A prospective, nonrandomized clinical investigation of the da Vinci surgical system model IS5000

Since the initial clearance of the da Vinci Surgical System, there have been multiple design evolutions. The da Vinci Surgical System Model IS5000 (da Vinci 5) is a modification to the predicate da Vinci Xi Surgical System with the same core features and significant enhancements to system electronics, Surgeon Surgical Console, integrated electrosurgical generator and carbon dioxide insufflator, and Force Feedback surgical instruments. To confirm the safety, effectiveness, and usability of the da Vinci 5 in performing robotic-assisted surgical procedures. This study is a nonrandomized, prospective clinical trial. Subjects scheduled to undergo robotically assisted surgical procedures in one of four surgical specialties were enrolled in this IRB approved Investigational Device Exemption (IDE) study from December 2022 through May 2023. The primary effectiveness endpoint was the ability to complete the procedure without conversion to open. The primary safety endpoint was the incidence of adverse events through 30 days. Usability was assessed with observational data collected by Human Factors assessment during actual use across various surgeon experiences. Data were collected from 53 subjects across four United States clinical sites who underwent one of eight procedures using the da Vinci 5 robotic system. There were no intraoperative conversions to open, and no device-related adverse events or unanticipated adverse device effects reported through 30 days. The da Vinci 5 demonstrated excellent usability by Human Factors assessment. The study confirms that the da Vinci 5 surgical system is safe, effective, and usable, and does not pose new risks. The Human Factors data further confirmed the safety, effectiveness, and ease of use of the system. Trial Registration: This study is registered on Clinicaltrials.gov. Trial ID is NCT05682742.