Clinical Test for Transtek Glass Body Analyzer (GBA)
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: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15.
- Comparison device: Scaleman Body Fat Scales, FS-148BW1 (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 Analyzer, GBF-830, GBF-835, GBF-950, SA-15|
- Verify the accuracy of measure functions of device [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]Verify the functions and efficiency of these devices compare with a specified product.
|Study Start Date:||November 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Device: Comparison test
Scaleman Body Fat Scales, FS-148BW1, accuracy: ±0.1kg and range: 0-180kg.
Hospital Information The data was collected by West China Medical College Clinical Investigator Team at Wuhou District Hospital, No. 9 Tongzilin Road, Wuhou District, Chengdu 610041, P. R. China.
Investigator: Catharine Zhang, Nurse A; Vivian Luo, Nurse B; Dr. James Zhu, Sponsor.
Contact Dr. James Zhu Tel: +86 1330 8036568 Used Equipments DUT (Device Under Test): Transtek Glass Body Analyzer, GBF-830, GBF-835, GBF-950, and SA-15.
Reference Device: Scaleman Body Fat Scales, FS-148BW1 (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-835 has not total body water, bone mass, and muscle mass functions. So it just collects weight and body fat 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, gender, and height 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-830, GBF-835, GBF-950, and SA-15; and reference device: FS-148BW1).
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: 20±1℃; Relative humidity: 40~50%.