Search Results

The TaiDoc TD11 series Ear/Skin/Surface IR Thermometers, Clever TD-1112 Ear/Skin/Surface IR Thermometer, FORA IR16/17 Ear Thermometers are 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.

electronic thermometer using an infrared sensor

This document is a 510(k) premarket notification acceptance letter from the FDA for several infrared thermometers. It does not contain any information about acceptance criteria for device performance, nor does it describe any study results.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to predicate devices, not on the technical performance of the devices against specific criteria or the details of any studies proving that performance.

Ask a specific question about this device

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.

Ask a specific question about this device