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The Ear Thermometer, models WL-320X are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.

battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.

The provided document is a 510(k) premarket notification letter from the FDA for an ear thermometer. It acknowledges substantial equivalence to a predicate device but does not contain any information regarding specific acceptance criteria, performance metrics, or study details such as sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document confirms that the device "is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices". This implies that the device's performance is deemed comparable to existing, legally marketed devices, but the technical details of how that equivalence was demonstrated (i.e., specific studies, metrics, and thresholds) are not present in this letter.

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