Current validation practice undermines surgical AI development
q-bio.OT
/ Authors
Annika Reinke, Ziying O. Li, Minu D. Tizabi, Pascaline André, Marcel Knopp, Mika M. Rother, Ines P. Machado, Maria S. Altieri, Deepak Alapatt, Sophia Bano
and 88 more authors
Sebastian Bodenstedt, Oliver Burgert, Elvis C. S. Chen, Justin W. Collins, Olivier Colliot, Evangelia Christodoulou, Tobias Czempiel, Adrito Das, Reuben Docea, Daniel Donoho, Qi Dou, Jennifer Eckhoff, Sandy Engelhardt, Gabor Fichtinger, Philipp Fuernstahl, Pablo García Kilroy, Stamatia Giannarou, Stephen Gilbert, Ines Gockel, Patrick Godau, Jan Gödeke, Teodor P. Grantcharov
/ Abstract
Surgical data science (SDS) is rapidly advancing, yet clinical adoption of artificial intelligence (AI) in surgery remains limited, with inadequate validation emerging as an important contributing factor. In fact, existing validation practices often neglect the temporal and hierarchical structure of intraoperative videos, producing misleading, unstable, or clinically irrelevant results. In a pioneering, consensus-driven effort, we introduce a comprehensive catalog of validation pitfalls in AI-based surgical video analysis that was derived from a multi-stage Delphi process with 92 international experts. The collected pitfalls span three categories: (1) data (e.g., incomplete annotation, spurious correlations), (2) metric selection and configuration (e.g., neglect of temporal stability, mismatch with clinical needs), and (3) aggregation and reporting (e.g., clinically uninformative aggregation, failure to account for frame dependencies in hierarchical data structures). A systematic review of surgical AI papers reveals that these pitfalls are widespread in current practice, with the majority of studies failing to account for temporal dynamics or hierarchical data structure, or relying on clinically uninformative metrics. Experiments on real surgical video datasets provide empirical evidence that ignoring temporal and hierarchical data structures can substantially understate uncertainty, obscure critical failure modes, and even alter algorithm rankings. To address these shortcomings, we provide a catalogue of best practices compiled in a multi-stage Delphi process. Together, this work provides an evidence-based framework to inform more rigorous validation of surgical video analysis algorithms and to guide future efforts in benchmarking, reporting, regulatory review, and clinical translation.