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The Electronic Thermometers (AET-F101, AET-F221, AET-F241) are intended to measure human body temperature orally or under the arm. The devices are reusable for clinical or home use on people of all ages.

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

I am sorry, but the provided text is an FDA 510(k) clearance letter for an Electronic Thermometer. It does not contain information about the acceptance criteria, device performance, or any studies using AI or human readers. The document is a regulatory approval and does not detail the technical performance evaluation in the way requested in your prompt.

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The Electronic Thermometers(AET-E201, AET-E21, AET-E231, AET-E241, AET-E241, AET-E251, AET-E301, AET-E311) are intended to measure the human body temperature orally, or axillary, and the devices are non-sterile, reusable for clinical or home use on people of all ages.

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This is an FDA clearance letter for a medical device (Electronic Thermometer), not a study report. Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and safety and effectiveness. The FDA clearance process for a 510(k) often involves demonstrating compliance with recognized standards or conducting comparison testing against a predicate device, but the details of such testing (like specific acceptance criteria, sample sizes, ground truth, etc.) are typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested table and information based on the provided text.

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