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The Infrared Forehead Thermometer (Model: T80、T81、T82、T83、T84、T85) is a non-contact thermometer used to measurement forehead temperature at home or hospital. The device is indicated for use on people of all ages except for neonates/newborns.

The Infrared Forehead Thermometer (Model: T80、T81、T84、T84、T85) 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 Forehead Thermometer (Model: T80、T81、T84、T85),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 and Backlight
f) 4 buttons (Setting button, Memory button, ON/OFF button, Measurement Trigger)
g) 2×1.5V AA dry batteries

The operation principle is based on Infrared Sensor technology. The sensor can turn body's temperature to analog signals, and a MCU with an AD can get the result by intelligent analyze and treat the analog signals.

The Infrared Forehead Thermometer (Models: T80, T81, T82, T83, T84, T85) has acceptance criteria primarily based on the ASTM E 1965-98 standard for infrared thermometers and ISO 80601-2-56 for clinical thermometers.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the referenced standards (ASTM E 1965-98, ISO 80601-2-56) and are demonstrated through performance tests.

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

• Sample Size: 150 subjects.
  • Divided into three age groups: Infants (less than 1 year), Children (1 to 5 years old), and Adults (greater than 5 years old).
  • No less than 50 subjects in each group.
  • 30% of the subjects had a temperature equaling or exceeding 37.5°C.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, "Clinical tests were conducted" and "The study excluded subjects..." indicate a prospective clinical trial involving human subjects.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth. It can be inferred that standard clinical temperature measurement methods (e.g., rectal or oral thermometry, depending on age group) were used as the reference standard against which the infrared forehead thermometer was compared, consistent with the requirements of ISO 80601-2-56 and ASTM E 1965.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method. Clinical accuracy studies for thermometers typically compare the device's readings directly against a trusted reference method, rather than requiring expert adjudication of the disease state itself.

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. The device is an Infrared Forehead Thermometer, which is a standalone medical device for temperature measurement, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

Yes, a standalone performance evaluation of the device was conducted. The clinical accuracy study evaluated the device's ability to measure temperature accurately directly against a reference standard, without human interpretation for diagnosis. The device itself is the "algorithm only" in the context of its function as a measurement instrument.

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

The ground truth for temperature measurement would be established by simultaneous measurements using a highly accurate and validated reference thermometer (e.g., a clinical reference thermometer, such as a rectal thermometer for infants, or an oral/tympanic thermometer for older children/adults, adhering to the requirements of the standards). The document refers to "clinical bias with stated uncertainty and clinical repeatability" evaluated against ISO 80601-2-56, which implies comparison to a reference standard for body temperature.

8. The sample size for the training set

The document only describes a clinical test set. No information about a separate "training set" is provided because this device is a physical measurement instrument, not a machine learning algorithm that requires a training set. The device's internal calibration and algorithms are developed during its engineering and manufacturing process, optimized through testing against known temperature sources, not through a "training set" in the AI sense.

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

Not applicable, as there is no training set in the context of an infrared thermometer as described in the document. The ground truth for the device's internal calibration would be established through highly accurate laboratory-grade temperature references.

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