Maestro System (REF100)

The Maestro System is a motorized two-arm surgical support device that holds and positions laparoscopes and laparoscopic instruments during minimally invasive surgery. It includes a new ScoPilot feature that allows the laparoscope to automatically follow a selected instrument tip while the surgeon maintains control, helping preserve surgical flow and focus.

The device uses electro-mechanical jointed arms driven by internal motors with redundant encoders, mechanical instrument coupling, and a control algorithm applying motor current triggered by direct physician movement. The new ScoPilot feature employs machine learning-based image processing algorithms to detect and track surgical tool tips in video, calculate transformation matrices for laparoscope movement, and generate motion trajectories with safety limits.

Not stated in this summary. The document references FDA guidance documents on device software and cybersecurity but does not cite specific ISO, IEC, or ASTM consensus standards.

The Maestro System is substantially equivalent because it maintains the same intended use (holding and positioning laparoscopic instruments), uses identical mechanical components and coupling methods as the predicate, applies the same motor control algorithm triggered by physician force, and implements comparable image processing and tool detection functionality. The ScoPilot feature uses machine learning rather than computer vision for tool identification, but both approaches serve the identical function of enabling instrument-based laparoscope control—a capability already present in the predicate devices.