안면조직 고정용실의 객관적 임상평가 지표 제시에 관한 연구

초록

The increase in income level due to economic growth is leading to the expansion of the aesthetic medical device market, and this can be confirmed through many industry trend data. Since medical devices for aesthetic purchases are not included in the definition of medical device(Medical device law article 2), the definition of regulations is not clear compared to other medical devices. Many domestic medical device companies have focused on “wrinkle depth and wrinkle improvement” by directly reflecting the clinical data of previously approved facial tissue fixation threads for equivalence comparison, and there were many differences between this and the actual treatment applied to patients with facial tissue fixation threads. In this study, we confirmed the regulations on aesthetic medical devices, especially facial tissue fixation threads, in the United States and reviewed the points to be considered in the design of actual clinical trials for the safety and efficacy of practitioners and consumers. Among the various validity indices, we confirmed the CM&S (Computational Modeling and Simulation) guidelines and application cases that have been recently reviewed to secure the safety of many medical devices, and considered that facial tissue fixation threads perform physical actions in the body and are biodegradable materials, and confirmed the possibility that such analyses of mechanical, physical, and biodegradable properties can be a good reference when designing clinical trials. In the case of aesthetic medical devices including facial tissue fixation threads, there are abnormal cases in the market, but in many cases, surgery to return the device to its pre-procedure state is necessary due to treatment-related injuries. In this study, we will examine what safety and validity are required for approval of facial tissue fixation threads through the surveyed data, and study the scientific basis that can be provided by the introduction of CM&S (Computational Modeling and Simulation).

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