NC Thermometer (Gen 3) ISO 80601-2-56 Validation

Study Overview
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Brief Summary
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The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a reference clinical thermometer.

Detailed Description
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The purpose of this clinical study is to validate the clinical accuracy of the NC° Thermometer (Gen 3) according to the requirements of ISO 80601-2-56:2017. The NC° Thermometer (Gen 3) (the device under study (DUT)) is a predictive thermometer that operates in adjusted mode. The Welch Allyn oral thermometer (Welch Allyn Spot Vital Signs 420 SureTemp temperature module, Welch Allyn, San Diego, CA) with a measurement accuracy of ± 0.1 °C in monitor mode will be used the reference clinical thermometer (RCT). During the clinical study, subjects will be asked to perform three consecutive oral measurements with the DUT, and one oral measurement with the RCT.

Official Title
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NC Thermometer (Gen 3) ISO 80601-2-56 Validation

Conditions
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Febrile Illness, Healthy, Fever

Intervention / Treatment
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* Device: NC° Thermometer (Gen 3)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They are more than 5 years old They have not taken any antipyretic in the preceding 120 minutes They have no medical conditions which might impact the clinical accuracy validation results, such as inflammation at the measuring site (the mouth) They are not taking medications such as barbiturates, thyroid preparations, antipsychotics, and recent immunizations

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Temperature measurement<br>Each subject will have their temperature measured by both the NC° Thermometer (Gen 3) and the reference clinical thermometer. | Device: NC° Thermometer (Gen 3)<br>* The NC° Thermometer (Gen3) is used orally for the intermittent measurement and monitoring of human body temperature. The device can be used by adults and children over the age of 5 years old.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Bias | Clinical bias is the mean difference between the output temperatures of the NC° Thermometer (Gen 3) (DUT) and the reference clinical thermometer (RCT) for a specific reference body site (the mouth) when measured from a selected group of subjects. The clinical bias of the DUT defines closeness between the DUT output temperature and that of the RCT. | Up to 1 hour | 
| Limits of agreement | Dispersion of output temperatures around the clinical bias can be estimated by the standard deviation of the temperature differences between the DUT and the RCT as measured from multiple subjects. | Up to 1 hour | 
| Clinical repeatability | Clinical repeatability (sometimes called the perceived accuracy) is a measure of the consistency of repeated measurements with identical operating conditions when temperatures are taken within short time intervals from the same measuring site of the same subject by the same operator with the same intermittent clinical thermometer. Clinical repeatability is a pooled standard deviation of triplicate measurements over the population of subjects. | Up to 1 hour |