Regulatory and Compliance

Quality

AI Sight’s Quality Management System has been independently audited to be compliant with ISO 13485: 2016

AI Sight’s Assisted Grading Tool is approved for sale in the UK as a Class I medical device

The AI Sight system is approved for sale in the EU and UK as a Class IIa medical device

BSI 0086

AI Sight Limited

Innovation Centre

Keckwick Lane

Daresbury

WA4 4FS

Version: 1.0

Release Date: 01/05/2025

Class IIa Medical Device

Blum Technology Group

18-22 Hamilton Street

Birkenhead

CH41 1AL

Intended Use: This device is intended to grade the severity of diabetic retinopathy in fundus photographs

The device is intended to operate with >80% sensitivity and >90% specificity in line with existing guidelines for diabetic retinopathy screening

There are no contraindications associated with the use of the software, however:

Images that are blurred or have low resolution may not be suitable for analysis
AI Sight is specifically designed for diabetic retinopathy; other retinal conditions may not be accurately assessed
The system’s algorithms may not be calibrated for children’s retinal images
Patients with advanced ocular conditions that significantly alter retinal appearance may not be suitable for AI Sight analysis
Patients who have recently undergone eye surgery may need to wait until full recovery before use of AI Sight

In the event of a serious incident please contact the manufacturer: team@ai-sight.co.uk

You may also consider contacting the competent authority in the UK to report the incident: MHRA tel 02030 806000 or info@mhra.gov.uk

In the EU, the manufacturer will inform EUDAMED on receipt of your report of a serious incident

For version 1.0 release date 01/05/25:

System Requirements Hardware Requirements (for End-Users)

Processor: Minimum: Any modern dual-core processor (e.g., Intel Core 2 Duo, AMD Athlon X2, or newer processors from the last 8-10 years). Recommended: Intel Core i3 (4th generation or newer) or AMD Ryzen 3 (1st generation or newer) or equivalent. •
RAM: Minimum: 4GB. Recommended: 8GB or more
Display Resolution: Minimum: 1024x768. Recommended: 1280x720 or higher (responsive design should adapt to various resolutions).

Software Requirements (for End-Users)

Supported Operating Systems: Windows 10 (Version 22H2 or later), Windows 11 (any version), macOS Monterey (12.x) or later, Linux (any modern distribution with a compatible browser, e.g., Ubuntu 20.04 LTS or later, Fedora 38 or later)
Supported Browsers: Google Chrome: Version 114 or later (released mid-2023) 8 02/06/2025, 08:20. Mozilla Firefox: Version 115 (ESR) or later, or regular release version 120 or later (released late 2023). Apple Safari: Version 16.0 or later (released late 2022. Microsoft Edge: Version 114 or later (Chromium-based, released mid-2023)

Network Requirements (for End-Users)

Minimum and Recommended Internet Connection Speed: Minimum: A stable connection of 1-2 Mbps download might work for basic functionality, but real time updates will benefit from more. Recommended: 5 Mbps download/upload or higher for a smooth experience, especially with frequent real-time data exchange

Please click below for instructions for use