(79 days)
For intermittent measurement of body temperature in patients of all ages in home environment
Not Found
The provided document is a 510(k) clearance letter from the FDA for a clinical electronic thermometer. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the format requested.
The document states that the device is a "NPAC Multi-Use Ear Thermometer, Models TP 700, TP 702" and its indications for use are "For intermittent measurement of body temperature in patients of all ages in home environment."
To answer the questions about acceptance criteria and a study, one would typically need access to the 510(k) submission document itself, which would detail the performance data and the comparison to a predicate device. This letter only confirms that the device has been found substantially equivalent to a legally marketed predicate device.
Therefore, none of the requested information (acceptance criteria table, sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set size, or ground truth establishment for training set) can be extracted from the provided text.
§ 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.