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510(k) Data Aggregation

    K Number
    K120679
    Device Name
    SYNAPSE 3D NODULE ANALYSIS
    Manufacturer
    FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
    Date Cleared
    2012-06-01

    (87 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K120361,K042694
    Predicate For
    K243762
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synapse 3D Nodule Analysis is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Nodule Analysis accepts DICOM compliant medical images acquired from CT and PT.

    This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

    Addition to Synapse 3D Base Tools, Synapse 3D Nodule Analysis is intended to;

    • use non-contrast and contrast enhanced computed tomography (CT) images, provide custom workflows and Ul, and reporting functions for nodule analysis including boundary detection of nodules based on the location specified by the user, measurement of nodules, temporal comparison of nodule images, and fusion of a CT nodule image on a PT nodule image.
    • use positron emission tomography (PT) images, provide custom workflows and UI, and reporting functions for nodule analysis including SUV measurement of nodules with sphere VOI based on the location specified by the user, temporal comparison of nodule images, and fusion of a PT nodule image on a CT nodule image.
    Device Description

    Synapse 3D Nodule Analysis is an optional software module that works with Synapse 3D Base Tools (V3.0) (K120361, cleared on April 6, 2012). Synapse 3D Nodule Analysis, Synapse 3D Base Tools (V3.0), as well as other optional software modules, all belong to the Synapse 3D product family.

    Synapse 3D is the medical application software running on Windows server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers software tools which can be used by trained medical professionals to interpret medical images obtained from various medical devices, to create reports, or to develop treatment plans.

    The key features in Synapse 3D Nodule Analysis include boundary detection of nodules, measurement of nodules, temporal comparison of nodule images, and fusion of CT and PT nodule images on the non-contrast and contrast enhanced CT or PT images.

    Synapse 3D Nodule Analysis offers physicians the following clinical applications in addition to the features available from Synapse 3D Base Tools (V3.0) to analyze the image data retrieved from CT and PT devices.

    • . Response Evaluation Criteria in Solid Tumors (RECIST) Tracker Use non-contrast and contrast enhanced computed tomography (CT) images, provide custom workflows, user interface (UI), and reporting functions for nodule analysis including boundary detection of nodules (based on the location specified by the user), measurement of nodules, temporal comparison of nodule images, and fusion of a CT nodule image on a PT nodule image.
    • Positron Emission Response Criteria in Solid Tumors (PERCIST) Tracker . Use positron emission tomography (PT) images, provide custom workflows user interface (UI), and reporting functions for nodule analysis including standardized uptake value (SUV) measurement of nodules with sphere VOI (based on the location specified by the user), temporal comparison of nodule images, and fusion of a PT nodule image on a CT nodule image.
    AI/ML Overview

    The provided text states that the device was tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Synapse 3D Nodule Analysis software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate device. However, it does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details. That information is not present in the provided text.

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