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The devices models DT-02 and DT-101 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 NT-01 is an 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.

Digital Flexible Thermometer Model DT-101
Basal Digital Thermometer Model DT-02
Digital Pacifier Thermometer Model NT-01

The provided text is a 510(k) premarket notification approval letter for several digital thermometers. It does not contain information regarding the acceptance criteria, performance study details (like sample size, provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, ground truth establishment, or training set specifics.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."

This means the devices were approved based on demonstrating substantial equivalence to existing predicate devices, rather than a new clinical study with specific acceptance criteria and performance metrics described in the kind of detail typically found in a clinical trial report.

Therefore, I cannot populate the requested tables and information based on the provided text. The document is an approval letter, not a study report.

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