儿科内窥镜适应症如何确定?基于PUSEN设备临床数据解析

2025-12-06 MedSci xAi 发表于广东省
本文基于PUSEN内窥镜设备临床数据分析,详解儿科适应症扩展依据。涵盖8个月至17岁患儿泌尿系统结石治疗案例,解析单一文献支持下的适应症定义策略与临床验证要求。
The provided text is already in English. However, I can ensure that the content is clear and professionally formatted for a medical journal: From the above analysis, medical conditions and target groups for the equivalent device have been identified from clinical data. For the similar equipment (PUSEN) used in pediatrics, currently only the A8 literature data is available. This literature covers a patient age range of 8 months to 17 years, with a total of 39 cases, and it is used for treating urinary system stone diseases. The other literature (A1-A7, A9-A14) was all applicable to adults for the diagnosis and treatment. Therefore, the intended use has been defined as for adults and children over 8 months of age.
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