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The Clever TD-1112 ear/skin/surface IR thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.

The Clever TD-1112 ear/skin/surface IR thermometer is an electronic thermometer using an infrared sensor.

The provided text is a 510(k) clearance letter from the FDA for the "Clever TD-1112 Ear/Skin/Surface IR Thermometer". It states that the device is substantially equivalent to a legally marketed predicate device.

However, the document does not contain the detailed information requested regarding acceptance criteria, specific study results, sample sizes, expert qualifications, ground truth establishment, or AI-related metrics. These details are typically found in the 510(k) submission summary or actual testing reports, which are not included in this letter.

Therefore, I cannot provide the requested information based solely on the provided text. The letter primarily focuses on the FDA's determination of substantial equivalence and regulatory compliance, not the specifics of the performance study itself.

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