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The device is intended for the intermittent measurement and monitoring of human body temperature, by consumers in the home.

Infrared Thermometer Model: FDIR-VI is a hand-held, reusable, battery operated, maximum device that can measures human body temperature by two ways.

1. on forehead, the skin temperature on one's forehead.
2. in ear, the tympanic temperature in one's ear.
   The operation principle is based on Infrared Sensor technology. IR Sensor can putout different signal when measuring different object temperature or in different ambient temperature, an ASIC can turn the signal from IR Sensor to a digital value and display it by LCD.

The provided text does not contain detailed information about a specific study with acceptance criteria and reported device performance in the format requested.

The document is a 510(k) summary for an Infrared Thermometer. It states that "The device conforms to applicable standards included ASTM E1965-98, EN 12470-5: 2003, IEC 60601-1 and IEC 60601-1-2 requirements." and that "tests in this submission provide demonstrate these small difference do not raise and new questions of safety or effectiveness." This implies that the device was tested against these standards, and its performance met the requirements within them, leading to the conclusion of substantial equivalence to a predicate device.

However, the specific "acceptance criteria" (e.g., accuracy +/- 0.X degrees C), the numerically "reported device performance," and other details like sample sizes, ground truth establishment, or expert involvement are not explicitly provided in this 510(k) summary. These details would typically be found in the full test reports referenced by the submission to FDA.

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