Medical devices are designed, tested, and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international standards, can foster innovation while respecting regulatory requirements. The purpose of this paper is to review the upcoming European Union (EU) Medical Device Regulations 2017/745 and 2017/746, the current and future International Electrotechnical Commission (IEC) and International Organization for Standardization (ISO) standards that set methods for design and validation of medical devices, with a focus on wearable sensors. Risk classification according to the regulation is described. The international standards IEC 62304, IEC 60601, ISO 14971, and ISO 13485 are reviewed to define regulatory restrictions during design, pre-clinical validation and clinical validation of devices that include wearable sensors as crucial components. This paper is not about any specific innovation but it is a toolbox for interpreting current and future regulatory restrictions; an integrated method for design planning, validation and clinical testing is proposed. Application of this method to design wearable sensors should be evaluated in the future in order to assess its potentially positive impact to fostering innovation and to ensure timely development.
Purpose: Statistical shape modeling provides a powerful tool for describing and analyzing human anatomy. By linearly combining the variance of the shape of a population of a given anatomical entity, statistical shape models (SSMs) identify its main modes of variation and may approximate the total variance of that population to a selected threshold, while reducing its dimensionality. Even though SSMs have been used for over two decades, they lack in characterization of their goodness of prediction, in particular when defining whether these models are actually representative for a given population.
Methods: The current paper presents, to the authors' knowledge, the most extent lower limb anatomy shape model considering the pelvis, femur, patella, tibia, fibula, talus, and calcaneum to date. The present study includes the segmented training shapes (n = 542) obtained from 271 lower limb CT scans. The different models were evaluated in terms of accuracy, compactness, generalizability as well as specificity.
Results: The size of training samples needed in each model so that it can be considered population covering was estimated to approximate around 200 samples, based on the generalizability properties of the different models. Simultaneously differences in gender and patterns in left-right asymmetry were identified and characterized. Size was found to be the most pronounced sexual discriminator whereas intra-individual variations in asymmetry were most pronounced at the insertion site of muscles.
Conclusion: For models aimed at population covering descriptive studies, the number of training samples required should amount a sizeable 200 samples. The geometric morphometric method for sex discrimination scored excellent, however, it did not largely outperformed traditional methods based on discrete measures.