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The Kendall Genius 2 Infrared Tympanic Electronic Thermometer is intended for use in patients in Acute and Alternate care settings to provide temperature measurements from the tympanic membrane and equivalent measurements of core, oral, rectal, and axillary temperature based on the tympanic reading.

The Genius 2 is a new infrared tympanic electronic thermometer comprised of a battery operated handheld thermometer unit tethered to a base station. This Class II device is an electronic clinical thermometer that measures temperature by sensing infrared emmisions from the tympanic membrane in the ear canal. Through offest adjustments, equivalent site temperatures can be displayed for oral, rectal, core, and axillary temperatures based on the tympanic reading. This clinical electronic thermometer offers a streamlined graphical user interface that walks the user through temperature measurement.

The provided text is a 510(k) summary for the Kendall Genius 2 Infrared Tympanic Electronic Thermometer. While it states that "Performance data for the Kendall Genius 2 Infrared Tympanic Electronic Thermometer is compared to that of the predicate device... Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed device," it does not actually include the detailed performance data or a specific study proving the device meets acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 based on the provided text. The document focuses on establishing substantial equivalence to a predicate device (Kendall FirstTemp Genius Tympanic Thermometer, K920713) based on intended use, materials, physical characteristics, and performance characteristics, but it does not present the specific data from such performance comparisons.

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