(434 days)
The Infrared Thermometer is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from non-contact (about 1.5-5.0cm distances) with the forehead in the home or hospital environment.
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I am sorry, but the provided text from the FDA 510(k) clearance letter for the Alicn Medical Shenzhen, Inc. Infrared Thermometer (K210565) does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets them.
The letter focuses on the FDA's determination of substantial equivalence to a predicate device, the applicable regulations, and administrative instructions. It does not include:
- A table of acceptance criteria and reported device performance.
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- Information on MRMC studies or effect sizes.
To obtain this information, you would typically need to refer to the Premarket Notification (510(k)) Summary or the Device Description document submitted by the manufacturer to the FDA, which are sometimes publicly available through the FDA's 510(k) database if the manufacturer chooses to make them so, or if they are released under a Freedom of Information Act (FOIA) request.
The provided document is merely the FDA's clearance letter, not the underlying test reports or summary data.
§ 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.