Accuracy in planar cutting of bones: an ISO-based evaluation

Area of Science:

• Orthopaedic surgery
• Surgical technology
• Medical device evaluation

Background:

• Computer- and robot-assisted technologies enhance precision in orthopaedic planar bone cutting.
• Current evaluation methods for surgical cutting accuracy require further development.
• This study introduces a novel evaluation methodology based on International Organization for Standardization (ISO) standards.

Purpose of the Study:

• To formulate and validate a new evaluation methodology for planar bone cutting in orthopaedic surgery.
• To assess the accuracy of surgical cuts under different assistance levels.
• To establish a standardized approach for comparing surgical assistance technologies.

Main Methods:

• A geometrical model of the bone cutting process was utilized.
• Cuts were performed with three levels of surgical assistance: unassisted, computer-assisted, and robot-assisted.
• Key ISO 1101:2004 parameters including flatness, parallelism, and location of the cut plane were measured.

Main Results:

• The location parameter proved most critical for evaluating cutting errors.
• Distinct differences in cutting accuracy were observed across the three assistance levels.
• The location parameter effectively differentiated between unassisted, computer-assisted, and robot-assisted procedures.

Conclusions:

• The proposed ISO methodology effectively utilizes the location parameter to capture translational and rotational cutting errors.
• This approach provides comprehensive data for assessing surgical accuracy.
• The methodology is applicable to any osseous structure for comparing the performance of surgical assistance technologies.