Clinical Trail of Transtek Glass Body Fat Analyzer (GBFA)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Verify the Functions and Efficiency of Transtek Glass Body Fat Analyzer, GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, GBF-950-D.|
- Verify the accuracy of measure functions of device [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]Verify the functions and efficiency of these devices compare with a specified product.
|Study Start Date:||February 2011|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Device: Comparison test
Reference Device: Transtek Glass Body Analyzer, GBF-950, accuracy: ±0.1kg and range: 0-180kg.
DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.
Other Name: Brand name: Transtek
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
The aim of clinical test is to collect weight, body fat, total body water, bone mass, and muscle mass reading value which measured by DUT and reference device.
Note: GBF-733-W1 and BF-1039 have not bone mass functions. So it just collects weight, body fat, total body water, and muscle mass data.
The subject database shall contain at least 25 male and 25 female subjects and all above 18 years old. Patient's population analysis is bellow.
- Test procedures 1) Record the name, age, and gender values of each subject. 2) Let subject seated calmly for two minutes before test, dry the feet. 3) Use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value.
4) For each subject, repeat 3) to get 3 pairs measurements. 5) Repeat step 1) to 4) for every device (DUT: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D; and reference device: GBF-950).
6) Repeat step 1) to 5) for each subject. 5. Note:
- No motion and speaking are allowed during the measurement.
- All DUT use the same algorithms, have the same number of electrodes and contact the patient at the same body locations (feet), and operate on the same frequency.
- Test environment: Temperature: 22±1℃; Relative humidity: 40~50%.
|Zhongshan City People's Hospital|
|Zhongshan, Guangdong, China, 528403|
|Principal Investigator:||Stephen Feng, Director||Zhongshan City People's Hospital|