(557 days)
The Phoenix Digital Thermometer is intended to measure the human body temperature orally, rectally or under the arm. The Phoenix Digital Thermometer is reusable for clinical or home use on people of all ages.
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This document appears to be an FDA 510(k) clearance letter for a "Phoenix Digital Thermometer." As such, it grants market clearance based on substantial equivalence to a predicate device, but it does not contain the detailed acceptance criteria for device performance or the study details proving it meets those criteria, as typically found in a clinical study report or a more extensive submission summary.
The letter confirms the device is substantially equivalent to legally marketed predicate devices and is subject to general controls, but it does not describe a specific study proving the device meets particular acceptance criteria in the way you've outlined.
Therefore, I cannot provide the requested information in the structured format you've asked for based solely on the provided text. The document acts as an approval notice, not the validation study itself.
To answer your questions, I would need access to the actual 510(k) submission summary or supporting documentation that was reviewed by the FDA, which would detail the performance data, acceptance criteria, and study design used to demonstrate substantial equivalence.
§ 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.