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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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The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.

Infrared Body Thermometer, model: HTD8222US, is a hand-held, battery powered, infrared thermometer that measures human body temperature through the opening of the auditory canal or on forehead, by measuring the infrared energy emitted in the area around the user's forehead or tympanic membrane and adjacent surfaces when placed within 1~5 centimeter of the subject's forehead or insert into auditory canal. The Infrared Body Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead or tympanic membrane and the adjacent surfaces for detection of non-contact use and contact use and compensation of the temperature reading.

The Infrared Body Thermometers measure temperature by pressing the On/Scan button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.

The device can measure temperature with three modes, forehead scan mode and ear mode.

Both forehead mode and forehead scan mode modes are non-contact with human body and measure forehead temperature. The forehead mode measures temperature from middle of the forehead, forehead scan mode measures temperature by scan the forehead from left to right or from right to left with position light spot following within approximately 3~10 seconds, then the maximum temperature will display on the screen.

The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. After removing the probe covering cap, the small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues emit IR radiation.

The provided text describes the acceptance criteria and the study conducted for the Infrared Body Thermometer, Model: HTD8222US.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: 140 subjects.
• Data Provenance: The document does not explicitly state the country of origin. It indicates that the clinical investigation report and data analysis followed the requirements of ASTM E1965-98 (2016). It also mentions that the submitter is based in DongGuan City, Guangdong, China. Given this information, it is highly probable the study was conducted retrospectively in China.

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

The document does not provide details on the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish the ground truth for the clinical accuracy testing. It only states that the "clinical investigation report and data analysis followed the requirements of the ASTM E 1965-98 (2016)."

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth for the test set.

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. The study focuses on the standalone performance of the infrared thermometer and its comparison to standards, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance study was done. The document describes the clinical accuracy testing of the device itself (Infrared Body Thermometer, Model: HTD8222US) in various modes (forehead, forehead scan, ear) against the requirements of ASTM E1965-98 (2016). This evaluates the algorithm's performance in taking temperature measurements.

7. The Type of Ground Truth Used:

The ground truth for the clinical accuracy testing was established based on the requirements of ASTM E1965-98 (2016), which is a standard specification for infrared thermometers for intermittent determination of patient temperature. This implies a comparison to a reference temperature measurement method, likely a highly accurate clinical thermometer, to determine the bias and repeatability of the device.

8. The Sample Size for the Training Set:

The document does not specify a separate "training set" or its sample size. The description of clinical accuracy testing refers to a "test set" of 140 subjects. For medical devices like thermometers, it is common for the "training" (calibration and development) to be conducted internally by the manufacturer, and the regulatory filing focuses on the validation (test) phase.

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

As no specific training set is mentioned, the method for establishing ground truth for a training set is not detailed in the provided information. However, the overall development and calibration of such a device would likely follow internal standards and involve rigorous testing against known temperature sources and potentially clinical reference thermometers to ensure accuracy and precision.

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The Infrared Body Thermometer, Model: HTD8216C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead or auditory canal in people of all ages for home setting use.

Infrared Body Thermometer, model: HTD8216C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the central forehead or auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the central forehead or tympanic membrane.

The forehead mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the central forehead skin. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor.

The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal.

To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.

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

Device: Infrared Body Thermometer, Model: HTD8216C

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document states that the clinical investigation report and data analysis followed the requirements of ASTM E 1965-98 and ISO 80601-2-56. These standards typically specify patient cohorts and measurements for clinical accuracy testing. However, the exact sample size for the test set is not explicitly stated in the provided text. It only mentions "three group's temperature readings difference".
• Data Provenance: Not explicitly stated. The document is from a Chinese company (HeTaiDa Technology Co., Ltd. in Guangdong, China) and was submitted to the FDA. It does not clarify if the clinical study was conducted in China, the US, or elsewhere, nor whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The study compares the device's readings to a "digital thermometer" (referred to as the "ground truth" or reference, typically a rectal or oral thermometer), but does not mention experts establishing a ground truth for individual cases. For clinical thermometer accuracy, the ground truth is usually established by a validated reference thermometer.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• None explicitly mentioned. For clinical accuracy studies of thermometers, an adjudication method for human interpretation is not typically required, as the ground truth is a direct temperature measurement from a reference device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is an infrared body thermometer, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, this is essentially a standalone device performance study. The device itself measures and displays temperature. The clinical study evaluated the accuracy of the device's measurements relative to a reference (digital thermometer) without directly involving a human-in-the-loop for interpretation of the device's output.

7. The type of ground truth used:

• Clinical temperature measurements from a reference device. The "digital thermometer" serves as the ground truth for comparison. This implies a standard clinical measurement method that is widely accepted for accuracy.

8. The sample size for the training set:

• This information is not provided as there is no mention of a "training set" in the context of this device. Thermometers are typically calibrated during manufacturing and their accuracy is demonstrated through performance testing against established standards, rather than machine learning training.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set mentioned for this device.

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