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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

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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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) is a mobile medical application available to its intended users via their mobile device. The Body Temperature Software (BTS) collects and analyzes temperature data obtained via the infrared sensor built into the smartphone to approximate the user's rectal temperature which is then displayed on the application's user interface. The Body Temperature Software (BTS) is a pre-installed application on the Pixel 8 Pro with Android 14 operating system release or higher.

Here's a breakdown of the acceptance criteria and the study information for the Body Temperature Software (BTS), based on the provided text:

Acceptance Criteria and Device Performance

• The laboratory accuracy of the device across the intended output range under the intended operating conditions.
• The impact of confounding factors on device accuracy. | Range Check Flag: Correctly captures distance and gates forehead temperature measurement signals within a specified range. |
  | | Infrared Sensor Internal (Ambient) Temperature (TA) Check Flag: Sufficiently and correctly measures internal and sensor window temperature and gates forehead temperature within a specified range. |
  | | Robustness to External Aggressors: Variations in inputs due to motion artifacts, environment, and wear condition/position do not significantly affect algorithm performance. |
  | | Fitzpatrick/Monk Level Performance: Infrared sensor signal quality does not vary significantly across various skin tones, and skin tone emissivity does not impact algorithm performance. |
  | | Hardware Equivalency: Variations of hardware and software components on compatible Pixel mobile devices have no significant effect on signal quality. |
  | | Skin Temperature Range Check: Filtered maximum forehead temperature is in the range of 30°C to 40°C. |
  | | Body Temperature Check: Calculated maximum temperature is in the range of 34.5°C to 43°C. |
  | | Window & Sensor Temperature Differences Check: Sensor-to-sensor window temperature difference is ≤ 2°C. |
  | Software verification, validation, and hazard analysis | The Body Temperature Software has a Moderate Level of Concern (LOC). Appropriate documentation was provided to support the validation of the software for a Moderate LOC in accordance with FDA's 2005 guidance. |
  | Usability and Human Factors | Usability testing demonstrated that the Body Temperature Software (BTS) is safe and effective for the intended users, uses, and use environments. |

Study Details

1. Sample size used for the test set and the data provenance:

   • Clinical Study Test Set:
     • Sample Size: 145 racially and ethnically diverse subjects were enrolled, 144 completed the study.
       • 37 newborns and infants (0 to

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