic when tested according to ISO 10993-5.

    Study Details

    1. Sample Size Used for the Test Set and Data Provenance:

      • Sample Size: "replicates of 5 for both Therma-Cure and Light Bond" were used for the shear bond strength testing. This means 5 samples for the Therma-Cure device and 5 samples for the Light Bond device, for a total of 10 samples in the test.
      • Data Provenance: The study states "in-vivo performance test method". While it doesn't explicitly state the country of origin, the FDA submission context implies the data would be relevant to U.S. regulatory standards. It is a prospective study as it involves conducting new tests for regulatory submission.

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

      • This information is not provided in the given text. The study describes "in-vivo performance test method" for shear bond strength, which is a laboratory or clinical measurement rather than an expert interpretation task. For the non-toxicity test, reference to ISO 10993-5 implies standard toxicology protocols were followed, not expert consensus on ground truth.

    3. Adjudication Method for the Test Set:

      • Not applicable. The tests described are objective performance measurements (shear bond strength, non-toxicity) rather than subjective assessments requiring adjudication among experts.

    4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • No. This was not an MRMC study. The device is an orthodontic adhesive, not an AI-powered diagnostic tool. Therefore, human reader improvement with or without AI assistance is not relevant to this submission.

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

      • Not applicable. The device is a physical product (adhesive), not an algorithm or AI system.

    6. The Type of Ground Truth Used:

      • For Shear Bond Strength: The ground truth was established through a direct, objective measurement using an "in-vivo performance test method." The predicate device's performance served as the comparative "ground truth" for demonstrating substantial equivalence.
      • For Non-Toxicity: The ground truth was established by adherence to the objective test standards outlined in ISO 10993-5.

    7. The Sample Size for the Training Set:

      • Not applicable. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in this context.

    8. How the Ground Truth for the Training Set Was Established:

      • Not applicable. As there is no training set for a physical adhesive, this question does not apply.
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