PCCP Adoption and Transparency in FDA-Cleared Radiology AI Devices

A cross-sectional review assessed PCCP adoption and documentation completeness in FDA-cleared radiology AI/ML devices, using an 8-point rubric with high inter-rater reliability (ICC 0.93).

• Documentation completeness was scored by two independent observers using an 8-point rubric derived from FDA guidance.
• Interobserver agreement was excellent (intraclass correlation coefficient 0.93).

Automated summary

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