(140 days)
The Electronic Thermometers are intended to measure the human body temperature under arm, and the devices are nonsterile, reusable for clinical or home use on people of all ages.
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F334, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
I'm sorry, but this document does not contain the information required to answer your request. The provided text is an FDA 510(k) clearance letter for an electronic thermometer. It details regulatory information, product codes, indications for use, and compliance requirements. However, it does not include any details about:
- Acceptance criteria and reported device performance related to a study. The document lists the device models and their intended use (measuring human body temperature under the arm), but no specific performance metrics or thresholds are mentioned.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance data.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of information, particularly regarding studies, performance data, and ground truth establishment, is typically found in the 510(k) submission itself (which often includes a "Truth in Labeling" section or performance testing reports), but it is not presented in the FDA's clearance letter.
§ 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.