Accuracy of computer-aided techniques in orthopaedic surgery: How can it be defined, measured experimentally, and analyzed from a clinical perspective?

Surgical accuracy is multifactorial. Therefore, it is crucial to consider all influencing factors when investigating the accuracy of a surgical procedure, such as the surgeon's experience, the assistive technologies that may be used by the surgeon, and the patient factors associated with the specific anatomical site. For in vitro preclinical investigations, accuracy should be linked to the concepts of trueness (e.g., distance from the surgical target) and precision (e.g., variability in relation to the surgical target) to gather preclinical, quantitative, objective data on the accuracy of completed surgical procedures that have been performed with assistive technologies. The clinical relevance of improvements in accuracy that have been observed experimentally may be evaluated by analyzing the impact on the risk of failure and by taking into account the level of tolerance in relation to the surgical target (e.g., the extent of the safety zone). The International Organization for Standardization (ISO) methodology enables preclinical testing of new assistive technologies to quantify improvements in accuracy and assess the benefits in terms of reducing the risk of failure and achieving surgical targets with tighter tolerances before the testing of clinical outcomes.