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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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