Artificial intelligence in endoscopic ultrasound: Clinical translation of a prediction, navigation, and diagnosis framework

Table 3 Phased clinical integration roadmap

Phase	Primary goals	Key evidence required	Regulatory milestones
Phase 1 (1-2 years)	Low-risk auxiliary tasks (e.g., automated measurement, structured reporting)	Feasibility studies, human-machine interaction safety data	Registration or simplified clearance (e.g., class II medical device)
Phase 2 (3-5 years)	Moderate-risk diagnostic support (e.g., lesion detection and classification)	Multicenter diagnostic accuracy studies, clinical utility assessment	Moderate-risk device approval (requires performance monitoring plan)
Phase 3 (> 5 years)	High-risk autonomous functions (e.g., puncture path planning, real-time complication alert)	Large-scale RCTs: Real-world effectiveness data	High-risk device approval (requires a full post-market surveillance system)

This table outlines a risk-escalating, phased pathway for integrating artificial intelligence into endoscopic ultrasound practice. Each phase defines primary objectives, key study designs for validation, and corresponding regulatory milestones, supporting a systematic and evidence-based approach to clinical implementation. RCT: Randomized controlled trial.