ObjectiveTo review the registration and technical data for sodium hyaluronate facial derma fillers. MethodsRecent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed. ResultsThe aspects on registration for sodium hyaluronate facial derma fillers include nominating the product, dividing registration unit, filling in a registration application form, preparing the technical data, developing the standard, and developing a registration specification. ConclusionThe main difficulty in registration is how to prepare the research data of that product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.
ObjectiveTo review the registration and technical data for breast implants. MethodsRecent literature concerning registration for breast implants was reviewed and analyzed. ResultsThe aspects on registration for breast implants are complicated. The major aspects include providing technical data, establishing develop standard, progress type test, and developing the registration specification. ConclusionThe manufacturers need to be well aware of the risk of this kind of product and have the full ability to conduct the researching and developing. Only the strict risk controlling can ensure the safety and effectiveness of the product.
In order to calibrate the hand-eye transformation of the surgical robot and laser range finder (LRF), a calibration algorithm based on a planar template was designed. A mathematical model of the planar template had been given and the approach to address the equations had been derived. Aiming at the problems of the measurement error in a practical system, we proposed a new algorithm for selecting coplanar data. This algorithm can effectively eliminate considerable measurement error data to improve the calibration accuracy. Furthermore, three orthogonal planes were used to improve the calibration accuracy, in which a nonlinear optimization for hand-eye calibration was used. With the purpose of verifying the calibration precision, we used the LRF to measure some fixed points in different directions and a cuboid’s surfaces. Experimental results indicated that the precision of a single planar template method was (1.37±0.24) mm, and that of the three orthogonal planes method was (0.37±0.05) mm. Moreover, the mean FRE of three-dimensional (3D) points was 0.24 mm and mean TRE was 0.26 mm. The maximum angle measurement error was 0.4 degree. Experimental results show that the method presented in this paper is effective with high accuracy and can meet the requirements of surgical robot precise location.
ObjectiveTo investigate the awareness situation on the ARRIVE guideline and the Gold Standard Publication Checklist (GSPC) of animal experiments in researchers in animal experiments field in Lanzhou city, in order to improve the promotion of the two reporting guidelines in China. MethodsA self-designed questionnaire was used to investigate the clinical graduate students and teachers in medical college in Lanzhou city. The investigation contents mainly included the basic information of the respondents, the awareness situation on the ARRIVE guideline, GSPC and other medical reporting guidelines. SPSS 21.0 software was used for data analysis. ResultsA total of 329 questionnaires (40 were from teachers and 289 were from graduate students) were issued, of which, 287 questionnaires were effective. The results showed that the awareness rate on the ARRIVE guideline and GSPC in clinical graduate students and teachers in medical college in Lanzhou city were 11.8% and 12.5%, respectively, and there was no significant difference between students and teachers in awareness rate (P=0.903). The survey approaches, the age, education, job, and the organization of the respondents were all not the influence factors of awareness rate (P>0.05). The respondents knew about the reporting guidelines mainly through the website (33.4%), related studies (21.2%) and academic reports (17.4%). ConclusionThe awareness rate on the ARRIVE guideline and GSPC is relative low in researchers in animal experiments field in Lanzhou city, and it needed to take purposeful measures to promote and popularize them.