Table 1:

Summary of levels of evidence

Levels of Evidence	Element	Types of Evidence
Level 1	Clinical efficacy	One prospective or randomized clinical trial or meta-analysis
Level 2	Bias and error mitigation	At least 2 independent retrospective studies separate from original institution
Level 3	Reproducibility and generalizability	At least 2 retrospective studies with at least 1 from an institution independent of the original institution
Level 4	Technical efficacy	Two retrospective studies from the same institution
Level 5A	Data quality and AI model development with external testing	One retrospective study with internal and external data used for final performance reporting
Level 5B	Data quality and AI model development with internal testing	One retrospective study with only internal data used for final performance reporting
Level 6	Interoperability and integration into the IT infrastructure	AI company can provide a plan including interoperability standards for integration into the existing radiology and hospital digital information systems
Level 7	Legal and regulatory frameworks	AI-enabled tool is compliant with current patient data protection, security, privacy, HIPAA, and government regulations