MRCP+ v1.0

MRCP+v1 is an image processing software designed for the non-invasive, quantitative assessment of biliary system structures by generating three-dimensional models and associated metrics from MRCP DICOM images. Its methodology utilizes user-assisted segmentation and automated analysis to measure bile duct widths, volumes, and regions of variation, thereby providing supplementary information to clinicians for hepatobiliary evaluation.

MRCP+v1 is a standalone software device designed to assist trained operators in the quantitative assessment of biliary system structures using Magnetic Resonance Cholangiopancreatography (MRCP) images. The software processes DICOM 3.0 compliant MRCP datasets from a single patient visit to generate three-dimensional models of fluid-filled tubular structures in the abdomen, including the intra-hepatic and extra-hepatic biliary tree, pancreatic duct, and gallbladder. Its methodology relies on user-initiated seeding points for interactive segmentation and labelling of these structures. The core science involves calculating quantitative metrics such as bile duct widths, regional volumes of segmented structures, and the automatic detection of regions of variation (ROV) within tubular structures. These outputs are presented in a summary report intended to supplement conventional radiological assessments, providing additional data for radiologists and clinicians to aid in the evaluation and diagnosis of hepatobiliary conditions. The performance of MRCP+v1 was evaluated through bench and in-vivo testing. Algorithmic accuracy using digital synthetic phantoms showed 95% limits of agreement for duct measurements within ±1.3mm. Device accuracy with physical phantoms demonstrated similar precision, typically within ±1.1mm. Precision studies on physical phantoms indicated high repeatability (e.g., clinical phantom LoA ±0.4mm) and reproducibility (e.g., clinical phantom LoA +0.5mm to -1.1mm). In-vivo testing on data from volunteers, across various MR scanners and field strengths, confirmed high repeatability and reproducibility for metrics such as biliary tree volume (reproducibility LoA +4.7 to -6.9 ml), gallbladder volume, and duct diameter measurements (median duct reproducibility LoA +2.6 to -2.8 mm). Intra-operator and inter-operator variability studies showed that operator-induced variations were within acceptable limits, supporting consistent performance.

AI Regulatory Concerns

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• Q1. How does the 'automatic detection of regions of variation (ROV)' algorithm function, and what are its validated sensitivity and specificity for clinically significant biliary variations compared to expert radiologist interpretation?; What specific MRCP acquisition protocols and parameters (e.g., sequence types, resolution, slice thickness) are recommended or required for optimal input into MRCP+v1, and how robust is the software to variations in image quality or acquisition parameters?; The in-vivo performance testing utilized data from volunteers; what were the characteristics of the patient cohort (e.g., specific hepatobiliary diseases, severity) used to validate the device's utility in a clinical setting with pathology?; To what extent does the accuracy and reproducibility of the quantitative measurements, particularly bile duct widths and volumetric analysis, depend on the operator's skill and consistency in placing seeding points for segmentation?; Are there comparative studies demonstrating the clinical impact of using MRCP+v1, such as improvements in diagnostic accuracy, changes in treatment planning, or enhanced inter-observer agreement among radiologists for biliary system assessment?