1st EFORT European Consensus: Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices

Innovations in Orthopaedics and Traumatology have contributed to the achievement of a high-quality level of care in musculoskeletal disorders and injuries over the past decades. The applications of new implants as well as diagnostic and therapeutic techniques in addition to implementation of clinical research, have significantly improved patient outcomes, reduced complication rates and length of hospital stay in many areas. However, the regulatory framework is extensive, and there is a lack of understanding and clarity in daily practice what the meaning of clinical & pre‐clinical evidence as required by the MDR is. Thus, understanding and clarity are of utmost importance for introduction of new implants and implant-related instrumentation in combination with surgical technique to ensure a safe use of implants and treatment of patients. Therefore EFORT launched IPSI, The Implant and Patient Safety Initiative, which starting from an inaugural workshop in 2021 issued a set of recommendations, notably through a subsequent Delphi Process involving the National Member Societies of EFORT, European Specialty Societies as well as International Experts. These recommendations provide surgeons, researchers, implant manufacturers as well as patients and health authorities with a consensus of the development, implementation, and dissemination of innovation in the field of arthroplasty. The intended key outcomes of this 1st EFORT European Consensus on “Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices”are consented, practical pathways to maintain innovation and optimisation of orthopaedic products and workflows within the boundaries of MDR 2017/745. Open Access practical guidelines based on adequate, state of the art pre-clinical and clinical evaluation methodologies for the introduction of joint replacements and implant-related instrumentation shall provide hands-on orientation for orthopaedic surgeons, research institutes and laboratories, orthopaedic device manufacturers, Notified Bodies but also for National Institutes and authorities, patient representatives and further stakeholders. We would like to acknowledge and thank the Scientific Committee members, all International Expert Delegates, the Delegates from European National & Specialty Societies and the Editorial Team for their outstanding contributions and support during this EFORT European Consensus

A Topology of Shared Control Systems—Finding Common Ground in Diversity

Shared control is an increasingly popular approach to facilitate control and communication between humans and intelligent machines. However, there is little consensus in guidelines for design and evaluation of shared control, or even in a definition of what constitutes shared control. This lack of consensus complicates cross fertilization of shared control research between different application domains. This paper provides a definition for shared control in context with previous definitions, and a set of general axioms for design and evaluation of shared control solutions. The utility of the definition and axioms are demonstrated by applying them to four application domains: automotive, robot-assisted surgery, brain–machine interfaces, and learning. Literature is discussed for each of these four domains in light of the proposed definition and axioms. Finally, to facilitate design choices for other applications, we propose a hierarchical framework for shared control that links the shared control literature with traded control, co-operative control, and other human–automation interaction methods. Future work should reveal the generalizability and utility of the proposed shared control framework in designing useful, safe, and comfortable interaction between humans and intelligent machines