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The Non-Contact Forehead Thermometer (Model:UT306H, UT308H) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.

The Non-Contact Forehead Thermometer (Model:UT306H, UT308H) is a hand-held, nonsterile, reusable, battery powered device designed to measure human body temperature wa body sites: the skin of the forehead.

The Infrared Forehead Thermometer is a battery powered, infrared Thermometer that converts a user's forehead temperature, using the infrared energy emitted from the area around the user's forehead, to an oral equivalent temperature when placed within 1-5 cm to the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for ambient temperature readings.

lt is composed by a measuring sensor, set buttons, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover.

The power supply of the thermometer are 3.0V DC, it is supplied by two AA batteries.

The main functions of Non-Contact Forehead Thermometer are as follows:

• Forehead measurement functions
• Wide range of temperature readings: from 32.0℃ to 45.0℃ (89.6℃ -113.0℃ )
• The big LCD display showing clear measurement results.
• Memory function
• Low battery indicator

The provided text describes the clinical validation of a non-contact forehead thermometer. While it doesn't detail a study involving AI-assisted human readers or complex image analysis, it does describe the acceptance criteria and the study conducted to prove the device's performance.

Here's an analysis of the provided information, framed by your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Non-Contact Forehead Thermometer are primarily defined by adherence to international standards for clinical thermometers, specifically ISO 80601-2-56 and ASTM E 1965.

Study Details:

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

   • Sample Size: 150 subjects.
   • Data Provenance: The document does not specify the country of origin. It does state that the study was a "clinical accuracy study" and doesn't explicitly mention "retrospective" or "prospective," but the description of subject enrollment ("three groups of subjects being tested") and data collection ("150 data sets were collected") strongly suggests a prospective study.

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

   • The document does not specify the number or qualifications of experts used to establish the "ground truth" (i.e., reference temperature measurements). For thermometer accuracy studies, ground truth is typically established using a highly accurate reference thermometer (e.g., rectal thermometer or equivalent) operated by trained medical personnel.

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

   • The document does not describe an adjudication method. For a thermometer study, "adjudication" in the sense of expert consensus on image interpretation is not directly applicable. The ground truth is a direct physiological measurement.

4. 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:

   • No, an MRMC comparative effectiveness study was not conducted. This device is a standalone thermometer, not an AI diagnostic tool requiring human reader assistance for interpretation.

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

   • Yes, the clinical accuracy study described is a standalone performance test of the device. The device itself performs the measurement and provides a reading; there's no human "interpretation" of the device's output that would be assisted by an AI. The study's aim was to determine if the device's measurements themselves were accurate compared to a reference.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth was established by comparison to a reference method for body temperature measurement, implied by the context of "clinical accuracy study" and adherence to ISO 80601-2-56. While not explicitly stated, this usually involves simultaneous measurement with a highly accurate clinical thermometer (e.g., standard rectal or oral thermometer used as a reference) and comparing the device's reading to that reference.

7. The sample size for the training set:

   • This document describes a clinical validation study for a medical device (thermometer), not an AI model. Therefore, there is no "training set" in the context of machine learning. The device's algorithms for temperature calculation are pre-programmed based on physics and calibration, not learned from data.

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

   • As there is no training set mentioned in the context of an AI model, this question is not applicable. The device's internal calibration and temperature calculation methods are validated against physical standards and clinical data.

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The Non-Contact Forehead Thermometer (Model: UT30H) is a reusable, infrared thermometer intended for the intermittent measurement of human body temperature on the forehead of people of all ages. It can be used by consumers in the home environment and doctors in the clinic environment as reference.

The Non-Contact Forehead Thermometer (Model: UT30H) is a hand-held, non-sterile, reusable, batteny powered device designed to measure human body temperature wa body sites: the skin of the forehead.

The Infrared Forehead Thermometer is a battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted from the area around the user's forehead, to an oral equivalent temperature when placed within 1-5 cm to the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for ambient temperature readings.

It composed by a measuring sensor, set buttons, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover.

The power supply of the thermometer are 3.0V DC, it is supplied by two A AA batteries.

The main functions of Non-Contact Forehead Thermometer are as followings:

• Forehead measure function
• Wide range of temperature readings: from 32.0℃ to 45.0℃(89.6℃ -113.0℃))
• The big LCD display showing clear measure result.
• Low battery indicator

The provided text describes the 510(k) summary for the "Non-Contact Forehead Thermometer (UT30H)" and includes information about its acceptance criteria and the study conducted.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Non-Contact Forehead Thermometer (UT30H) are primarily based on international standards for clinical thermometers. The reported device performance is stated to be compliant with these standards.

