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The Infrared Thermometer (Model: IR8807) is intended for the intermittent measurement of human body temperature from the forehead. It is a non-contact clinical thermometer and intended for use on people of all ages except for neonates/newborns.

The Infrared Thermometer (Model: IR8807) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The Infrared Thermometer (Model: IR8807) has a forehead measurement mode and an object measurement mode.

The Infrared Thermometer (Model: IR8807), consists of the following parts:
a) Thermopile Sensor
b) Application-Specific Integrated Circuitry
c) Erasable Programmable Read-Only Memory Integrated Circuit
d) Capacitance-touch Integrated Circuit
e) LCD display
f) 2 buttons (Scan button, Setting button,)
q) 2×1.5V AAA dry batteries

The operation principle is based on infrared sensor technology. The sensor in the thermometer detects the infrared energy, and the device processes the data to body temperature result with its internal microcontroller unit. It operates in an adjusted mode.

The main functions of Infrared Thermometer (Model: IR8807) are as followings:
Forehead temperature measure functions
Wide range of temperature readings: from 32.0ºCto 42.9ºC (89.6ºF ~ 109.2ºF)
The measurement results can be displayed in either °Cor °F units
The LCD display showing clear measurement result.
Memory data reading/removal function: The device can store a total of 32 groups of memorable values. All memory values can be removed after the battery is removed
Low battery indicator
Buzzer reminder function
Users can set temperature alarm value
Environment or object temperature measurement function
The reference body site of the output temperature is Oral.

The provided document describes the Infrared Thermometer, Model: IR8807, and its compliance with relevant standards and performance criteria. Here's a breakdown of the requested information based on the text:

1. A table of acceptance criteria and the reported device performance

Note: The document states that the device's accuracy requirements meet ASTM E1965-98. The specific ASTM E1965-98 requirements for measurement range, accuracy, measurement time, and measurement distance are not explicitly detailed in the provided text beyond what's shown for the device's performance. The table above uses the device's reported performance as the "reported device performance" and implies these meet the ASTM E 1965-98 criteria because the document explicitly states compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for clinical test set: 169 subjects.
• Data Provenance: The document does not specify the country of origin. The test was a "clinical test" which implies a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document only mentions "clinical tests were conducted" and that the "clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016)." It does not describe the method or personnel used to establish the ground truth (reference temperature).

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

This information is not provided in the document.

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 an Infrared Thermometer. The document describes clinical tests for device accuracy, not a comparative effectiveness study involving human readers or AI assistance. Therefore, no MRMC comparative effectiveness study was done in the context of human readers improving with or without AI.

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

Yes, a standalone performance study was done for the device. The "clinical tests" described in section 8 were conducted on the Infrared Thermometer (Model: IR8807) itself, evaluating its direct measurement performance against a ground truth (implied by compliance with ASTM E1965-98 for clinical accuracy). This assesses the algorithm/device's performance without human interpretation or intervention in the measurement process beyond standard use.

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

The document does not explicitly state the type of ground truth used. However, given that it's a clinical thermometer study and states compliance with ASTM E1965-98, the ground truth would most likely be a reference clinical thermometer (e.g., a highly accurate rectal, oral, or tympanic thermometer, depending on the standard's protocol for correlating to forehead temperature) used simultaneously or sequentially with the test device.

8. The sample size for the training set

This device is a physical thermometer, not an AI/ML model that typically requires a "training set." The concept of a training set is not applicable to this device.

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

As the concept of a training set is not applicable to this device, this question is not relevant.

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The Digital Thermometer QT001 is intended to measure the human body temperature in armpit, orally or rectally, and the device is reusable for clinical or home use on people of all ages.

The digital thermometer QT001 is hand held device which can measure human body's temperature at the site of armpit, orally or rectally, the device is reusable for clinical or home use on people of all ages. The results can be displayed on LCD. The QT001 has only one operating mode: direct mode. The digital thermometer measures temperatures of human body by placing the probe tip into the armpit, oral, rectum directly with the measuring time about 3 minutes. The digital thermometer consists of a temperature sensor, low power consumption integrated circuit(IC),LCD display and buzzer. The resistance of sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD. The thermistor sensor(Type:503F) reacts to temperature. In different temperature, the thermistor has a different resistance value. The essence of temperature measurement is actually measuring the resistance of the sensor, usually is to change the resistance into voltage or current and other analog signals, and digital signals, and then the processor converts the signals to the corresponding temperatures. QT001 has several functions, such as beep alarm, unit switchable, low battery detection, memories, backlight, auto power off functions.

Here's a breakdown of the acceptance criteria and study information for the Digital Thermometer (Model QT001), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "performance testing shows the subject device complies with standard ISO 80601-2-56," and "performance test was conducted in accordance with ISO 80601-2-56." and "software verification and validation were conducted". These standards, particularly ASTM E1112:00 and ISO 80601-2-56, define methodologies and requirements for testing clinical thermometers, which would inherently involve a test set of measurements. However, the specific number of subjects, measurements, or the origin of this data is not detailed in this summary.

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

This information is not provided in the document. For a clinical thermometer, the "ground truth" for temperature measurements would typically be established by highly accurate reference thermometers or methods in a controlled laboratory setting, rather than human experts in the way AI/radiology studies utilize them.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment. For a device like a digital thermometer measuring a physical parameter against a standard, the "adjudication" is inherent in the comparison to the reference standard's reading and the pass/fail criteria of the specified accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and reader variability, such as medical imaging AI. The Digital Thermometer is a standalone measurement device; its performance is not evaluated in terms of how it "improves" human reader performance.

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

Yes, a standalone study was done. The entire "Test Summary" section describes the non-clinical tests conducted on the Digital Thermometer (Model QT001) to demonstrate its compliance with various international standards (ASTM E1112-00, IEC 60601-1, ISO 80601-2-56, etc.). This inherently means the device's performance was evaluated independently without human intervention influencing its measurement accuracy.

7. The Type of Ground Truth Used:

The ground truth used for calibration and accuracy verification is the readings from highly accurate reference thermometers or validated temperature sources that meet the requirements of the specified standards (e.g., ASTM E1112-00, ISO 80601-2-56). These standards outline the methods for generating and comparing measurements against known, precise temperatures.

8. The Sample Size for the Training Set:

The document does not mention a training set in the context of machine learning or AI models. This device is a traditional digital thermometer based on a thermistor and embedded firmware for calculation, not a machine learning algorithm that requires a "training set."

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

As there is no mention of a machine learning model or a training set, the establishment of ground truth for a training set is not applicable to this device described in the submission. The device's functionality relies on established physics and pre-programmed algorithms, not learned patterns from data.

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