fig1

Figure 1. Levels of Risk for New Devices in Canada (levels I-IV) , the European Union (levels I-IV) and the United States of America (levels I-III). Proposed level 5 in white (would be 4 in the United States of America) for devices with level 4 or 5 of surgical autonomy; and proposed level 0 in white for devices with level 2 or 3 of surgical autonomy to incentivize the development of more intelligent surgical/endoscopic and interventional devices.