AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices

Ariel Yuhan Ong   ^{1, 2} , MBChB ;   Henry David Jeffry Hogg   ^{1, 3} , MBBS, MRes ;   Aditya U Kale   ^{4, 5} , MBChB ;   Priyal Taribagil   ¹ , MBBS ;   Ashley Kras   ⁶ , MD ;   Eliot Dow   ⁷ , MD, PhD ;   Trystan Macdonald   ^{4, 5, 8} , MBChB ;   Xiaoxuan Liu   ^{4, 5, 8, 9} , PhD ;   Pearse A Keane   ^{1, 10, 11} , MD ;   Alastair K Denniston   ^{4, 5, 8, 9} , PhD

¹ Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom

² Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom

³ Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle, United Kingdom

⁴ Department of Ophthalmology, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom

⁵ Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom

⁶ Sydney Eye Hospital, Sydney, Australia

⁷ Retinal Consultants Medical Group, Sacramento, CA, United States

⁸ NIHR Birmingham Biomedical Research Centre, Birmingham, United Kingdom

⁹ Centre for Regulatory Science and Innovation, Birmingham Health Partners, Birmingham, United Kingdom

¹⁰ Institute of Ophthalmology, University College London, London, United Kingdom

¹¹ NIHR Moorfields Biomedical Research Centre, London, United Kingdom