To evaluate the adoption of Predetermined Change Control Plans (PCCPs) among FDA-cleared radiology AI/ML devices and assess the transparency of public documentation.
Approach:
Study Design: A systematic scoping review was conducted following PRISMA guidelines, registered in PROSPERO, evaluating FDA-cleared radiology AI/ML devices from 2015 to 2025.
Data Sources: FDA 510(k), de novo, premarket approval, and breakthrough device databases were accessed on April 1, 2026, with manual verification of PCCP devices against regulatory summaries.
Assessment Method: PCCP documentation was evaluated using an 8-point rubric covering specificity, data and validation transparency, real-world evaluation, and postmarket monitoring.
Key Findings:
Out of 1,394 FDA-listed AI/ML submissions, 1,080 (78%) were in radiology, with 1,068 (99%) cleared through the 510(k) pathway.
Among 870 unique radiology devices, 130 (15%) underwent sequential 510(k) clearances for significant modifications.
The mean interval between sequential submissions decreased from 25 months prior to 2021 to 13 months post-2021.
Of 37 radiology devices cleared with PCCPs, 34 (92%) were AI/ML devices, with 22 cleared in 2025.
Public documentation had a mean score of 5 on the 8-point rubric, with only 3 devices describing postmarket surveillance.
Mean documentation scores increased from 4 in 2024 to 5 in 2025.
Interpretation:
The analysis indicates an increase in the adoption of PCCPs among radiology AI devices, but public documentation often lacks comprehensive details on postmarket performance monitoring.
Limitations:
Analysis limited by publicly available data, with internal safety assessments and minor software changes inaccessible.
Database inconsistencies and challenges in deduplicating devices due to corporate rebranding.
The transparency rubric used was not designed as a comprehensive quality evaluation.
The recency of final FDA guidance may limit the analysis.
Conclusion:
The study highlights the need for improved transparency in public documentation regarding postmarket monitoring of radiology AI devices.
Operative-time–adjusted findings favored the ipsilateral technique, while absolute fluoroscopy time and radiation exposure remained similar between approaches.
Investigators examined Life’s Essential 8 scores and carotid ultrasonography measures across cardiovascular-kidney-metabolic stages in 1,283 young adults.
