AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices
BackgroundArtificial 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 o...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2024-03-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2024/1/e52602 |
| _version_ | 1797262386981240832 |
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| author | Ariel Yuhan Ong Henry David Jeffry Hogg Aditya U Kale Priyal Taribagil Ashley Kras Eliot Dow Trystan Macdonald Xiaoxuan Liu Pearse A Keane Alastair K Denniston |
| author_facet | Ariel Yuhan Ong Henry David Jeffry Hogg Aditya U Kale Priyal Taribagil Ashley Kras Eliot Dow Trystan Macdonald Xiaoxuan Liu Pearse A Keane Alastair K Denniston |
| author_sort | Ariel Yuhan Ong |
| collection | DOAJ |
| description |
BackgroundArtificial 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 toward identifying what the best practices might be in this area. In this systematic scoping review, we will focus on AIaMD that contributes to clinical decision-making (relating to screening, diagnosis, prognosis, and treatment) in the context of ophthalmic imaging.
ObjectiveThis study aims to identify regulator-approved AIaMD for ophthalmic imaging in Europe, Australia, and the United States; report the characteristics of these devices and their regulatory approvals; and report the available evidence underpinning these AIaMD.
MethodsThe Food and Drug Administration (United States), the Australian Register of Therapeutic Goods (Australia), the Medicines and Healthcare products Regulatory Agency (United Kingdom), and the European Database on Medical Devices (European Union) regulatory databases will be searched for ophthalmic imaging AIaMD through 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, data extraction, and methodological quality assessment will be undertaken by 2 independent review authors and arbitrated by a third at each stage of the process.
ResultsPreliminary searches were conducted in February 2023. Data extraction, data synthesis, and assessment of methodological quality commenced in October 2023. The review is on track to be completed and submitted for peer review by April 2024.
ConclusionsThis 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 understand the range of tools available and whether they can be safely incorporated into their clinical workflow, and it should also support developers in navigating regulatory approval more efficiently.
International Registered Report Identifier (IRRID)DERR1-10.2196/52602 |
| first_indexed | 2024-04-24T23:56:18Z |
| format | Article |
| id | doaj.art-973b14aee6ba40afb78e4fa710b43f62 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-04-24T23:56:18Z |
| publishDate | 2024-03-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-973b14aee6ba40afb78e4fa710b43f622024-03-14T12:30:31ZengJMIR PublicationsJMIR Research Protocols1929-07482024-03-0113e5260210.2196/52602AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated DevicesAriel Yuhan Onghttps://orcid.org/0000-0001-9300-573XHenry David Jeffry Hogghttps://orcid.org/0000-0001-8044-7790Aditya U Kalehttps://orcid.org/0000-0002-2186-1446Priyal Taribagilhttps://orcid.org/0000-0002-6516-3615Ashley Krashttps://orcid.org/0000-0003-1160-104XEliot Dowhttps://orcid.org/0000-0001-7409-2049Trystan Macdonaldhttps://orcid.org/0000-0002-8561-0718Xiaoxuan Liuhttps://orcid.org/0000-0002-1286-0038Pearse A Keanehttps://orcid.org/0000-0002-9239-745XAlastair K Dennistonhttps://orcid.org/0000-0001-7849-0087 BackgroundArtificial 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 toward identifying what the best practices might be in this area. In this systematic scoping review, we will focus on AIaMD that contributes to clinical decision-making (relating to screening, diagnosis, prognosis, and treatment) in the context of ophthalmic imaging. ObjectiveThis study aims to identify regulator-approved AIaMD for ophthalmic imaging in Europe, Australia, and the United States; report the characteristics of these devices and their regulatory approvals; and report the available evidence underpinning these AIaMD. MethodsThe Food and Drug Administration (United States), the Australian Register of Therapeutic Goods (Australia), the Medicines and Healthcare products Regulatory Agency (United Kingdom), and the European Database on Medical Devices (European Union) regulatory databases will be searched for ophthalmic imaging AIaMD through 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, data extraction, and methodological quality assessment will be undertaken by 2 independent review authors and arbitrated by a third at each stage of the process. ResultsPreliminary searches were conducted in February 2023. Data extraction, data synthesis, and assessment of methodological quality commenced in October 2023. The review is on track to be completed and submitted for peer review by April 2024. ConclusionsThis 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 understand the range of tools available and whether they can be safely incorporated into their clinical workflow, and it should also support developers in navigating regulatory approval more efficiently. International Registered Report Identifier (IRRID)DERR1-10.2196/52602https://www.researchprotocols.org/2024/1/e52602 |
| spellingShingle | Ariel Yuhan Ong Henry David Jeffry Hogg Aditya U Kale Priyal Taribagil Ashley Kras Eliot Dow Trystan Macdonald Xiaoxuan Liu Pearse A Keane Alastair K Denniston AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices JMIR Research Protocols |
| title | AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices |
| title_full | AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices |
| title_fullStr | AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices |
| title_full_unstemmed | AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices |
| title_short | AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices |
| title_sort | ai as a medical device for ophthalmic imaging in europe australia and the united states protocol for a systematic scoping review of regulated devices |
| url | https://www.researchprotocols.org/2024/1/e52602 |
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