Maestro System (REF100)

The Maestro System is a robotic surgical assistance device with two motorized arms that hold and position laparoscopes and laparoscopic instruments during minimally invasive surgery. Motors compensate for gravitational force on instruments while the surgeon retains full manual control; once the surgeon releases the instrument, the system maintains its position.

The subject device adds 5G and WiFi connectivity for cloud-based data offload of telemetry and event logs, updates the Linux operating system from Yocto v0.5.1 to v1.0.0, reduces system weight from 322 kg to 290 kg, and implements a PCCP for the ScoPilot machine-learning feature that detects and tracks surgical instruments in video. All other hardware, mechanical, and control characteristics remain identical to the predicate.

IEC 60601-1:2005+A1+A2 and IEC 60601-1-6:2010+A1+A2 for electrical safety; IEC 60601-1-2:2014+A1 for EMC; AIM 7351731 Rev. 3.00:2020 for electromagnetic immunity; IEEE/ANSI C63.27:2021 for wireless coexistence. Software testing followed FDA guidance on device software functions and cybersecurity.

The intended use and indications for use are identical to the predicate. The connectivity modifications (5G/WiFi) affect only data offload and do not alter the core function of holding and positioning instruments or the surgeon's control pathway. The ScoPilot feature is managed via an FDA-cleared PCCP with equivalent performance validation requirements. Design verification testing confirmed all safety functions (single fault tolerance, emergency stop, hold position accuracy, electro-cautery compatibility) remain unchanged. The OS update contains no user-facing changes and maintains the same QNX 7.1.0 kernel. System weight reduction is an ease-of-use improvement with no impact on safety or effectiveness.