Catalog of Regulatory Science Tools to Help Assess New Medical Devices
This regulatory science tool (RST) is a dataset of facial and oral temperatures collected from infrared thermography of more than 1000 human volunteers that may be helpful in evaluating the performance of thermal imaging systems and thermometers.
Technical Description
Two infrared thermography devices, also known as infrared thermographs (IRTs) or thermal cameras, were used for data collection: IRT-1 and IRT-2. Data from 1020 subjects measured with IRT-1 and 1009 subjects measured with IRT-2 were acquired and included in the dataset. About 11% of these subjects exhibited reference oral temperatures above 37.5 °C. The demographics of study subjects and the methodology employed for the study execution, data collection, and initial processing can be found in our publications (see the Testing section).
The raw data from the human volunteer study includes: thermal images captured with the two IRTs, visible light images acquired from a webcam, and oral temperature data measured with an oral thermometer. All four sets of images/data were acquired in the same session. Based on these raw data, temperatures at different facial locations for each subject were extracted and a total of 26 facial temperature variables were defined. In addition, we recorded the oral temperatures of each subject twice, under two operation modes (fast mode and monitor mode) of the oral thermometer each time. This database includes the average value for each mode. Furthermore, demographic information such as sex, age, ethnicity, ambient temperature, relative humidity, measuring distance, cosmetic use, and measurement time and date were recorded for each subject and is listed in the dataset. Some subjects have incomplete records, which are indicated as empty cells in the database.
To comply with HIPAA regulations regarding subject confidentiality, only patient IDs based upon their measurement date and not names are listed. Furthermore, the ages of the subjects are shown in 5-year increments, except for those over 60 years old, who were grouped together. The measurement date is retained in the database to enable study of seasonal effects.
Intended Purpose
The dataset is designed to support the development and evaluation of thermal imaging systems for clinical use and health care applications. It is intended to improve the measurement of elevated body temperature (EBT) by providing a comprehensive dataset for analyzing temperature correlations across body sites and evaluating the impact of various demographic and environmental factors.
Testing
The dataset underwent rigorous data collection and processing to ensure accuracy. Raw data (images) from 1115 subjects were collected, and datasets from subjects with poor quality images or incomplete or inaccurate records were excluded. This resulted in the final raw data of 1020 and 1009 subjects for the two IRTs. The raw data was processed to extract temperatures at different facial locations, with multiple verification steps performed to ensure reliability. The dataset's validity is supported in previous peer-reviewed publications:
- Effects of external factors on IRT accuracy (https://doi.org/10.3390/s23188011)
- Methods to assess IRT accuracy and the accuracy of the two IRTs used for data collection (https://doi.org/10.1371/journal.pone.0203302)
- Method to accurately identify facial locations and extract the dataset from raw images (https://doi.org/10.3390/s18010125)
- Diagnostic effectiveness of standardized IRT-based temperature measurement and effects of facial measurement locations (https://doi.org/10.1117/1.JBO.25.9.097002)
- Methods and metrics for the clinical accuracy assessment of IRTs (https://doi.org/10.3390/s22010215)
Limitations
The dataset has several limitations, including a skewed age distribution, with 95% of subjects under 30 years old and about half between 18-21 years old possibly because the data were collected on a college campus. The distribution of the dataset limits its ability to make conclusions across the general population. Additionally, the data were collected under controlled environmental conditions, and the results may not be applicable to extreme conditions with high or low temperatures or high humidity levels. Documentation is provided to ensure correct usage, but users should be aware of these limitations when interpreting the data.
Supporting Documentation
- The dataset has been released to the public as a repository on PhysioNet (https://doi.org/10.13026/3bhc-9065) after a quality check.
- The dataset has also been uploaded to GitHub (https://github.com/dbp-osel/Facial-and-oral-temperature-data.git).
Contact
Tool Reference
- RST Reference Number: RST24MD21.01
- Date of Publication: 10/16/2025
- Recommended Citation: U.S. Food and Drug Administration. (2025). Dataset of Infrared Facial and Oral Temperatures from Human Volunteers (RST24MD21.01). https://cdrh-rst.fda.gov/dataset-infrared-facial-and-oral-temperatures-human-volunteers