ABSTRACT
Animal study plays a key role to evaluate the safety and effectivity of medical devices. This study aims to share evaluated consideration on the role, general principles, necessity, study design and quality management system of animal study, in order to improve the quality of animal study and reduce unnecessary study.
Subject(s)
Animals , Equipment and Supplies , Models, AnimalABSTRACT
With the advantages of inflatable bone expander in the treatment of osteoporotic vertebral compression fractures, the number of applications for registration of such products is increasing. Based on the characteristics of the medical device, this article analyzed and summarized the relevant requirements for the basic information, product performance research, product manufacturing, clinical evaluation, and product instructions that should be focused on the registration application dossiers, as well as comply with the requirements of CMDE. The focus of the registration application for Inflatable Bone Expander should be the standardization of the application dossiers, while the difficulty was the scientific rationality of the research data. Comments and suggestions are provided to relevant practitioners on standardization of registration application dossiers. It may help them to optimize the quality of registration application dossiers while improve the efficiency of registration applications.
Subject(s)
Humans , Bone Cements , Fractures, Compression , Spinal Fractures , Treatment OutcomeABSTRACT
OBJECTIVE@#This paper introduces the key content and background of Technical Review Guidance for the Registration of Personalized Additive Manufacturing Medical Devices of Passive Implantable Bone, Joint and Oral Hard Tissues.@*METHODS@#The core contents and importance of the construction of personalized design validation and verification and additive manufacturing system are described respectively.@*RESULTS@#The personalized design needs to be carried out under the control of interactive cooperation between healthcare professional and engineer. And the performance of personalized device must be validated and verified completely. At the same time, in view of the particularity of the quality management system of additive manufacturing, the technical focus is expounded.@*CONCLUSIONS@#New ideas and methods shall be used in evaluate and administrate personalized additive manufacturing medical device.
Subject(s)
Printing, Three-Dimensional , Prostheses and ImplantsABSTRACT
Electroencephalography (EEG) signals are strongly correlated with human emotions. The importance of nodes in the emotional brain network provides an effective means to analyze the emotional brain mechanism. In this paper, a new ranking method of node importance, weighted -order propagation number method, was used to design and implement a classification algorithm for emotional brain networks. Firstly, based on DEAP emotional EEG data, a cross-sample entropy brain network was constructed, and the importance of nodes in positive and negative emotional brain networks was sorted to obtain the feature matrix under multi-threshold scales. Secondly, feature extraction and support vector machine (SVM) were used to classify emotion. The classification accuracy was 83.6%. The results show that it is effective to use the weighted -order propagation number method to extract the importance characteristics of brain network nodes for emotion classification, which provides a new means for feature extraction and analysis of complex networks.
ABSTRACT
This article summarizes the attribute conditions to the combination products designation from 2009 to 2018 in China,analyzes the common problems of combination products attribution definition.It is hoped to be helpful for researchers and manufacturers of combination products.
Subject(s)
China , Equipment and Supplies , Terminology as TopicABSTRACT
Recently, the registration of artificial hip prosthesis products increased year by year. In the new version of the provisions for medical device registration, the domestic or import of such products in the registration declaration may need to complete a clinical trial in the country. How to carry out scientific clinical trials of the product design is the common concern of enterprises and clinical trial institutions. To review the guideline and literature concerning registration for artificial hip prosthesis, the focus on clinical trial design of artificial hip prosthesis include clinical inclusion, evaluation standard, sample size. Through the discussion, we hope to provide advice and guidance for clinical trials of this kind of products.