(316 days)
The Infrared Thermometer (model of AET-R612W.AET-R612G.AET-R612A.AET-R612B.AET-R612C) is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from ear canal or non-contact (about 1.5-5.0cm distances) with the forehead in the home or hospital environment.
Not Found
The provided document is an FDA 510(k) clearance letter for an infrared thermometer. It outlines the regulatory approval for marketing the device. However, it does not contain the detailed technical study information typically found in a clinical study report or a 510(k) summary submission that would include acceptance criteria and a description of the study proving the device meets those criteria.
Therefore,Based on the provided text, I cannot provide the information requested regarding:
- A table of acceptance criteria and the reported device performance: This document only states the device is "substantially equivalent" to predicate devices, but does not present specific performance metrics or acceptance criteria.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not applicable for a thermometer.
- If a standalone performance was done: Not explicitly detailed, but implied by the device's function. No specific performance data is provided.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable as this is a physical device, not an AI/ML algorithm requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory communication, not a technical report detailing the performance validation study. For such information, one would typically look for a 510(k) Summary, which is often available through the FDA's public database after a device is cleared, or a detailed technical file submitted to the FDA by the manufacturer.
§ 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.