StrokeViewer Perfusion

StrokeViewer Perfusion is an image processing software application that analyzes CT perfusion scans to provide quantitative hemodynamic parameters, such as CBF, CBV, MTT, and TMax, for adult patients suspected of ischemic stroke. It functions by processing DICOM CTP images to generate parametric maps and volume calculations of affected brain tissue, offering supplementary data for clinicians.

StrokeViewer Perfusion is an image processing software application designed to assist in the assessment of adult patients with suspected ischemic stroke by analyzing CT perfusion (CTP) scans of the brain. The software processes DICOM-compliant imaging data to provide quantitative perfusion information, generating parametric maps such as Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), Mean Transit Time (MTT), and Residue function time-to-peak (TMax). It also calculates the volume of affected tissue based on Tmax and CBF abnormalities. Intended for use by medical imaging professionals like neurologists and radiologists, the output serves as additional data to complement standard image interpretation and clinical information, and is not meant as a standalone diagnostic tool. Contraindications include inadequate contrast bolus, excessive patient motion leading to artifacts, and the presence of hemorrhage. The software operates on standard "off-the-shelf" computers or virtual platforms and is packaged as a Docker container. Results, including parametric maps and DICOM reports, are exported and can be viewed on compatible DICOM viewers. The device's efficacy was supported by non-clinical performance testing, which included software validation (unit, end-to-end, and reproducibility testing) and algorithm performance assessment using simulated datasets (Kudo digital phantom) based on tracer kinetic theory. This testing demonstrated that the device met its performance goals and acceptance criteria. Risk management was conducted according to ISO 14971:2019, and the software adhered to recognized consensus standards for medical device software and DICOM compatibility.

AI Regulatory Concerns

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• Q1. How does the algorithm's performance on the Kudo digital phantom translate to real-world clinical scenarios with varying image quality and patient presentations?; What are the specific thresholds used for Tmax and CBF abnormalities in the volume calculations, and how were these thresholds validated?; Are there any known limitations or specific patient conditions (e.g., severe motion artifacts, pre-existing lesions) where StrokeViewer Perfusion's accuracy might be compromised?; How does the processing time of StrokeViewer Perfusion compare to other perfusion analysis tools, and how does this impact its integration into time-sensitive stroke care protocols?; What future developments are planned for StrokeViewer Perfusion, particularly regarding the potential inclusion of MR perfusion data analysis or AI-driven predictive analytics?