(153 days)
The Infrared thermometer is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear canal or by the center of forehead(non-contact type) for people of all ages.
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The provided text concerns the FDA 510(k) clearance for an "Infrared thermometer" (K221211). It does not describe:
- Acceptance criteria for an AI/ML device. This document is for a physical medical device (an infrared thermometer), not a software or AI-driven diagnostic tool.
- A study proving the device meets acceptance criteria. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance, rather than detailing a specific performance study against defined acceptance criteria.
Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving an AI/ML device meets them, as this document is not about such a device or study.
The request specifically asks for information related to AI/ML device studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance). This information is entirely absent for a simple infrared thermometer.
§ 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.