PurposeThe purpose of this study was to evaluate the diagnostic accuracy of artificial intelligence (AI) models with magnetic resonance imaging(MRI) in predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy (nCRT) in patients with rectal cancer. Furthermore, assessed the methodological quality of the models.MethodsWe searched PubMed, Embase, Cochrane Library, and Web of science for studies published before 21 June 2022, without any language restrictions. The Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) and Radiomics Quality Score (RQS) tools were used to assess the methodological quality of the included studies. We calculated pooled sensitivity and specificity using random-effects models, I2 values were used to measure heterogeneity, and subgroup analyses to explore potential sources of heterogeneity.ResultsWe selected 21 papers for inclusion in the meta-analysis from 1562 retrieved publications, with a total of 1873 people in the validation groups. The meta-analysis showed that AI models based on MRI predicted pCR to nCRT in patients with rectal cancer: a pooled area under the curve (AUC) 0.91 (95% CI, 0.88-0.93), sensitivity of 0.82(95% CI,0.71-0.90), pooled specificity 0.86(95% CI,0.80-0.91). In the subgroup analysis, the pooled AUC of the deep learning(DL) model was 0.97, the pooled AUC of the radiomics model was 0.85; the pooled AUC of the combined model with clinical factors was 0.92, and the pooled AUC of the radiomics model alone was 0.87. The mean RQS score of the included studies was 10.95, accounting for 30.4% of the total score.ConclusionsRadiomics is a promising noninvasive method with high value in predicting pathological response to nCRT in patients with rectal cancer. DL models have higher predictive accuracy than radiomics models, and combined models incorporating clinical factors have higher diagnostic accuracy than radiomics models alone. In the future, prospective, large-scale, multicenter investigations using radiomics approaches will strengthen the diagnostic power of pCR.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42021285630.