Clinical Test for Transtek Glass Body Analyzer (GBA)

Verify the Functions and Efficiency of Transtek Glass Body Analyzer, GBF-830, GBF-835, GBF-950, SA-15

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. DUT: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15.
4. Comparison device: Scaleman Body Fat Scales, FS-148BW1 (Predicate Device).
5. Study endpoints: Transtek devices and the predicate device are substantial equivalence.
6. Statistical methodology used: Description of statistical methods.
7. Result: Efficiencies of Transtek devices and predicate device are in the same level.

Study Overview

• Status: Completed
• Conditions: Weight; Body Fat Disorder; Bone Mass
• Intervention / Treatment: Device: Comparison test

Detailed Description

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

1. Test Purpose:

   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.

2. Target Subject:

   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.

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-830, GBF-835, GBF-950, and SA-15; and reference device: FS-148BW1).

6) Repeat step 1) to 5) for each subject. 5. Note:

1. No motion and speaking are allowed during the measurement.
2. 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.
3. Test environment: Temperature: 20±1℃; Relative humidity: 40~50%.

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Wuhou District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The subject population included patients whose age is above 18 years old. Male or Female.

Description

Inclusion Criteria:

• male,female

Exclusion Criteria:

• below 18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Body Analysis	Device: Comparison test; Scaleman Body Fat Scales, FS-148BW1, accuracy: ±0.1kg and range: 0-180kg.; Other Names: Brand names: Scaleman; Serial numbers: SBFS1002-351; Code name: FS-148BW1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verify the accuracy of measure functions of device	Verify the functions and efficiency of these devices compare with a specified product.	10 days

Collaborators and Investigators

• Sponsor: Leo Wang
• Collaborators: West China Hospital
• Investigators: Principal Investigator: Guoqing Li, Director, Wuhou District Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 12, 2011
• First Submitted That Met QC Criteria: February 12, 2011
• First Posted (Estimate): February 15, 2011

Study Record Updates

• Last Update Posted (Estimate): December 23, 2011
• Last Update Submitted That Met QC Criteria: December 22, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: muscle mass; bone mass; weight; total body water; body fat
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: Transtek GBA; BTS-TRANS02 (Other Identifier: BTSInternational)