Healthy Clinical Trial
Official title:
The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers
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. ;
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