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510(k) Data Aggregation

    K Number
    K243863
    Device Name
    Opulus™ Lymphoma Precision
    Manufacturer
    Roche Molecular Systems, Inc.
    Date Cleared
    2025-05-30

    (164 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K221738
    Why did this record match?
    Device Name :

    Opulus™ Lymphoma Precision

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

    Opulus™ Lymphoma Precision is a software device that uses a machine learning-based algorithm to automate segmentation and visualization of lesions along with automation of measurement of total metabolic tumor volume within whole-body FDG-PET/CT scans of patients with FDG-avid lymphomas.

    Opulus™ Lymphoma Precision is used to assist trained interpreting physicians with visualization of suspected lesions and calculation of total volume of all lesions in a body. This information can be used in addition to the standard of care image interpretation of FDG-PET/CT scans. Opulus™ Lymphoma Precision annotated images can be reviewed by an appropriately trained physician.

    The algorithm is assistive, and requires a radiologist review, who will make the final decision on FDG-PET/CT image interpretation.

    Device Description

    Opulus™ Lymphoma Precision is an assistive tool which can be used by physicians to automate the labor intensive task of quantifying disease burden in whole-body FDG-PET/CT scans of patients already diagnosed with FDG-avid lymphomas. It does so by using a machine learning methodology to localize and segment FDG-PET activity ('hot-spots' on FDG-PET scans) of lymphoma lesions within a PET/CT image. Opulus™ Lymphoma Precision does not screen for or diagnose lymphoma. It is intended for patients already diagnosed with FDG-avid lymphoma.

    The following is a list of key functionalities algorithm performs to accomplish the proposed intended use.

    • localization and segmentation,
    • visualization of lymphoma-related tumor lesions
    • quantification of Total Metabolic Tumor Volume (TMTV)

    Opulus™ Lymphoma Precision aids the efficiency of medical professionals by automatically generating tumor boundary Regions of Interest (ROIs) and quantifying TMTV, which is a tedious task when performed manually. The physician has the option to accept/reject the output generated by the device. The user does not have the ability to modify the device output.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for Opulus™ Lymphoma Precision:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly present a table of "acceptance criteria" with pass/fail thresholds. However, it does state the objectives of the performance validation study and the results that demonstrate the device's agreement and accuracy. We'll infer the implicit acceptance criteria from these objectives.

    Performance MetricAcceptance Criteria (Implicit)Reported Device Performance
    Agreement of TMTV (Cubic Root)Demonstrate an acceptable difference between aTMTV (algorithm) and mTMTV (manual ground truth).Mean difference: -0.20 cm (95% CI: -0.50, 0.10) for TMTV
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