Monaco RTP System (6.3)

The Monaco RTP System (6.3) is a radiation treatment planning system that accepts patient imaging data from CT and MR scans and creates treatment plans for external beam radiation therapy. It calculates radiation dose distributions for photon, electron, and proton treatments, displays doses in 2D or 3D format, and supports planning methods including IMRT, VMAT, stereotactic planning, and adaptive therapy.

Monaco 6.3 introduces three main new features: an AI-based segmentation component for automatic MR image segmentation, an auto-planning feature for iterative optimization, and extended adaptive planning capabilities to conventional linacs (EMLA) in addition to MR-linacs. The GPU-accelerated optimizer uses a Pseudo-Gradient Descent algorithm. Interoperability with third-party contouring software was added, and non-UI based scripting is now supported alongside UI-based scripting.

ISO 13485, ISO 14971, IEC 62304, IEC 62083, IEC 82304-1, IEC 61217, IEC 62366-1, IEC 81001-5-1, ISO 15223-1, ISO 20417. Testing used Average Hausdorff Distance (AVD) with 3mm threshold for segmentation validation and DICE/AUC metrics.

Monaco 6.3 has identical intended use and indications as predicate Monaco 6.2 (K223233) with unchanged principles of operation. Non-clinical verification and validation testing demonstrated all new features meet predefined acceptance criteria and do not introduce new safety or effectiveness concerns. The device conforms to applicable safety standards and performs comparably to the predicate device.