(11 days)
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.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.