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510(k) Data Aggregation

    K Number
    K053010
    Device Name
    VISTADENT AT COMPLETE, MODEL 3.1
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2005-11-22

    (27 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K043104,K982422,K012439
    Why did this record match?
    Reference Devices :

    K043104,K982422,K012439

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

    VISTADENT™ AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis.

    Device Description

    VISTADENT™ AT COMPLETE software is designed for use as an imaging database for storage and organization of orthodontic patient digital images and x-ray records. Features include resizing, cropping, and rotating of images; data and image sharing with practice management systems and digital x-ray systems; cephalometric analysis with auto-tracing capability; and virtual treatment objectives. VISTADENT™ AT COMPLETE can operate as a stand-alone software or interface with other systems software.

    AI/ML Overview

    This 510(k) submission for VISTADENT™ AT COMPLETE is a premarket notification for an imaging database software and does not contain information related to an AI/ML medical device performance study, acceptance criteria, or an MRMC comparative effectiveness study. The device is described as software for storing, organizing, manipulating, and analyzing orthodontic patient digital images and x-ray records, including cephalometric analysis with auto-tracing and virtual treatment objectives.

    Therefore, I cannot provide the requested information from the provided text, as it does not include:

    1. Acceptance criteria and reported device performance: The submission focuses on substantial equivalence to predicate devices based on technological characteristics and intended use, not on specific performance metrics or acceptance criteria for an AI/ML component.
    2. Sample size and data provenance for a test set: No test set is described.
    3. Number and qualifications of experts for ground truth: No ground truth establishment process is mentioned for evaluation.
    4. Adjudication method for the test set: Not applicable as no test set is described.
    5. MRMC comparative effectiveness study: This type of study is not mentioned. The features described (auto-tracing, virtual treatment objectives) suggest potential AI/ML capabilities, but no study evaluating human reader improvement with AI assistance is presented.
    6. Standalone performance study: No standalone performance study for an algorithm is discussed.
    7. Type of ground truth used: Not applicable as no performance evaluation study is detailed.
    8. Sample size for the training set: No training set is mentioned.
    9. How ground truth for the training set was established: Not applicable as no training set is described.

    The document is a 510(k) summary focusing on demonstrating substantial equivalence to predicate devices for a digital imaging database and analysis software, rather than reporting on the performance of a novel AI/ML algorithm against specific acceptance criteria.

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