Device-Specific Cut-Offs of Canon Aplio i800 2D Shear Wave Elastography for Advanced Fibrosis in MASLD: A Histologically Validated Study.

PURPOSE: To evaluate the diagnostic accuracy of Canon Aplio i800 two-dimensional shear wave elastography (2D-SWE) for detecting advanced fibrosis (≥ F3) in metabolically associated steatotic liver disease (MASLD) using histology as reference, and to compare its performance with the FIB-4 index. MATERIALS AND METHODS: In this prospective single-center study, 49 patients with MASLD and available liver histology were included. Fibrosis staging (F0-F4) was assessed by three blinded pathologists according to Brown and Kleiner. Shear wave velocity (m/s) served as the primary elastography parameter. Diagnostic performance for ≥ F3 was assessed by ROC analysis, and clinically applicable rule-in and rule-out thresholds were determined using predefined sensitivity- and specificity-based criteria. RESULTS: Advanced fibrosis (≥ F3) was present in 15/49 patients (30.6%). 2D-SWE demonstrated an AUROC of 0.88 (95% CI 0.78-0.96) for ≥ F3, compared with 0.84 (95% CI 0.71-0.96) for FIB-4 (p = 0.39). A threshold of 1.45 m/s (6.3 kPa) achieved 100% sensitivity and negative predictive value. A threshold of 1.85 m/s (11.0 kPa) yielded 94% specificity and 82% positive predictive value. CONCLUSION: Canon Aplio i800 2D-SWE provides robust and clinically applicable, device-specific non-invasive detection of advanced fibrosis in MASLD and supports implementation into guideline-based stepwise risk stratification.