Artificial intelligence as a medical device for ophthalmic imaging in Europe, Australia, and the United States: protocol for a systematic scoping review of regulated devices (Preprint)

BACKGROUND Artificial intelligence as a medical device (AIaMD) has the potential to transform many aspects of ophthalmic care, such as improving accuracy and speed of diagnosis, addressing capacity issues in high volume areas such as screening, and detecting novel biomarkers of systemic disease in the eye (oculomics). In order to ensure that such tools are safe for the target population and achieve their intended purpose, it is important that these AIaMD have adequate clinical evaluation to support any regulatory decision. Currently, the evidential requirements for regulatory approval are less clear for AIaMD compared to more established interventions such as drugs or medical devices. There is therefore value in understanding the level of evidence that underpins AIaMD currently on the market, as a step towards identifying what best practice might be in this area. In this systematic scoping review, we will focus on AIaMD that contribute to clinical decision making (relating to screening, diagnosis, prognosis, treatment) in the context of ophthalmic imaging. OBJECTIVE To identify regulator-approved AIaMD for ophthalmic imaging in Europe, Australia, and the US; report the characteristics of these devices and their regulatory approvals; and report the available evidence underpinning these AIaMD. METHODS FDA (USA), ARTG (Australia), MHRA (UK) and EUDAMED (EU) regulatory databases will be searched for ophthalmic imaging AIaMD via a snowballing approach. PubMed and clinical trial registries will be systematically searched, and manufacturers will be directly contacted for studies investigating the effectiveness of eligible AIaMD. Preliminary regulatory database searches, evidence searches, screening, and data extraction, and methodological quality assessment will be undertaken by two independent review authors and arbitrated by a third at each stage of the process. RESULTS Preliminary searches were conducted in February 2023, and screening is underway. Data extraction, data synthesis, and assessment of methodological quality will commence in June 2023. The review is on track to be completed and submitted for peer review by December 2023. CONCLUSIONS This systematic review will provide greater clarity on ophthalmic imaging AIaMD that have achieved regulatory approval as well as the evidence that underpins them. This should help adopters to understand the range of tools available and whether they can be safely incorporated into their clinical workflow, and support developers in navigating regulatory approval more efficiently.