Verify the Functions and Efficiency of Transtek Glass Body Fat Analyzer, GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, GBF-950-D.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Verify the accuracy of measure functions of device
研究概览
简要总结
The clinical protocol of the clinical testing of this device:
- Objective of the test: To verify the functions and efficiency of devices.
- Test methods and procedures: Comparison Test.
- DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.
- Comparison device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device).
- Study endpoints: Transtek devices and the predicate device are substantial equivalence.
- Statistical methodology used: Description of statistical methods.
- Result: Efficiencies of Transtek devices and predicate device are in the same level.
详细描述
Hospital Information The data was collected by Zhongshan City People's Hospital Clinical Investigator Team at Zhongshan City People's Hospital, No.2 Sunwen Dong Road, Zhongshan, Guangdong 528403, P. R. China.
Investigator: Dr. Stephen Feng, Leader; Fan Futao, Nurse A; Wu Yanting, Nurse B.
Contact Dr. James Zhu Tel: +86 760 88823818 Used Equipments DUT (Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.
Reference Device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device). Test Protocol
- Test Purpose:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male,female
排除标准
- •below 18 years old
结局指标
主要结局
Verify the accuracy of measure functions of device
时间窗: 8 days
Verify the functions and efficiency of these devices compare with a specified product.
次要结局
未报告次要终点
研究者
Leo Wang
Team leader
BTS International