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510(k) Data Aggregation

    K Number
    K070464
    Device Name
    ONDEMAND3D
    Manufacturer
    CYBERMED, INC.
    Date Cleared
    2007-03-16

    (28 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K032760,K033849,K022692
    Predicate For
    K102684,K103182,K113543
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OnDemand3D™ is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.

    Device Description

    OnDemand3D™ is a personal computer based dental imaging software which loads DICOM images taken from CT, MR and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis. OnDemand3D™ is designed to provide users easy and familiar user-interface. Also OnDemand3D™ makes it possible to manage medical images more easily and provides advanced tools for 2D and 3D analysis with various rendering functions.

    AI/ML Overview

    The provided 510(k) summary for CyberMed, Inc.'s OnDemand3D™ device
    does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

    The document is a submission to the FDA for 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against predefined acceptance criteria.

    Therefore, I cannot populate the requested table or answer the specific questions about standalone performance, MRMC studies, sample sizes, expert qualifications, or ground truth establishment.

    The document states:

    • Purpose: "This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92."
    • Conclusion: "CyberMed, Inc. concludes that OnDemand3D™ is safe and effective and substantially equivalent to predicate devices as described herein."

    This indicates that the submission is based on substantial equivalence, which typically does not involve the detailed performance studies with acceptance criteria that would be found for novel devices or those undergoing PMA. If such performance studies were conducted, they are not detailed in this 510(k) summary.

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