LARALAB

LARALAB is a cloud-based software application that enables cardiologists, radiologists, and heart surgeons to import, visualize, assess, and measure cardiovascular structures from DICOM-compliant CT medical images. It is intended to aid preprocedural planning and sizing for cardiovascular interventions and surgery, as well as postprocedural image review. The software provides automatic segmentation and measurements using deep learning algorithms, along with manual measurement and visualization tools.

LARALAB is cloud-based with user authentication, data encryption (HTTPS/SSL), and encrypted storage, whereas the predicate device (3mensio Workstation) is a traditional local software installation. Both devices provide automatic segmentation of cardiovascular structures and manual measurement tools including length, spline/diameter, angle, and volume measurements. LARALAB uses deterministic deep learning algorithms to generate pre-calculated segmentations and measurements that users review and adjust; the predicate uses both automatic and manual steps. Both support MPR visualization and PDF reporting, though the predicate offers additional functionality for coronary artery assessment and additional 3D rendering options.

Not stated in this summary.

LARALAB is substantially equivalent to 3mensio Workstation because both devices share the same general intended use (preprocedural planning and postprocedural assessment of cardiovascular structures) and similar indications for use. The performance testing demonstrated that LARALAB's automatic segmentations achieved Dice scores of 0.89–0.98 for major cardiac structures and that Bland-Altman analysis showed measurements were within predefined acceptance criteria with ICC values above 0.75, matching the predicate device's performance. Although LARALAB uses cloud-based access and deep learning algorithms versus the predicate's local installation and combined automatic/manual approach, these differences do not raise new safety or effectiveness questions because both devices output identical measurement types that are user-reviewed before clinical use, and LARALAB's cybersecurity controls mitigate cloud-specific risks.