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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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