Opulus™ Lymphoma Precision
Roche Molecular Systems, Inc.Opulus™ Lymphoma Precision is an AI-powered software tool designed to help physicians analyze whole-body FDG-PET/CT scans of patients with FDG-avid lymphomas. It automatically segments and visualizes lymphoma lesions and calculates the total metabolic tumor volume. This supports physicians by reducing the manual workload and assisting in more efficient interpretation of PET/CT images, although final decisions remain with the radiologist.
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. It is used to assist trained interpreting physicians with visualization of suspected lesions and calculation of total volume of all lesions in a body. The algorithm is assistive and requires radiologist review for final interpretation.
Technology
The device uses a machine learning methodology to localize and segment lymphoma lesions exhibiting FDG-avidity on PET/CT images. It automatically generates tumor boundary regions of interest (ROIs) and quantifies total metabolic tumor volume (TMTV). It outputs overlay images with segmentation masks and volumetric measurements, assisting but not replacing physician review.
Performance
Performance was validated on 182 independent patient FDG-PET/CT scans from multiple geographic locations and scanner types. Manual ground truth was established by three expert radiologists per scan. The device demonstrated good agreement with manual measurements of total metabolic tumor volume (mean difference ~ -0.2 cm) and lesion segmentation accuracy (mean Dice Similarity Coefficient of 0.70).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/17/2024
5 months - 2
FDA Approval
5/30/2025
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