(14 days)
The Digital Clinical thermometers, Models ACT 2030 and ACT 2038's intended use are medical devices, supplied by internal power and intended to precisely measure temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.
Digital Clinical Thermometers, Models ACT 2030, ACT 2038
The provided text is a 510(k) clearance letter from the FDA for Digital Clinical Thermometers. It does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.
Therefore, I cannot provide the requested information based on the input text. The request asks for details of a study that proves the device meets acceptance criteria, but no such study details are present in the provided document.
To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive 510(k) submission document that includes performance 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.