Performance assessment of surgical tracking systems based on statistical process control and longitudinal QA

Area of Science:

• Medical device performance assessment
• Surgical navigation technology
• Quality assurance in healthcare

Background:

• Surgical trackers are crucial for accurate instrument positioning during procedures.
• Existing performance assessment methods may not support routine, longitudinal testing.
• Ensuring consistent accuracy and reliability of surgical trackers is paramount for patient safety.

Purpose of the Study:

• To report a novel system for the performance assessment and quality assurance (QA) of surgical trackers.
• To implement routine longitudinal testing using geometric accuracy and statistical process control (SPC).
• To establish a rapid QA process (<1 minute) for surgical tracker systems.

Main Methods:

• Designed a simple QA test phantom with registration fiducials based on analytical models for target registration error (TRE).
• Configured a tracker testbed with open-source software to measure TRE-based accuracy and Jitter.
• Conducted Phase I SPC analysis to establish system control limits and Phase II weekly QA for up to 32 weeks.

Main Results:

• Established control limits for six tested NDI trackers (2 EM, 4 IR).
• Electromagnetic (EM) trackers showed higher control limits for accuracy and Jitter compared to infrared (IR) trackers.
• Older trackers, like the Vicra, exhibited evidence of performance degradation (e.g., increased Jitter, p < .05).

Conclusions:

• The developed system enables efficient (<1 minute) and routine longitudinal QA for surgical trackers.
• The process successfully identified tracker performance variations and potential degradation over time.
• Intervention resolved most failures, highlighting the system's utility in maintaining surgical navigation accuracy.