(151 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) 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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical accuracy criteria in conformance with ISO 80601-2-56:2017 (for clinical bias and Limits of Agreement). | Clinical Bias: +0.04°C (calculated using the mean of three comparator device readings). |
| Limits of Agreement (LOA): Lower LOA: -0.94°C (-1.09°C, -0.78°C 95% CI); Upper LOA: 1.02°C (0.85°C, 1.18°C 95% CI). | |
| Accuracy Range: Within the stated temperature range of 36°C and 40°C. | |
| Bench Testing (Non-clinical performance testing): Demonstrate the ability of the device to detect adequate signal quality under anticipated conditions of use. Testing must evaluate: |
- 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
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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
- Sample Size: 145 racially and ethnically diverse subjects were enrolled, 144 completed the study.
- Clinical Study Test Set:
N/A