TruPlan

TruPlan is a computed tomography (CT) imaging software designed for pre-procedural planning of Left Atrial Appendage Closure (LAAC) by enabling visualization and manual measurement of cardiac structures. It utilizes user-uploaded CT data and machine learning for 3D visualization to aid clinicians in assessing LAA anatomy and selecting appropriately sized closure devices.

TruPlan is a Computed Tomography (CT) imaging software application designed as a medical device to assist qualified users in the pre-operative planning of Left Atrial Appendage Closure (LAAC) procedures. Its primary function is to support the anatomical assessment of the Left Atrial Appendage (LAA), including its size, shape, and relationship with adjacent cardiac and extracardiac structures, which helps physicians determine the appropriate size for a closure device. Users manually upload pre-existing CT images into the standalone Windows-based software. TruPlan offers various visualization modules, including LAA, simulated fluoroscopy, Transesophageal Echo (TEE), Intracardiac Echography (ICE), Thrombus, and Multiplanar Reconstruction (MPR), along with basic manual measurement tools for distance, perimeter, area, angle, signal intensity, and coordinates based on user-identified regions of interest. The software incorporates machine learning methodology to generate a 3D rendering of the left side of the heart (left ventricle, left atrium, and LAA) for visualization purposes only, without measurement capabilities in this view. TruPlan also provides reporting functionality, allowing users to capture screenshots and measurements in a PDF document. Performance data confirms that verification and validation activities, including the use of validated phantoms for quantitative measurement assessment, were conducted. Testing ensured compliance with various standards such as ISO 13485, IEC 62304, IEC 62366, ISO 14971, and NEMA DICOM conformance, as well as addressing cybersecurity management. The device is intended for adult patients and serves as an aid to the existing standard of care, not as a replacement for current planning software.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the accuracy of TruPlan's machine learning-based 3D rendering compare to manual segmentation or other automated segmentation algorithms for LAA visualization?; What is the inter-observer and intra-observer variability for the manual measurements performed using TruPlan's quantification tools, particularly for LAA landing zone dimensions?; How does the performance of TruPlan's simulated fluoroscopy, TEE, and ICE views correlate with actual intraprocedural imaging in terms of anatomical representation and guidance for LAAC?; What specific CT acquisition protocols are recommended or required to optimize image quality and ensure the accuracy of measurements and visualizations within TruPlan?; Beyond LAAC, are there plans to validate or expand TruPlan's capabilities for pre-procedural planning of other structural heart interventions?