Clinical grade development of an Ai system for diagnosis and Gleason grading of prostate cancer.

Purpose and goal: ** Denna text är maskinöversatt **

The goal of the project is to complete a commercial prototype of an AI platform that acts as decision support for pathologists regarding diagnosis and Gleason grading for digitized tissue sections from prostate cancer. The aim of the project is to validate the AI platform in a clinical study with regard to functionality, sensitivity, specificity, efficiency and reproducibility.

Expected results and effects: ** Denna text är maskinöversatt **

The expected effect is to see an increased reproducibility between diagnosing pathologists and hospitals, a sensitivity and specificity on par with a clinical specialist in uro-pathology. The AI platform is expected to diagnose and Gleason grade patients in accordance with international standards. The AI platform is expected to have the necessary clinical evidence regarding regulatory eligibility requirements for IVDR class C.

Approach and implementation: ** Denna text är maskinöversatt **

The development of the AI platform is expected to be completed and ready for use in June 2023, until then the integration is expected to be prepared to be implemented in the hospitals included in the clinical evaluation study.

All documentation and development work is documented in order to be compiled as easily as possible for ISO13485 certification and regulatory submission to "notified body" for IVDR class C proposal in 2024. The clinical study will be conducted and expected to be completed in December 2023.