IB NEURO, VERSION 1.0

IB NeuroTM vl.0 is an OsiriX plugin software designed to post-process and analyze dynamically acquired MR datasets by employing established algorithms to generate quantitative perfusion maps for clinical use. The device enhances existing imaging workflows by providing critical parameters such as rCBV, CBF, MTT, and TTP, derived from image intensity variations over time, to assist physicians in clinical assessments.

IB NeuroTM vl.0 is an OsiriX Plugin software designed for the advanced analysis of dynamically acquired Magnetic Resonance (MR) datasets. Its core function is to generate various parametric perfusion maps, including Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT), and Time to Peak (TTP), utilizing well-established algorithms. Key features of the software include automated correction for contrast agent leakage in rCBV maps, automated brain mask generation, normalization of parameters to normal appearing white matter (NAWM), automated report generation, per-voxel dynamic signal time course viewing, interactive Arterial Input Function (AIF) selection, and automatic export of perfusion maps as DICOM images to enhance existing medical image visualization applications. The intended use of IB NeuroTM is to facilitate the post-processing and display of these dynamic MR datasets, enabling the evaluation of image intensity variations over time for clinical applications. The software accepts data from existing MRI systems, performs quality control checks, and subsequently sends the generated parametric maps to Picture Archiving and Communication Systems (PACS) for viewing and interpretation by trained physicians. This process aims to provide information useful in clinical decision-making by leveraging platform-independent integration into existing server and workstation applications, thereby extending the productivity of current viewers, CAD workstations, and PACS.

AI Regulatory Concerns

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• Q1. What specific algorithms are employed for the automated correction of contrast agent leakage in rCBV maps, and what is their performance validation against manual or alternative established methods?; How robust is the automated brain mask generation across diverse patient anatomies, varying image qualities, and in the presence of significant neurological pathologies that might distort typical brain structures?; What is the clinical evidence or validation supporting the diagnostic or prognostic utility of perfusion parameters when normalized to normal appearing white matter (NAWM) using this specific software, particularly for different neurological conditions?; How does IB NeuroTM vl.0 account for potential variabilities in MR acquisition protocols, such as different contrast agent types, injection rates, or sequence parameters, when calculating the perfusion parameters like CBF and MTT?; Beyond generating parametric maps, are there any built-in quantitative thresholds or decision support features suggested or validated for this software to aid physicians in the interpretation of perfusion data for specific clinical scenarios, such as tumor grading or stroke assessment?