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510(k) Data Aggregation

    K Number
    K991490
    Device Name
    ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    1999-07-15

    (78 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K991489
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Alginate Impression Material II with water is used as a dental impression material.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information regarding the acceptance criteria or any study that proves the device meets specific performance criteria.

    The document is a 510(k) clearance letter from the FDA for "Alginate Impression Material II". This letter primarily states that the device is substantially equivalent to a previously marketed device. It does not contain details about specific performance metrics, clinical studies, or the methodologies used to establish such performance.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance.
    3. Number or qualifications of experts.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance details.
    7. Type of ground truth used.
    8. Training set sample size.
    9. How training set ground truth was established.

    The document focuses on regulatory clearance through substantial equivalence, not on a detailed presentation of performance data or study design.

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