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510(k) Data Aggregation

    K Number
    K040421
    Device Name
    DUCERAGOLD PORCELAINS
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2004-03-18

    (29 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K931808
    Why did this record match?
    Device Name :

    DUCERAGOLD PORCELAINS

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

    Preparation of Crowns and Bridges:

    • Veneering metal framework and copings .
    • Veneering pressable ceramic .
    Device Description

    DUCERAGOLD® PORCELAINS are dental ceramic veneering preparation of crowns and bridges.
    DUCERAGOLD® PORCELAINS include Dentine, Incisal, Transparent, Correction, Powder Opaque, Redox Opaque, Glaze, Shoulder, Paste Opaque, and Bonder porcelains.

    AI/ML Overview

    The provided text is a 510(k) summary for the DUCERAGOLD® PORCELAINS, a dental ceramic veneering material. This document is a regulatory submission for premarket notification to the FDA, asserting substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or algorithm validation study would.

    Here's why and what information is available:

    • Device Type: This is a material (porcelain powders for dental use), not an AI-powered diagnostic device or a system that produces a performance metric like sensitivity or specificity. Its safety and effectiveness are typically demonstrated through material properties, biocompatibility, and comparison to existing, legally marketed materials.
    • Regulatory Pathway: A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device. This often involves showing similar technological characteristics and comparable performance, rather than conducting new, large-scale clinical trials that would generate acceptance criteria and performance data in the typical sense of measuring algorithm accuracy.

    Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable or not present in this type of regulatory document for this specific device.

    However, I can extract the relevant information that is present:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Technological Characteristics: Similar to legally marketed predicate devices.DUCERAGOLD® PORCELAINS have been used in legally marketed devices. The formulations are very similar to legally marketed predicate devices and have not changed in any way that would adversely affect biocompatibility.
    Safety and Effectiveness: Supported by prior use of components, similarity in formulations to marketed devices, and performance data.The document states: "We believe that the prior use of the components in legally marketed devices, the similarity in the formulations that the prior any marketed devices, and the performance data provided support the safety and effectiveness of DUCERAGOLD® PORCELAINS for the intended use."

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not Applicable / Not Provided: This document describes a material and its substantial equivalence to predicate devices, not a study involving a "test set" of patient data or algorithm performance. The "performance data provided" is not detailed in this summary.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not Applicable / Not Provided: No expert consensus or ground truth establishment of this nature is described, as it's not a diagnostic device.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not Applicable / Not Provided: No adjudication method is described.

    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

    • Not Applicable / Not Provided: This is not an AI-powered device, and no MRMC study is mentioned.

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

    • Not Applicable / Not Provided: This is not an algorithm, so standalone performance is not relevant.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • Not Applicable / Not Provided: Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for this type of device is typically established through material science testing (e.g., strength, durability, biocompatibility) and clinical experience with similar materials. The document implies that the safety and effectiveness are supported by the known performance of its components and similar formulations in legally marketed devices.

    8. The sample size for the training set

    • Not Applicable / Not Provided: This is not an AI algorithm, so there is no training set.

    9. How the ground truth for the training set was established

    • Not Applicable / Not Provided: As there is no training set, this question is not applicable.
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