Software Using Artificial Intelligence Algorithms for Clinical Practice

… (licenses/subscriptions) for the duration of the contract, - ensuring operation, availability, updates and technical support within the Fulfilment Service includes in particular: • delivery of medical devices in the form of software meeting the requirements of MDR (EU) 2017/745, • their integration into the contracting authority's information systems (PACS), • putting them into live operation, • providing service, technical support and updates for the duration of the contract. For the entire duration of the contract, the Contractor will be insured against liability for damage caused in connection with the performance of the contract, with a minimum indemnity limit of CZK 5,000,000 per insured event for each part of the public contract. The public contract is divided into 2 separate parts: Part 1 VZ - AI Software for Prostate Cancer Screening Using Artificial Intelligence Algorithms Part 2 VZ - Software Using Artificial Intelligence Algorithms in Chest X-ray Diagnosis · The subject of this part of the public contract is the supply, implementation, integration and support of an artificial intelligence-based software solution designed to support clinical decision-making in the evaluation of magnetic resonance (MR) of the prostate. The software offered must be a medical device within the meaning of Article 2(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR) and must be properly placed on the market in the European Union. The system must be designated as a clinical support tool for the detection, localization and evaluation of lesions suspected of clinically significant prostate cancer. The aim of the implementation of the system is in particular: • increasing the quality and standardization of prostate MRI evaluation, • supporting early detection of clinically significant findings, • reducing variability among evaluators, • streamlining the radiological workplace workflow, • promoting multidisciplinary cooperation (radiology – urology). The system shall not serve as a substitute for clinical decision-making by a physician; the final diagnostic decision is always made by an authorised health professional. · The subject of this part of the contract is the supply, implementation, integration and operation of an artificial intelligence-based software solution designed to support clinical decision-making in the evaluation of X-ray (RTG) images of the chest. The software offered must be a medical device within the meaning of Article 2(1) of Regulation (EU) 2017/745 (MDR) and must be properly placed on the market in the European Union. The system is intended as a tool for clinical support (decision-support) in the detection and evaluation of pathological findings on chest X-rays. The system will be operated mainly at the Department of Imaging Methods and urgent reception of the University Hospital at St. Anne's in Brno and possibly also at other workplaces of the contracting authority. The final clinical decision is always made by a healthcare professional.