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510(k) Data Aggregation

    K Number
    K093380
    Device Name
    MIZZY EXPRESS
    Manufacturer
    MYCONE DENTAL SUPPLY CO., INC.
    Date Cleared
    2010-03-05

    (127 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MIZZY EXPRESS

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

    For fabrication of temporary prostheses, such as crowns or bridges

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental device called "Mizzy Express." This document is not a study report and therefore does not contain information about acceptance criteria or performance studies of the type requested.

    The letter simply states that the FDA has reviewed the premarket notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This means that the manufacturer provided sufficient evidence to show that their device is as safe and effective as a device already on the market, without needing to conduct a full clinical trial or provide detailed performance data.

    Therefore, I cannot provide the requested information, including:

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

    This document serves as a regulatory clearance, not a scientific publication detailing performance studies.

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