(66 days)
The Body Temperature Software (BTS) App is a software-only mobile medical application intended for over-the- counter (OTC) use with compatible mobile computing platforms that includes a general purpose infrared sensor for the intermittent determination of human body temperature on people of all ages.
The Body Temperature Software ("BTS") mobile application ("App"), is a Software as a Medical Device (SaMD) that leverages an infrared sensor from qualified compatible general computing platforms (i.e. Google Pixel Smartphone) to provide on-demand body temperature measurements. The BTS App is based on well understood infrared measurement technology. The app leverages consumer general purpose computing platforms to collect the inputs for measurement.
The BTS App is intended to be operated by users above 18 years of age and can be used to measure body temperature for themselves or other individuals. To collect the input temperature data, the user is guided to conduct a non-contact forehead sweep starting at the center of the forehead and ending at the temple, thereby passing over the temporal artery, which corresponds to the highest temperature point on the forehead. This temperature data is then used as an input into the BTS App to convert the measured skin temperature data into a body temperature value. Before and during this measurement process, the BTS App performs a series of signal quality checks to ensure the validity of the temperature data collected. Additionally, to aid users with the interpretation of their measurements, the BTS App also has the option to present users with a color-coded temperature quide to indicate if the measurement falls within normal limits or indicative of an elevated state based on wellrecognized body temperature ranges for the specified age of the individual being measured.
The BTS App collects the temporal artery temperature, which is processed using a polynomial function to approximate a rectal temperature.
Here's a breakdown of the acceptance criteria and study information for the Body Temperature Software (BTS) based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Laboratory Accuracy | ±0.5°F (±0.3°C) |
| Measurement Range | 94.1°F-109.4°F (34.5°C-43°C) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "Validation Testing" and "Laboratory accuracy testing," implying a test set was used, but details are omitted in this summary.
3. Number of Experts and Qualifications for Ground Truth Establishment
Not applicable. The document describes laboratory accuracy testing based on a "reference body rectal site" and adherence to ISO standards, not expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. The reported testing focuses on device accuracy against a physical reference (rectal temperature) in a laboratory setting, not subjective expert judgment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document focuses on the device's standalone performance and its equivalence to a predicate device, not on human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone (algorithm only) performance study was conducted. The "Laboratory Accuracy" data, demonstrating ±0.3°C accuracy, directly reflects the algorithm's performance in determining body temperature from IR sensor input. The device description explicitly states it's a "Software as a Medical Device (SaMD)" that processes sensor data.
7. Type of Ground Truth Used
The ground truth used for the accuracy assessment was a reference body rectal site. The BTS app "processes the sensor data collected during the sweep and determines the body temperature" and "The displayed temperature is that of the temporal artery which is processed using a polynomial function to approximate a rectal temperature."
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. It mentions the "BTS App is based on well understood infrared measurement technology" and "The BTS App collects the temporal artery temperature, which is processed using a polynomial function to approximate a rectal temperature," suggesting the algorithm was developed and trained prior to this specific premarket notification, but details regarding its training are not provided in this summary.
9. How the Ground Truth for the Training Set Was Established
The document does not detail how the ground truth for the training set was established. It primarily focuses on the device's performance validation against a predicate and ISO standards. Given the use of a "polynomial function to approximate a rectal temperature," it's highly likely that the model was trained using paired temporal artery temperature readings and corresponding rectal temperature measurements as ground truth, but the specifics of this process are not included in this submission summary.
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