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The devices models DT-K11E, DT-11H, are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

electronic clinical thermometer

This is a 510(k) premarket notification for a digital thermometer, not an AI/ML powered device. As such, the document does not contain the information requested in the prompt regarding acceptance criteria and studies for AI/ML validation. The medical device in question is a simple electronic thermometer.

Therefore, I cannot provide the requested information from the provided text.

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The devices models DT-K11B, DT-K111B, DT-K111D, DT-111D, DT-111G, DT-11G, DT-Y111D are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

Rapid digital thermometer DT-K11B, Rapid digital flexible thermometer DT-K111B DT-K111D, Digital flexible thermometer DT-111G DT-111D, Digital Thermometer (Water-proof) DT-11G, Predictive Digital Thermometer DT-Y111D

The provided text outlines the FDA's 510(k) clearance for several digital thermometers. While it confirms the clearance and lists the indications for use, it does not include detailed information about the acceptance criteria and the study that proves the device meets those criteria.

Therefore, I cannot provide the requested information from the given text. The document is an FDA clearance letter, not a detailed technical report of the device's validation study.

To answer your request, I would need a different type of document, such as:

• A summary of safety and effectiveness data (SSE) submitted to the FDA.
• A clinical study report.
• A test report detailing performance validation.

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The devices models DT Series (barring model DT-201A and DT-211A) are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

The device model DT-201A and DT-211A are electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.

Not Found

This document is a 510(k) premarket notification from the FDA, determining substantial equivalence for a range of digital thermometers. It does not contain specific information about acceptance criteria for device performance or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance data.

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