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INFRARED BODY THERMOMETER (Model: YK-001) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature using the center of the forehead as the measurement site. The device is indicated for use by people over one month old. It can be used by consumers in household environment and doctors in clinic as reference.

The proposed device, INFRARED BODY THERMOMETER, which includes model YK-001 hand-held, reusable, battery powered device, which is intended to detect body temperature from forehead. The proposed device measure temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The distance of the measurement is 3cm~5cm. The proposed device uses a temperature sensor, which can detect the human forehead temperature, object temperature and environment temperature; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display. The device has the following features: About two-second measuring time, measuring Body or Ambient temperature, 99-memory recalls, degree C/degree F unit switchable, over range message (Hi/Lo), low battery indication, auto shut-off when the device is idle for 15 seconds. When completes, the results will be displayed on the LCD display screen. The device will display 3 different background colors according to the result.

The power supply of INFRARED BODY THERMOMETER (YK-001) is 3.0V DC, it is powered by two AAA batteries.

The reference body site of INFRARED BODY THERMOMETER (Model: YK-001) is armpit.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is an Infrared Body Thermometer. The primary acceptance criteria for such a device are related to its accuracy in measuring body temperature. The text explicitly mentions compliance with ISO 80601-2-56:2017 and ASTM E 1965-98 (2016) for performance.

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

• Sample Size: 137 subjects were used for the clinical accuracy study.
• Data Provenance: The document does not explicitly state the country of origin. The study is described as a "clinical accuracy study" indicating it was a prospective study where measurements were taken on human subjects. The fact that the manufacturer is in China and the application correspondent is SGS-CSTC in Guangzhou, China, suggests the study was likely conducted in China.

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

The document does not provide this information. For a clinical thermometer, the "ground truth" would typically be established by simultaneous measurement with a highly accurate reference thermometer (e.g., a rectal thermometer or a hospital-grade electronic thermometer with known calibration) under medical supervision, rather than by human "experts" evaluating the device's output.

4. Adjudication Method for the Test Set

The document does not provide this information. As mentioned above, for a thermometer's accuracy study, the ground truth is typically a direct reference measurement, not a subjective interpretation requiring adjudication of multiple readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human interpretation plays a significant role. This device is a direct measurement tool (a thermometer).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence, the "clinical accuracy study" describes the standalone performance of the device. The study evaluated the thermometer's ability to accurately measure body temperature on its own, comparable to a reference standard, without human interpretation of the device's output being the variable under test. The output displayed on the LCD is the device's determination.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy study would have been established by comparing the device's measurements to a reference standard body temperature measurement (e.g., a calibrated reference thermometer, likely a rectal thermometer or other highly accurate clinical thermometer). The text states "The clinical test results showed that the accuracy of the proposed device is within acceptable scope specified in ISO 81061-2-56," and specifies accuracy ranges. This implies a comparison to a known accurate measurement.

8. The Sample Size for the Training Set

The document does not mention a training set. This is a medical device that performs a direct measurement, not an AI/Machine Learning diagnostic algorithm that requires a training set. Therefore, this information is not applicable.

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

Not applicable, as there is no training set for this type of device.

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