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Evidence Review
Copyright: ©Author(s) 2026.
Artif Intell Gastrointest Endosc. Sep 8, 2026; 7(2): 121109
Published online Sep 8, 2026. doi: 10.37126/aige.121109
Table 2 Prospective checklist for advancing an endoscopic artificial intelligence system to the next tier
Question
Why it matters
Minimum evidence before advancing tier
Does the system improve a clinically meaningful endpoint rather than only image-level accuracyDetection gains may not translate into patient benefit if they mainly increase low-value findingsAt least one prospective study with workflow-relevant outcomes; tier 1 requires multicenter randomized or pooled randomized evidence
Is there a clear action pathway once the AI output is generatedOutputs without downstream decisions create ambiguity, delay, and liability riskExplicit linkage between AI output and biopsy, resection, documentation, referral, or review pathway
Has performance been shown outside the development environmentSingle-center or single-vendor success often overestimates real-world performanceExternal validation across centres, operators, and ideally more than one hardware ecosystem
Will deployment preserve safe human performanceAutomation bias and deskilling can offset technical gainsHuman-factors plan with onboarding, override logging, periodic AI-off benchmarking, and monitoring of behaviour-level metrics
Is governance defined before launchUndefined responsibility undermines adoption and patient safetyNamed accountability, update policy, discordant-case review, and AI-specific protocol or reporting aligned with CONSORT-AI or DECIDE-AI when applicable
Is post-deployment monitoring specifiedStatic pre-deployment evidence cannot detect drift, latency issues, or workflow changesNamed metrics, review frequency, trigger thresholds, rollback or recalibration plan, and change-control policy consistent with lifecycle guidance
Is the dataset and validation geography sufficiently representativeGeographic and demographic concentration limits generalizability and equityEvidence of representation across populations, settings, and device environments relevant to intended deployment
Is the system economically and operationally sustainableClinical value may be offset by cost, follow-up burden, or proprietary infrastructure constraintsContext-specific implementation plan addressing costs, maintenance, reimbursement, and downstream utilization


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