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The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH1 series are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.

To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.

The provided document is a Special 510(k) summary for a medical device (Infrared Ear Thermometer, Models TH1 series). However, it does not contain the specific details about the acceptance criteria and the study that proves the device meets those criteria.

This document primarily focuses on establishing "substantial equivalence" to a predicate device (Radiant Innovation Infrared Ear Thermometer, Models TH8 series, FDA# K011059) by highlighting that the only differences are outer appearance and user manual, which do not significantly change safety or effectiveness.

While it mentions compliance with ASTM E1965 as an applicable voluntary standard, it does not provide the specific performance criteria from that standard, nor does it detail the results of the tests conducted to demonstrate compliance.

Therefore, I cannot fulfill your request for the tables and detailed information about acceptance criteria and study results based solely on the provided text.

To answer your request, I would need a document that includes:

• Specific performance specifications (e.g., accuracy, precision, response time) for the device.
• Data from a clinical or bench study demonstrating that the device meets these specifications.
• Details about the study design, sample sizes, ground truth establishment, and expert involvement.

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