Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353490
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-20
Brief Title:
The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers
Sponsor:
Geon Corporation
Organization:
Geon Corporation
Study Overview
Official Title:
The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None