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The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.

The Infrared Thermometer, Model MD-H30 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display.

The provided text is related to the FDA 510(k) premarket notification for an Infrared Thermometer (Model MD-H30). This document focuses on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device, rather than providing a detailed clinical study report with the typical elements of acceptance criteria and performance data for an AI/ML medical device.

Key takeaway: This document describes a medical thermometer, not an AI/ML device. Therefore, many of the questions regarding AI/ML specific criteria (e.g., training set, expert adjudication, MRMC study, standalone performance) are not applicable to the information contained here.

However, I can extract the relevant information concerning the device's accuracy and the validation study performed:

Acceptance Criteria and Reported Device Performance

Given that this is a non-AI/ML device (an infrared thermometer), the "acceptance criteria" primarily revolve around its stated accuracy specifications and compliance with relevant performance standards for thermometers.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Focusing on a non-AI/ML device)

1. Sample size used for the test set and the data provenance:

   • The document states, "The clinical investigation report and data analysis met the requirements of the ASTM E 1965-98."
   • It mentions "the three group's temperature readings." However, the exact sample size (number of subjects or measurements) for this clinical accuracy validation is not provided in the submitted text.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information would typically be in the full clinical study report, which is not provided here. The manufacturer is based in China, so it's plausible the study was conducted there.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of an infrared thermometer. Ground truth for temperature measurement would be established by a reference thermometer or standard. The document mentions comparison to a "digital thermometer."

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

   • Not applicable as this is a device for direct physical measurement, not an interpretative AI/ML system.

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:

   • Not applicable. This is not an AI-assisted device.

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

   • Not applicable. This is a standalone physical device. Its performance is its direct measurement output.

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

   • The ground truth for the clinical accuracy validation was established by comparison to a "digital thermometer." For thermometer validation, this typically refers to a highly accurate reference thermometer, often using a controlled environment or comparing against an established method (e.g., rectal temperature for core body temperature, depending on the standard).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable.

In summary, the provided document is a 510(k) summary for an infrared thermometer, focusing on its substantial equivalence to a predicate device based on its design, intended use, and performance against established non-clinical and clinical (accuracy) standards for medical thermometers. It does not contain the detailed information typically found in a clinical study report for an AI/ML-driven medical device.

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