This paper introduces the safety and effectiveness requirements of medical device software. And it discusses the methods on evaluating medical device software from two aspects, the design and development process of the software and software products.
Equipment Safety ; Equipment and Supplies ; Software ; Software Validation

PURPOSE: The purpose of this study was to develop dedicated software for quantitative analysis of the airways and to validate the software using airway phantoms and excised swine lung. MATERIALS AND METHODS: The dedicated software was validated in airway phantoms and excised swine lung through comparison of the actual values with the measurements acquired with dedicated software. The accuracy of the measurements according to the reconstruction methods (standard, lung, sharp) and spatial resolution were compared using airway phantoms. Repeatability of the measurement of airway phantoms was assessed with follow-up CT scans three months later. RESULTS: Airway dimension measurements obtained in airway phantoms and excised swine lung showed good agreements with actual values. Airway measurements were more accurate when the sharp reconstruction algorithm was used and when the spatial resolution was improved using pixels smaller than conventional size. There was good agreement between the initial airway measurements and those obtained three months later. CONCLUSION: We developed and validated dedicated software for quantitative airway measurement. Recon-struction with sharp algorithms and high spatial resolution images is recommended for obtaining airway measurements.
Bronchi ; Follow-Up Studies ; Lung ; Phantoms, Imaging ; Software Validation ; Swine ; Tomography, X-Ray Computed

Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.
Clinical Trials as Topic ; Database Management Systems ; standards ; Information Storage and Retrieval ; standards ; Software Validation

OBJECTIVETo develop the dietary exposure evaluation model software accredited of Chinese intellectual property rights and to verify the rationality and accuracy of the results from the probabilistic model in Chinese dietary exposure evaluation model software according to international standards.

METHODSThe software of SAS was used to build various evaluation model based on the data from Chinese dietary survey and the chemical compound in food surveillance and to design an operation interface. The results from probabilistic dietary exposure model for children 2 - 7 years old were compared with that from duplicate portion study of 2-7 years children dietary exposure in Jinhu, Jiangsu province in order to analyze the rationality of model. The results from probabilistic model of dietary exposure were compared with the results from @Risk software to verify the correction of the probabilistic model by using the same data of randomly selected 10 000 study subjects from national dietary survey. While, the mean drift was used as an internal index to illustrate the accuracy of the computation.

RESULTSChinese dietary exposure evaluation software was developed successfully. On the rationality, the results from probabilistic model were lower than that from the point estimation (e.g., cucumber: the result of point estimation of acephate was 4.78 microg x kg(-1) x d(-1), while the results of probabilistic model which was 0.39 microg x kg(-1) x d(-1)). Meanwhile the results from probabilistic model were higher than the results of duplicate portion study (on the P95, the result of probabilistic model of Pb exposure in children was 11.08 microg x kg(-1) x d(-1), while the results of duplicate portion study was 5.75 microg x kg(-1) x d(-1)). On accuracy, the results from @Risk and the probabilistic model were highly consistent (on the P95, the result of probabilistic assessment of acephate diet exposure was 4.27 microg x kg(-1) x d(-1), while the results of duplicate portion study was 4.24 microg x kg(-1) x d(-1)), and the mean drift was of random distribution, the drift region varied from 0.05% to 11.9%.

CONCLUSIONThe results computed by the software of Chinese dietary exposure evaluation model are reliable and reasonable, which is a meaningful step to improve the dietary exposure evaluation technique in China.

Child ; Child, Preschool ; China ; Consumer Product Safety ; Diet ; statistics & numerical data ; Humans ; Models, Statistical ; Software Design ; Software Validation

OBJECTIVE: To establish standardized methods and parameters of the isolated heart coronary angiography through the experiment of in vitro porcine heart by MSCT. METHODS: Based on different perfusion volume (50, 60 and 70 mL) and different perfusion-imaging time (5, 10 and 20 min), the in vitro porcine coronary artery was injected liposoluble and water-soluble contrast agents using remodel angiography equipment and scanned by MSCT. And the 3D image results were compared. The images were recorded and evaluated by 2 radiologists and analyzed by statistical software. RESULTS: Liposoluble contrast agent affected the images by damaging and infiltrating the fats around the coronary artery, while the water-soluble contrast agent didn't affect the images. The groups with 60 mL or 70 mL perfusion and 5 min perfusion-imaging time had the best images. CONCLUSION The suitable parameters of the angiography lay the foundation of postmortem coronary angiography.
Animals ; Coronary Angiography/veterinary* ; Coronary Vessels/diagnostic imaging* ; Heart ; Imaging, Three-Dimensional/methods* ; In Vitro Techniques ; Multidetector Computed Tomography/veterinary* ; Predictive Value of Tests ; Sensitivity and Specificity ; Software ; Software Validation ; Swine

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, ‘digital exceptionalism’ (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.
Artificial Intelligence ; Delivery of Health Care ; Device Approval ; Diagnosis ; Diagnostic Imaging ; Humans ; Insurance Coverage ; Korea ; Patient Care ; Societies ; Software Validation ; United States ; United States Food and Drug Administration