Methods for preclinical validation of software as a medical device

Software as a medical device is subject to dedicated regulatory requirements before it can be used on human beings. The certification process in Europe requires that sufficient data on clinical benefits are available before the device is CE marked. This position paper describes our proposal of a risk-based approach to technical and preclinical validation of software as medical devices. This approach ensures that all technical solutions for safety are implemented in the software and that all information for safe use is consistent before the software can be made available to patients. This approach is compliant to the main international standards ISO 13485 on quality systems and ISO 14971 on risk management and therefore ensures regulatory compliance as well as patient protection. This integrated approach allows the designers of the software to integrate regulatory and safety testing in the technical testing of the candidate release version of the device. This approach ensures patient safety and regulatory compliance at the same time as technical functionality

Imaging of Phase Objects using Partially Coherent Illumination

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A novel method for validating multi-classifiers. A case study for ICF-based health status classification

In this paper, we propose a novel method for the validation of a multi-classification model according to the intended use and aim of a device for health status classification and the clinical needs of the practitioners involved

Usability assessment of an intraoperative planning software

Usability is a crucial aspect of medical device safety. The brand-new European Regulation requires the manufacturer to assess the usability of the new medical devices. In this study, we evaluate the usability of a new medical device intended to assist the intraoperative planning with the visualization of 3d patient-specific organ models. The usability study started from the early stage of the device design and iterated through an early formative, completed with desk-based activities, late formative, completed with a focus group, and summative phase, that comprised a user test, and questionnaire filling. The identified usability issues are mitigated, the safety of the device user interface is confirmed and the training contents are defined and confirmed. Additional information regarding the user experience is collected and analyzed to identify further improvements of the device

IMU-based classification of resistive exercises for real-time training monitoring on board the international space station with potential telemedicine spin-off

The microgravity exposure that astronauts undergo during space missions lasting up to 6 months induces biochemical and physiological changes potentially impacting on their health. As a countermeasure, astronauts perform an in-flight training program consisting in different resistive exercises. To train optimally and safely, astronauts need guidance by on-ground specialists via a real-time audio/video system that, however, is subject to a communication delay that increases in proportion to the distance between sender and receiver. The aim of this work was to develop and validate a wearable IMU-based biofeedback system to monitor astronauts in-flight training displaying real-time feedback on exercises execution. Such a system has potential spin-offs also on personalized home/remote training for fitness and rehabilitation. 29 subjects were recruited according to their physical shape and performance criteria to collect kinematics data under ethical committee approval. Tests were conducted to (i) compare the signals acquired with our system to those obtained with the current state-of-the-art inertial sensors and (ii) to assess the exercises classification performance. The magnitude square coherence between the signals collected with the two different systems shows good agreement between the data. Multiple classification algorithms were tested and the best accuracy was obtained using a MultiLayer Perceptron (MLP). MLP was also able to identify mixed errors during the exercise execution, a scenario that is quite common during training. The resulting system represents a novel low-cost training monitor tool that has space application, but also potential use on Earth for individuals working-out at home or remotely thanks to its ease of use and portability

Lipid profile during pregnancy in HIV-infected women

Purpose: We investigated the evolution of serum lipid levels in HIV-infected pregnant women and the potential effect of antiretroviral treatment during pregnancy using data from a national surveillance study. Method: Fasting lipid measurements collected during routine care in pregnancy were used, analyzing longitudinal changes and differences in lipid values at each trimester by protease inhibitors (Pls) and stavudine use. Multivariate analyses were used to control for simultaneous factors potentially leading to hyperlipidemia. Study population included 248 women. Results: Lipid values increased progressively and significantly during pregnancy: mean increases between the first and third trimesters were 141.6 mg/dL for triglycerides (p <.001), 60.8 mg/dL for total cholesterol (p <.001), 13.7 mg/dL for HDL cholesterol (p <.001), and 17.8 mg/dL for LDL cholesterol (p =.001). At all trimesters, women on PIs had significantly higher triglyceride values compared to women not on Pis. The effect of Pls on cholesterol levels was less consistent. Stavudine showed a dyslipidemic effect at first trimester only. Multivariate analyses confirmed these observations and suggested a potential role of other cofactors in the development of hyperlipidemia during pregnancy. Conclusion: The changes observed point to the need to further explore the causes and the clinical correlates of hyperlipidemia during pregnancy in women with HIV

