TribusConnect
TribusMed Beheer BVTribusConnect is a cloud-based software application that allows medical professionals to remotely view, manipulate, and measure CT images stored in DICOM format. It features machine learning algorithms for heart segmentation and semi-automated localization of the Left Atrial Appendage, assisting in cardiac intervention planning and analysis. The software enhances clinical workflows by enabling secure, interactive image review on various devices but is not intended for diagnosis on mobile displays or as a primary image archive.
Intended Use
TribusConnect is a medical image management and processing device which facilitates remote viewing on different locations of CT images stored in DICOM format, allowing healthcare professionals to access, review, manipulate, measure and visualize simulated patient data from different sources. Suitable for pre-procedural planning and post procedural analysis of cardiac interventions, using ML-based heart segmentation and other CT renderings. Not intended for diagnostic use on mobile displays or as primary archive.
Technology
TribusConnect is a cloud-based software with components including a cloud server for rendering and DICOM data management, and a web-based viewer accessible via standard browsers on desktops, tablets, and mobiles. It features ML-based heart segmentation and semi-automated localization of the Left Atrial Appendage from CT DICOM data, providing various renderings such as volume rendering, simulated fluoroscopy, MIP, MPR, and supports measurements on MPR views.
Performance
Performance testing included software verification per FDA guidance, phantom studies validating measurement accuracy within 5%, cybersecurity penetration testing without major issues, and clinical validation of ML algorithms using 100 CTA volumes from multiple sites with expert review demonstrating high accuracy in heart segmentation and LAA localization. No new risks were identified compared to predicate devices.
Predicate Devices
No predicate devices specified
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