Volta AF-Xplorer
Volta MedicalVolta AF-Xplorer is a medical software device that helps doctors analyze and annotate electrical signals from the heart in real-time. It uses machine learning to detect areas in the atria that exhibit abnormal electrical patterns during atrial fibrillation or tachycardia, supporting catheter ablation procedures. This software integrates with cardiac mapping systems to improve the precision and efficiency of cardiac electrophysiology interventions.
Intended Use
The Volta AF-Xplorer assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.
Technology
Machine and deep learning-based algorithm software that processes analog or digital intra-cardiac electrogram signals along with 3D electrode positioning from compatible electrophysiology recording and 3D mapping systems. Analyzes signals in real-time to annotate dispersed electrograms and output graphical results for operator guidance, either manually or automatically tagging in 3D mapping systems.
Performance
Software design verification was performed using pre-processing from predicate VX1 and post-processing from VX1+. Bench testing included rigorous software verification and validation, demonstrating equivalent performance to predicate devices. This supports the device's safety and effectiveness for its intended use.
Predicate Devices
No predicate devices specified
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