(17 days)
The device measures the body temperature of a patient by means of a sensor (transducer) coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Digital Clinical Thermometer, Models ST8C Series
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a Digital Clinical Thermometer. It does not contain information about acceptance criteria for a device's performance, a study proving it meets those criteria, or any details related to AI algorithms, ground truth, expert reviews, or sample sizes for testing or training sets.
Therefore, I cannot provide the requested information based on the input. The document merely states that the device is substantially equivalent to legally marketed predicate devices.
§ 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.