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The No Touch + Forehead Thermometer (Model NTF3000US) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch on the centre of the forehead as the measurement site on people of all ages.

The No Touch+Forehead Thermometer ( Model NTF3000US) is a hand-held, battery powered device designed to measure human body temperature. The NTF3000 is an Infrared thermometer that converts a user's forehead temperature using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when placed in contact with the subject's forehead or up to two (2) inches away. The NTF 3000 thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection of contact or non-contact use and compensation of the temperature reading.

Here's a breakdown of the acceptance criteria and study information for the KAZ USA, Inc. No Touch+ Forehead Thermometer (Model NTF3000US), based on the provided text:

Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the No Touch+ Forehead Thermometer are established by its conformance to the ASTM E1965-03 standard for clinical accuracy and repeatability. The device needed to demonstrate non-inferiority or substantial equivalence to the predicate device against a gold standard.

Study Details

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document states that a comparison study was performed across four age groups: 0-12 months, 12 months-

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The Behind Ear Gentle Touch Thermometer (Models V980/BET 1000) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature using behind the earlobe as the measurement site on people of all ages.

The over-the-counter Behind Ear Gentle Touch Thermometer - Models V980/ BET 1000 is a hand-held, battery powered device designed to measure human body temperature by detecting heat flow on the skin directly behind the ear lobe as a measurement site, by using the heat conduction principal and prediction. The skin area over the posterior auricular artery passing behind the earlobe is the measurement site, which is very close to the cantharid artery. These arteries carry blood to the brain and therefore the site is the best external place to measure temperature. The Behind Ear Gentle Touch Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site by heat transfer data and mathematical algorithm. The temperature reading range is from 95.0° F to 107.6° F (35°C to 42 °C) and the time of measurement is about 1 second.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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