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510(k) Data Aggregation

    K Number
    K032662
    Device Name
    GUTTAFLOW
    Manufacturer
    COLTENE/WHALEDENT GMBH & CO. KG
    Date Cleared
    2003-11-03

    (67 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K973539
    Why did this record match?
    Device Name :

    GUTTAFLOW

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

    GuttaFlow is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.

    Device Description

    GuttaFlow is a Class II, permanent root canal filling material. GuttaFlow is silicone based (Polydimethysiloxane) and consists additionally of Gutta Percha, Zinc oxide, Zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for GuttaFlow based on the provided FDA 510(k) summary:

    This device is cleared through the 510(k) pathway, which relies on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria and performance measures in the same way a PMA device would. Therefore, much of the requested information regarding detailed study design, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment as it relates to a "device performance study" might not be applicable in the traditional sense for this type of submission.

    Instead, the "study" demonstrating adherence to acceptance criteria is primarily a comparison against a legally marketed predicate device, focusing on technical characteristics and intended use.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Based on Substantial Equivalence to Predicate)Reported GuttaFlow Performance
    Material CompositionSilicone based (Polydimethysiloxane) with Gutta Percha, Zinc oxide, Zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid. (Similar to predicate, with specific additions/differences noted).
    BiocompatibilityVery similar to predicate device RoekoSeal. (Implied to meet the same biocompatibility standards as the predicate, which is a Class II device).
    Dimension StabilityVery similar to predicate device RoekoSeal.
    FlowVery similar to predicate device RoekoSeal.
    Film ThicknessVery similar to predicate device RoekoSeal.
    SolubilityVery similar to predicate device RoekoSeal.
    ResorbabilityNot resorbable. (Consistent with predicate).
    Intended UsePermanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal. (Matches the predicate's intended use for root canal filling materials, classified under 21 CFR 872.3820).
    Curing TimeDifferences in curing time compared to predicate. (This is noted as a difference, implying it's acceptable as long as the change does not raise new questions of safety or effectiveness and the device still functions as intended).
    Addition of Gutta Percha and Zinc OxideAdded to the formulation compared to the predicate. (This difference is acknowledged and accepted, as it does not change the fundamental safety or effectiveness profile as a root canal filling material, but rather provides features or properties potentially perceived as upgrades or differentiators).

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

    • Sample Size for Test Set: Not explicitly stated in the provided summary. For a 510(k), the "test set" primarily refers to samples used for in vitro bench testing to demonstrate technical equivalence, rather than a clinical trial with a patient test set. No clinical studies are referenced.
    • Data Provenance: Not explicitly stated. Given it's a 510(k) submission primarily comparing technical characteristics to a predicate, the data would likely be from internal laboratory testing conducted by the manufacturer (Coltène/Whaledent GmbH & Co. KG). It would be retrospective in the sense that it's comparing against existing data for the predicate and generating new data for GuttaFlow, but not a prospective clinical trial. The country of origin for the data would likely be related to the manufacturer's location, which is Germany.

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

    • This information is not applicable/not provided in this 510(k) summary. For a 510(k) based on substantial equivalence to a predicate, the "ground truth" for device performance is generally established through recognized standards, predicate device performance data, and scientific principles, not through expert consensus on a clinical test set.

    4. Adjudication Method for the Test Set

    • This information is not applicable/not provided. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.

    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

    • This information is not applicable/not provided. This device (GuttaFlow) is a dental material, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

    • This information is not applicable/not provided. As mentioned above, this is a dental material, not an algorithm or AI system.

    7. The Type of Ground Truth Used

    • The "ground truth" in this context is based on technical specifications, established material properties, and the performance profile of the legally marketed predicate device (RoekoSeal). Equivalence is demonstrated by showing that GuttaFlow's technical characteristics, biological properties, and intended use are "substantially equivalent" to those of the predicate device, which itself has an established safe and effective use history. This also includes adherence to relevant dental material standards (though not explicitly listed, they would be implicit in the assessment of such properties).

    8. The Sample Size for the Training Set

    • This information is not applicable/not provided. There is no mention of a "training set" in the context of machine learning or AI for this dental material device.

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

    • This information is not applicable/not provided. As there is no training set mentioned, there's no ground truth establishment for it.
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