Objective:This systematic review aims to examine the use of standard-setting methods in the context of simulation-based training of surgical procedures.Summary of background:Simulation-based training is increasingly used in surgical education. However, it is important to determine which level of competency trainees must reach during simulation-based training before operating on patients. Therefore, pass/fail standards must be established using systematic, transparent, and valid methods.Methods:Systematic literature search was done in 4 databases (Ovid MEDLINE, Embase, Web of Science, and Cochrane Library). Original studies investigating simulation-based assessment of surgical procedures with the application of a standard setting were included. Quality of evidence was appraised using GRADE.Results:Of 24,299 studies identified by searches, 232 studies met the inclusion criteria. Publications using already established standard settings were excluded (N = 70), resulting in 162 original studies included in the final analyses. Most studies described how the standard setting was determined (N = 147, 91%) and most used the mean or median performance score of experienced surgeons (n = 65, 40%) for standard setting. We found considerable differences across most of the studies regarding study design, setup, and expert level classification. The studies were appraised as having low and moderate evidence.Conclusion:Surgical education is shifting toward competency-based education, and simulation-based training is increasingly used for acquiring skills and assessment. Most studies consider and describe how standard settings are established using more or less structured methods but for current and future educational programs, a critical approach is needed so that the learners receive a fair, valid, and reliable assessment.