ARTICOR planner

ARTICOR planner is a software system for planning structural heart and vascular procedures. It processes DICOM-compliant medical images to create 3D anatomical models, perform measurements, and simulate device placement and fluoroscopic angles. The software runs on a desktop PC and can also operate on an augmented reality head-mounted display (Microsoft HoloLens 2) to enable immersive treatment planning.

ARTICOR planner includes a desktop software component plus an optional augmented reality (AR) interface via head-mounted display, whereas the predicate device (Materialise Mimics Enlight) runs only on a PC. Both support DICOM image import, 3D segmentation, measurement tools, and fluoroscopic angle planning. The subject device workflow is not guided, while the predicate uses a guided workflow structure. The subject device adds remote collaboration capability and AR-based measurements; the predicate can generate output files for physical replica fabrication.

IEC 62304 (medical device software lifecycle), IEC 62366 (usability engineering), IEC 63145 (head-mounted display optical performance), IDMS standards, ISO/IEC 17025 accreditation, and FDA guidance documents on device software content, technical performance assessment of quantitative imaging, and human factors engineering.

ARTICOR planner is substantially equivalent to Materialise Mimics Enlight because both devices share the same intended use (aiding planning of structural heart and vascular procedures via DICOM image analysis, 3D modeling, and measurement), serve identical user profiles and patient populations, and provide equivalent core functionality for anatomical analysis and procedure planning. Technological differences (AR interface, lack of guided workflow, remote collaboration) do not raise new safety or efficacy concerns because usability and measurement accuracy were validated through bench testing, and other cleared devices already incorporate similar AR and collaborative features.