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510(k) Data Aggregation

    K Number
    K972943
    Device Name
    AURECAST 92
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-16

    (88 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AURECAST 92

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

    Dental casting alloy for making restoration.

    Device Description

    High gold casting alloy

    AI/ML Overview

    I am sorry, but the provided text describes a 510(k) submission for a dental casting alloy named AURECAST 92. This document is a regulatory submission for a material, not a medical device that would involve a study with acceptance criteria, sample sizes, expert ground truth, or human-in-the-loop performance as you've requested.

    The document focuses on comparing the AURECAST 92 alloy to a legally marketed predicate device (Argenco Bio10) based on composition, physical, and mechanical properties. The acceptance is based on the substantial equivalence of these material properties, rather than performance metrics of a device against specific clinical or diagnostic criteria.

    Therefore, I cannot extract the information required for the table and bullet points you provided, as those concepts (like sample size for test sets, ground truth by experts, MRMC studies, standalone performance) are not applicable to the type of device and submission described in the text.

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