Source record
Autonomous diabetic retinopathy screening in primary care
Текст показан по-английски, пока нет перевода.
The source is the U.S. FDA De Novo decision DEN180001 for IDx-DR, now marketed as LumineticsCore, dated 11 April 2018. It authorizes autonomous screening of adults with diabetes for more-than-mild diabetic retinopathy, using a specified retinal camera, without a clinician reading the image first. FDA’s review describes a study of 900 patients at 10 primary care sites, with sensitivity 87.4% and specificity 89.5% for more-than-mild diabetic retinopathy. The decision is a device authorization, not a claim that the software replaces a full eye examination.
- Source date
- 11 апр. 2018 г. · Год 2018
- Evidence label
- Регуляторное
- Source type
- Новость
Citation
U.S. FDA De Novo DEN180001
U.S. Food and Drug Administration. De Novo classification request DEN180001, IDx-DR (marketed as LumineticsCore by Digital Diagnostics). Decision date 11 April 2018. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180001
Key public facts
- FDA authorized the system on 11 April 2018 to screen adults with diabetes for more-than-mild diabetic retinopathy without an eye specialist reading the photograph first.
- The pathway uses a specified retinal camera. This index names the Topcon NW400 among the configurations associated with the product.
- The output is a refer-or-rescreen result. It is not a complete eye examination.
- Pregnancy and several existing retinal conditions sit outside the labeled use.
- In the study FDA reviewed, 900 patients were enrolled at 10 primary care sites. Sensitivity for more-than-mild diabetic retinopathy was 87.4%, and specificity was 89.5%.
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