NMPA PTR Analysis: Performance Indicators and Inspection Method for Spine Navigation Systems

Some of you may be familiar with the NMPA PTR, which consists of five parts. The most crucial components are the performance indicators and inspection method, which can be quantified or objectively described. To determine the performance indicators, we will search for resources such as IFU (Fiagon and Intracs), PTR (Fiagon), Design input (Intracs), FDA 510K summary, and NMPA review reports of similar products. We reviewed the Fiagon 510K summary and discovered that it only pertains to ENT surgery and not spine surgery. We are uncertain if we can acquire the IFU and PTR of Fiagon unofficially via the doctor's channel, but we discovered that a hospital in Guangzhou purchased the Fiagon spine navigation system through literature. If possible, obtaining the IFU would be ideal. We examined nine NMPA review reports of navigation systems, and only one pertained to electrical-magnetic location. We can use its performance testing as a reference.