FEops HEARTguide™ ALPACA is an AI-enabled medical imaging software system that helps clinicians visualize and measure detailed heart and vessel structures from CT images. It aids in planning minimally invasive heart procedures by providing automated segmentation, 3D visualization, measuring tools, and reporting. This software supports better procedural decisions by combining anatomical insights with clinical evaluation.
Intended Use
FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions.
Technology
Software uses AI including nonadaptive machine learning algorithms for automatic and supervised segmentation of cardiovascular structures, provides 2D and 3D visualization, measurement, annotation, and reporting tools. Delivered as a cloud-based system with human oversight on AI outputs.
Performance
Non-clinical validation was performed on retrospective cohorts (35 cases each for LAAO and TAVI) comparing AI outputs with manual ground truth annotations. Performance goals for key landmarks (landing zone diameter for LAAO within ±18%, aortic annulus diameter for TAVI within ±10%) were met based on Bland-Altman analysis. Dice similarity scores for segmentations were high (mean ~0.93-0.98). Testing showed safety, effectiveness, and substantial equivalence to predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/23/2022
5 months - 2
FDA Approval
6/6/2023
Other devices from FEops nv
- FEops HEARTguide2021 • DE NOVO
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