(217 days)
VisioFocus 06400, 06450, 06480 and 06490 series are infrared thermometers intended for intermittent measurement of human body temperature in people of all ages.
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This document is a 510(k) clearance letter for a medical device, the VisioFocus infrared thermometer. It primarily focuses on regulatory approval rather than providing detailed study results that would typically include comprehensive acceptance criteria and performance data.
Therefore, the requested information, particularly detailed acceptance criteria and a study proving the device meets them with specific metrics (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness), is not present in the provided text.
The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This equivalence is based on the provided indications for use and other unspecified information in the 510(k) submission.
Without the actual 510(k) submission document, which would contain the detailed performance testing, it's impossible to completely fill out the requested table and answer all questions definitively.
Here's what can be inferred or stated based on the provided text, and what is missing:
The core information requested for a detailed study report is absent. The document is an FDA clearance letter, which confirms regulatory approval based on submitted data, but does not detail that 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.