TruPlan Computed Tomography (CT) Imaging Software
Circle Cardiovascular Imaging, Inc.TruPlan Computed Tomography (CT) Imaging Software is designed to help clinicians visualize and measure the left atrial appendage and surrounding heart structures from CT scans. It supports pre-procedural planning and post-procedural evaluation of the left atrial appendage closure (LAAC) procedure by providing segmentation, image visualization, and measurement tools. Machine learning enhances segmentation and landing zone detection for improved workflow. The software aids in clinical decision-making but does not replace existing standard care procedures.
Intended Use
TruPlan enables visualization and measurement of structures of the heart and vessels for pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure and post-procedural evaluation for the LAAC procedure.
Technology
TruPlan is a CT imaging software that uses machine learning for 3D segmentation of left heart structures and semi-automatic landing zone detection. It supports visualization techniques including 2D review, volume rendering, multiplanar reconstruction (MPR), and simulated views like TEE, ICE, and fluoroscopy. It allows manual measurements such as distance, area, angle, signal intensity, and coordinates, with reporting and annotation tools.
Performance
The device underwent rigorous software verification and validation per FDA guidance and relevant ISO standards. Machine learning algorithms were trained and validated on a large multicenter dataset (n=633), demonstrating high accuracy for left heart segmentation (99.81% bone removal, 97.37% LAA visualization) and landing zone detection (97% plane distance accuracy within 10mm). No clinical studies were required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/26/2022
4 months - 2
FDA Approval
1/18/2023
Other devices from Circle Cardiovascular Imaging, Inc.
- StrokeSENS ASPECTS Software Application2025 • 510K
- cvi42 Software Application2024 • 510K
- Cardiac CT Function Software Application2024 • 510K
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