Body Fat Disorder Clinical Trial
Official title:
Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, 8 Models
The clinical protocol of the clinical testing of this device:
1. Objective of the test: To verify the functions and efficiency of devices.
2. Test methods and procedures: Comparison Test.
3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-835-N2, GBF-835-N2
Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1
Plus.
4. Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533.
5. Study endpoints: DUT and the comparison device are substantial equivalence.
6. Statistical methodology used: Description of statistical methods.
1. Test Purpose:
The aim of clinical test is to collect BMI, body fat, total body water, muscle mass,
bone mass, calorie, and visceral fat reading value which measured by DUT and reference
device.
2. Target Subject:
The subject database shall contain at least 30 male and 30 female subjects and all
above 10 years old.
3. 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-835-N2, GBF-835-N2 Plus, LS202-B1,
LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus; and
reference device: GBF-1251-B and BC-533).
6. Repeat step 1) to 5) for each subject.
4. Note:
1. No motion and speaking are allowed during the measurement.
2. All DUT use the same algorithms and contact the patient at the same body locations
(feet), and operate on the same frequency.
3. Test environment: Temperature: 22±1℃; Relative humidity: 40~70%.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
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