Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices. The main objectives of this study are: 1. To verify that the investigational devices and the reference medical devices have a reasonable deviation value. 2. To verify the consistency of repeated measurements of investigational devices.
This Study carried out in accordance with the ISO 80601-2-56: 2017, which included definitions for the age groups and sample sizes, the definition of fever, the flowchart for relevant procedures, and statistical methods for clinical performance. All subjects were measured by the reference device (electronic thermometer MT-B231) and three investigational devices under test evaluation (infrared forehead thermometer GE-TF03, infrared ear thermometer GE-TE06, and electronic thermometer MT-B321FB). For each subject, the reference device measured one time and each investigational device measured three times respectively.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
150
Infrared Forehead Thermometer (GE-TF03) is an investigational device intended to measure body temperature on the forehead. GE-TF03 took three measurements for each subject.
Infrared Ear Thermometer (GE-TE06) is an investigational device intended to measure body temperature in the ear canal. GE-TF06 took three measurements for each subject.
Electronic Thermometer (MT-B321FB) is an investigational device intended to measure body temperature on the temporal artery. MT-B321FB took three measurements for each subject.
Electronic Thermometer (MT-B231) is a reference device that measured axillary temperature one time for each subject.
Hsinchu MacKay Memorial Hospital
Hsinchu, Taiwan
HsinChu Municipal MacKay Memorial Hospital
Hsinchu, Taiwan
Clinical Bias
Mean Difference between investigational thermometer and reference thermometer.
Time frame: Through study completion, an average of 2 years
Limits of Agreement
The magnitude of a potential disagreement between investigational thermometer and reference thermometer.
Time frame: Through study completion, an average of 2 years
Clinical Repeatability
Pooled standard deviation of triplicate measurements over the entire population of subject
Time frame: Through study completion, an average of 2 years
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