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A communication over an Internet Protocol (IP) based network fails if an endpoint sends packets that are too big to reach their destination and if the sender is unable to detect that. The node on the path that drops these packets should respond with a Packet Too Big (PTB) message. However, multiple scenarios exist in which the sender will not receive a PTB message. Even if it does, it refrains from using the information in case it suspects that a potential attacker forged the message. In particular, we are not aware of any implementation of the secure transport protocol QUIC (e.g., used by HTTP/3) that processes PTB messages. In this paper, we present a novel parameterizable PTB detection algorithm for reliable transport protocols that does not depend on PTB messages. We further describe how to integrate our algorithm into QUIC, present results from an evaluation using the algorithm within a QUIC simulation model and, based on these results, suggest concrete parameter values.
Additive manufacturing (AM) has been growing continuously over the past 20 years, enabling unprecedented tailoring to the anatomy of each patient. In Europe, custom-made devices qualify for an exemption and pass a simplified approval process. New technologies, like AM, provoke questions about the adequacy of the current regulatory framework for custom-made devices. This article addresses the regulatory requirements for such devices in Europe and discusses the implications for AM. It concludes that the legal framework for custom-made devices entails uncertainties which need to be resolved to guide manufacturers through the regulatory requirements, highlighting the specific areas of focus for AM.
The use of computational modeling and simulation (CMS) as a tool for gaining insight into the technical performance and safety of medical devices has emerged continuously over the past years. However, to rely on information and decisions derived from model predictions, it is essential to establish model credibility for the specific context of use. Limited regulatory requirements and lack of consensus on the level of verification and validation activities required result in rare use of CMS as a source of evidence in the medical device approval process. The American Society of Mechanical Engineers (ASME) developed a risk-informed framework to establish appropriate credibility requirements of a computational model: the ASME V&V 40?2018 standard. This paper aims to outline the concepts of this standard and to demonstrate its application using an example from the orthotics field. The necessary steps to establish model credibility for a custom?made 3D printed wrist hand orthosis (WHO) are presented. It is shown that the credibility requirements of each verification and validation activity depend on model risk by applying two different contexts of use to the same computational model.