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The TempTouch® Dermal Thermometer is an infrared thermometer intended for the intermittent measurement of skin surface temperature of people of all ages.

The TempTouch® is a handheld, 9V battery-operated device that measures the surface temperature of the skin. Operation is based on measuring the natural thermal infrared radiation emitted from the surface of the skin.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Since performance testing confirms conformance to the same standard as the predicate device," which implies the acceptance criteria for each test was to meet the standards set by the predicate device (Omega Surface Temperature Scanner K873010 and Temp Touch Dermal Thermometer K050137) for each specific test. The exact numerical or descriptive acceptance criteria for each test are not explicitly detailed in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The document describes "Summary-Non-Clinical Performance Testing," suggesting laboratory-based assessments rather than clinical studies on human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable to the provided document. The tests performed are "Non-Clinical Performance Testing" (e.g., Accuracy, Repeatability), which typically rely on calibrated instruments and objective measurements rather than expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are non-clinical performance evaluations, there wouldn't be an adjudication method in the context of human expert review.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or reported in the provided document. The study focuses solely on the performance of the device itself, not on how human readers improve with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone study (algorithm/device only performance without human-in-the-loop) was done. The "Summary-Non-Clinical Performance Testing" directly assesses the device's accuracy, repeatability, and other functional aspects without human intervention in the measurement process.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance tests would be based on calibrated reference standards and objective physical measurements. For example:

• Accuracy: Comparison to a highly accurate reference thermometer.
• Repeatability: Statistical analysis of multiple measurements under controlled conditions.
• °F vs. °C tests: Verification against standard temperature conversion calculations.
• Variable Voltage Tests: Operating the device at different voltage levels and checking for correct function.

8. Sample Size for the Training Set

This information is not applicable. The TempTouch® Dermal Thermometer is described as a device that measures infrared radiation to determine skin surface temperature. There is no mention of a "training set" in the context of machine learning or AI. The device likely relies on pre-programmed algorithms and physical principles rather than being "trained" on data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reasons stated in point 8. The device's functionality is based on established physical principles of infrared thermometry, not on machine learning from a training set.

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