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Non Contact Infrared Forehead Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.

The thermometer measures the temperatures of people by detecting the energy. The external probe plays an important role in the measuring process. As soon as the thermometer is placed near the body and the radiation sensor is activated, the measurement will be taken instantly by detection of the infrared heat. The thermometer includes two models: TVT-200, TVT-200 PLUS. The TVT-200 model includes four colors: pink, grey, orange and purple. While TVT-200 PLUS has only orange color. The Non Contact Infrared Forehead Thermometer is composed by an IR sensor, a Human temperature measurement button, an object temperature button, Battery compartment, Buzzer, °C /°F button, a LCD and an enclosure. The functions of TVT-200 and TVT-200 PLUS are the same, except the Back Light.

The provided text describes the acceptance criteria and the study conducted for the Non Contact Infrared Forehead Thermometer (Models: TVT-200, TVT-200 PLUS).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the standards the device claims to meet, specifically ASTM E1965-98 (2009) and ISO 80601-2-56: 2009. The reported device performance indicates that the device passed all tests against these standards.

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

The document states:

• Sample Size: Not explicitly mentioned in terms of number of subjects or measurements. It only states that the "[c]linical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2009)." This standard typically specifies requirements for clinical accuracy testing, which involves a certain number of subjects and repeated measurements.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, clinical accuracy tests for medical devices are generally prospective.

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

This information is not provided in the document. For a thermometer, "ground truth" for temperature is typically established by reference thermometers (e.g., rectal or oral thermometers) measured by trained personnel, not necessarily by "experts" in the sense of radiologists.

4. Adjudication Method 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 not applicable to this device. The device is a non-contact infrared thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that aids human readers.

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

Yes, a standalone performance assessment was done. The entire testing listed under "Nonclinical tests" and "Clinical accuracy" (bench performance, clinical accuracy) evaluates the device's performance without human interpretation or intervention in the temperature measurement itself. The device is intended for direct measurement.

7. The Type of Ground Truth Used

For the clinical accuracy testing, based on the reference to ASTM E1965-98 (2009), the ground truth would be measurements from a clinically accepted reference thermometer (e.g., a rectal or oral thermometer whose accuracy is established) taken concurrently with the non-contact forehead thermometer.

8. The Sample Size for the Training Set

This information is not applicable. The device is an infrared thermometer, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its physical design and calibration, which are verified through the outlined tests.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as in point 8.

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