Downstream Intensification Effects Associated with CO2 Laser Mitigation of Fused Silica

Mitigation of 351nm laser-induced damage sites on fused silica exit surfaces by selective CO{sub 2} treatment has been shown to effectively arrest the exponential growth responsible for limiting the lifetime of optics in high-fluence laser systems. However, the perturbation to the optical surface profile following the mitigation process introduces phase contrast to the beam, causing some amount of downstream intensification with the potential to damage downstream optics. Control of the laser treatment process and measurement of the associated phase modulation is essential to preventing downstream 'fratricide' in damage-mitigated optical systems. In this work we present measurements of the surface morphology, intensification patterns and damage associated with various CO{sub 2} mitigation treatments on fused silica surfaces. Specifically, two components of intensification pattern, one on-axis and another off-axis can lead to damage of downstream optics and are related to rims around the ablation pit left from the mitigation process. It is shown that control of the rim structure around the edge of typical mitigation sites is crucial in preventing damage to downstream optics

Toll-like receptor 4 and high-mobility group box-1 are involved in ictogenesis and can be targeted to reduce seizures

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Detectability of colorectal neoplasia with fluorine-18-2-fluoro-2-deoxy-D-glucose positron emission tomography and computed tomography (FDG-PET/CT)

The purpose of this study was to analyze the detectability of colorectal neoplasia with fluorine-18-2-fluoro-2-deoxy-d-glucose positron emission tomography/computed tomography (FDG-PET/CT). Data for a total of 492 patients who had undergone both PET/CT and colonoscopy were analyzed. After the findings of PET/CT and colonoscopy were determined independently, the results were compared in each of the six colonic sites examined in all patients. The efficacy of PET/CT was determined using colonoscopic examination as the gold standard. In all, 270 colorectal lesions 5 mm or more in size, including 70 pathologically confirmed malignant lesions, were found in 172 patients by colonoscopy. The sensitivity and specificity of PET/CT for detecting any of the colorectal lesions were 36 and 98%, respectively. For detecting lesions 11 mm or larger, the sensitivity was increased to 85%, with the specificity remaining consistent (97%). Moreover, the sensitivity for tumors 21 mm or larger was 96% (48/50). Tumors with malignant or high-grade pathology were likely to be positive with PET/CT. A size of 10 mm or smaller [odds ratio (OR) 44.14, 95% confidence interval (95% CI) 11.44-221.67] and flat morphology (OR 7.78, 95% CI 1.79-36.25) were significant factors that were associated with false-negative cases on PET/CT. The sensitivity of PET/CT for detecting colorectal lesions is acceptable, showing size- and pathology-dependence, suggesting, for the most part, that clinically relevant lesions are detectable with PET/CT. However, when considering PET/CT for screening purposes caution must be exercised because there are cases of false-negative results

Sport in a youth prison: male young offenders' experiences of a sporting intervention

The numbers of children under the age of 18 being incarcerated in England and Wales has decreased of late, with official figures indicating that the current population of just over 1500 has halved during the last decade. But levels of reoffending among children released from prison remain the highest, with three out of four young people being reconvicted within one year of release from juvenile custody. Despite the fact that the overwhelming majority of community-based sports projects target children and young people, when it comes to incarcerated populations, sporting initiatives are less prevalent. Where sport has become well established as a useful social cohesion/inclusion strategy in community settings, some of these approaches have been translated into custodial settings. Resulting research has often proclaimed sporting pursuits as a modern-day panacea in terms of their social, psychological and emotional benefits, yet few studies have explored the nuances of sports-based interventions within secure settings. This paper comprises a small-scale, qualitative study of one such intervention in a Young Offender Institution in the South of England. Placing respondent accounts at the centre of the analysis, the paper sheds light on the practicalities of programme delivery by uncovering the motivating factors behind participant engagement whilst exploring broader notions of personal development. The paper concludes by highlighting that sport/physical activity can confer significant psychosocial benefits and promote the rehabilitation of young people leaving custody, particularly when integrated into wider programmes of support and provision