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For T30: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1-3cm. The device can be used by consumers in homecare environment.

For TE-82: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the auditory canal. The device can be used by consumers in homecare environment.

For TE-102 and TE-79: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead. When measuring forehead temperature, it is non-contact and the distance of measurement is 3-5cm. The device can be used by consumers in homecare environment.

The Infrared Thermometer is a non-sterile, reusable device. Infrared thermometer are handheld, battery-powered devices designed to measure body temperature by receiving infrared energy radiation from the ears or forehead. When measuring forehead temperature, it is non-contact. The device can be used by consumers in homecare environment. There are four models. T30, which can measure body temperature by receiving infrared energy from the forehead or ear canal. TE-82 measure body temperature by receiving infrared radiation from the ears; TE-79 and TE-102 can measure body temperature by receiving infrared energy radiation from the forehead.

The thermometer has the result of measurement through the forehead temperature mode or ear temperature mode directly displayed on the LED or LCD display.

The results of measurements can also be transferred to the APP via Bluetooth for recording and display

The provided FDA 510(k) clearance letter and summary for K243082 details the acceptance criteria and the study that proves the device meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the Infrared Thermometer are derived from the performance standard ISO 80601-2-56 for clinical thermometers.

Note: The 510(k) summary only generally states compliance with ISO 80601-2-56 for clinical performance. It does not explicitly list the detailed accuracy limits from the standard (e.g., ±0.2°C within a certain range) and then report the device's measured accuracy against those specific limits in a direct table format within the provided text, but rather confirms overall compliance. The "Measuring accuracy" in the comparison table is for the device's technical specification, not necessarily a direct clinical accuracy result from the ISO 80601-2-56 study itself.

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

• Sample Size for Test Set: A minimum of 150 subjects.
• Data Provenance: The document does not explicitly state the country of origin. It also doesn't specify if the data was retrospective or prospective, though clinical performance testing as described ("The testing is conducted pre ISO 80601-2-56") usually implies prospective data collection for the purpose of demonstrating performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. For a thermometer, ground truth is typically established by comparative measurements against a highly accurate reference thermometer, rather than expert consensus on subjective interpretations.

4. Adjudication Method

This information is not applicable/provided as the ground truth for thermometer accuracy is established by a reference device, not by expert interpretation requiring adjudication.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret and classify images or data, often with and without AI assistance to measure the AI's impact on human performance. For a thermometer, the output is a direct numerical measurement, so this type of study is not applicable.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states:
"The testing is conducted pre ISO 80601-2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. This performance test consists of a minimum of 150 subjects... The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ISO 80601-2-56."

This clinical performance test on subjects directly evaluates the Infrared Thermometer (algorithm/device only) against a reference, thus constituting a standalone performance study.

7. Type of Ground Truth Used

The type of ground truth used is comparative measurement against a reference standard. While not explicitly stated, the ISO 80601-2-56 standard for clinical thermometers mandates comparison of the device's temperature readings against a highly accurate reference thermometer simultaneously or sequentially on human subjects.

8. Sample Size for the Training Set

The document does not provide information on a training set sample size. This device is an infrared thermometer, which typically relies on established physical principles (infrared radiation detection) and calibration rather than a machine learning model that requires a "training set" in the conventional sense of AI. Calibration and functional testing are usually performed at the manufacturing stage.

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

As noted above, a separate "training set" and associated ground truth establishment (in the AI/machine learning sense) are not applicable to this type of device according to the provided documentation. The device's accuracy is established through calibration and verified through clinical testing against a reference standard.

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