(121 days)
THE DEVICE IS INTENDED TO READ THE TEMPERATURE OF ANY PEOPLE , WHEN NEEDED.
- IT ADOPTS EITHER FAHRENHEIT OR CENTIGRADE DEPENDS ON NEED.
- IT CAN BE ORAL, RECTAL OR AXILLLARY USE.
SUPER SOOTHER CLINICAL ELECTRONIC THERMOMETER
The provided document is a 510(k) premarket notification letter from the FDA regarding the "SUPER SOOTHER CLINICAL ELECTRONIC THERMOMETER." This is a regulatory clearance letter, not a study report or a detailed performance evaluation. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methodologies.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the device's clearance is based on its substantial equivalence to a pre-existing device, not on a new, comprehensive clinical study validating specific performance metrics against pre-defined acceptance criteria as would be found in a performance study report.
Therefore, I cannot provide the requested information from the given document.
If you have a different document (e.g., a clinical study report or a detailed device specification document), I would be happy to analyze it for the criteria you've outlined.
§ 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.