Prima v1.0

PRIMA is a radiation-free 3D scanning device designed to quantitatively monitor Hand Osteoarthritis (OA) progression in clinical settings. The scanner is composed of cameras attached to a semi-circular ring which acquires pictures of a finger from different angles, combined with LED strip lighting for uniform illumination. Using edge detection algorithms, the system generates a 3D reconstruction of individual hands/fingers, enabling clinicians to track morphological changes such as Heberden's and Bouchard's nodes over time.

AI-Integrated Features: PRIMA is designed as an AI-ready platform with integrated capabilities for advanced diagnostics:

• Predictive Analytics: The system is architected to support machine learning algorithms for automated disease progression forecasting based on longitudinal 3D scan data

• Automated Reporting: AI-powered analysis can generate objective diagnostic reports, reducing interpretation variability between clinicians

• Cloud Storage & AI Analytics Subscription: Optional cloud-based service enabling secure patient data storage, cross-institutional comparison, and continuous model improvement through incremental machine learning

• The software architecture follows IMDRF guidelines for Machine Learning Software (Incremental)—software that continuously uses input data to extend its knowledge after market release

Key Technical Specifications:

• Scan time: 10.3 ± 0.7 seconds per hand/finger

• Repeatability: coefficient of variation < 1.3%

Clinical Value: Unlike current X-ray imaging methods that expose patients to harmful radiation and require specialist clinicians, PRIMA offers a safe, non-invasive alternative suitable for use by general practitioners in clinics and GP studios. The device outputs key physiological parameters—including DIP joint-to-phalanx diameter ratios and phalangeal deviation angles—providing objective, quantitative data to support diagnosis and treatment planning for the 8.75 million people over 45 who have sought treatment for OA.