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

• Sample Size for Test Set: 150 subjects.
• Data Provenance: Not explicitly stated regarding country of origin. The study was a "clinical accuracy study" and did not specify if it was retrospective or prospective, but the phrasing "were performed to determine the clinical accuracy" suggests a prospective clinical study.

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. For a non-contact thermometer, ground truth would typically be established by a reference thermometer (e.g., orally, rectally, or invasively) rather than expert consensus on individual readings.

4. Adjudication method for the test set

This information is not provided in the document. Given the nature of a clinical thermometer accuracy study, an adjudication method for individual readings is typically not relevant. The assessment would involve comparing the device's readings against a reference method.

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

This is not applicable as the device is a non-contact thermometer, not an AI-assisted diagnostic tool that involves human readers or interpretation of complex medical cases.

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

This is not applicable as the device is a physical thermometer measuring temperature, not an algorithm, and it always involves a human user to operate it. The "standalone" performance here refers to the device's inherent accuracy, which was indeed evaluated.

7. The type of ground truth used

The ground truth used for the clinical accuracy study was presumably a reference body temperature measurement obtained through a validated clinical method (e.g., oral, rectal, or potentially tympanic/temporal, though not specified) against which the non-contact forehead thermometer's readings were compared. The text mentions the device converts to an "oral equivalent temperature," implying a comparison to oral temperature as a ground truth or a gold standard.

8. The sample size for the training set

This information is not applicable or not provided. Clinical thermometers are typically hardware-based devices with embedded algorithms, not machine learning models that require a separate "training set" in the conventional sense. Their calibration and internal algorithms are developed during manufacturing and validated through performance testing rather than a separate training phase.

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

This is not applicable for the reasons stated in point 8.

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The Non-contact Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch mode on the centre of the forehead as the measurement site on people of all ages.

The Non-contact Forehead Thermometer (Model TH1009N) is a hand-held, battery powered device designed to measure human body temperature. The TH1009N is a kind of medical device that utilize infrared radiation to measure body temperature. The Non-contact Forehead Thermometer is intended to measure forehead temperature.

The Non-contact Forehead 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, and an infrared distance sensor for detection of contact or non-contact (at a distance of approximately 0-5cm) use and compensation of the temperature reading.

The provided document is a 510(k) Summary for a Non-contact Forehead Thermometer (Model TH1009N). Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the information provided:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated for the clinical evaluation. The document mentions a "clinical evaluation..." conducted in compliance with ASTM E1965-98. ASTM E1965-98 specifies the clinical accuracy requirements for infrared thermometers (e.g., in Section 8), which typically involves a minimum number of subjects (e.g., 50 subjects for clinical accuracy studies, as per older versions of similar standards, but the exact number isn't in this document).
• Data Provenance: The "Clinical evaluation of Non-contact Forehead Thermometer was conducted by Shenzhen Dongdixin Technology Co., Ltd". This implies the study was conducted by the manufacturer, likely in China. The document does not specify if the data was retrospective or prospective, but clinical evaluations are typically 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. For thermometer accuracy, "ground truth" is typically established by comparing the device reading against a highly accurate reference thermometer (e.g., an oral or rectal thermometer with known accuracy, or a blackbody simulator), rather than expert interpretation.

4. Adjudication method for the test set

• This information is not applicable and therefore not provided, as the ground truth for thermometer accuracy is typically a direct measurement from a reference device, not an interpretation requiring adjudication.

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

• This is not applicable. This device is a non-contact forehead thermometer, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

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

• This is not applicable in the context of "algorithm only" performance as commonly discussed for AI/ML devices. The device itself is standalone in that it provides a temperature reading without human interpretation for the result. Its "performance" is its accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the clinical evaluation, the ground truth would be established by measurements from a highly accurate reference clinical thermometer (e.g., an oral or rectal thermometer) as specified by the ASTM E1965-98 standard. The document states the clinical evaluation was in compliance with this standard.

8. The sample size for the training set

• This information is not applicable and therefore not provided. The device described does not appear to involve machine learning or AI that would require a "training set" in the conventional sense. Its function is based on infrared sensing and internal algorithms, not on learning from a large dataset.

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

• This information is not applicable as there is no mention of a training set for machine learning or AI algorithms within the provided documentation.

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