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Ageless Health Medical Digital Thermometers are intended for use in measuring human body temperature (Armpit or Oral).

Ageless Health Medical Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD.

The provided text is a 510(k) summary for the Ageless Health Medical Digital Thermometer, a medical device. It outlines the device's technical specifications and demonstrates its substantial equivalence to a predicate device. However, this document does not contain the information requested regarding acceptance criteria and the study that proves an AI/ML powered device meets those criteria.

Specifically, the document discusses:

• Device identification: Ageless Health Medical Digital Thermometer.
• Regulatory information: Class II medical device, product code FLL, regulation number 21 CFR 880.2910, 510(k) number K152508.
• Intended Use: Measuring human body temperature (armpit or oral).
• Device Description: It's a digital thermometer using a thermistor, reference resistor, buzzer, ASIC, and LCD display.
• Predicate Device: SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. Electronic thermometer (K131210).
• Test Summary: Mentions lab bench testing according to various IEC, ASTM, and ISO standards (e.g., IEC 80601-2-56 for clinical thermometers, ASTM E1112 for electronic thermometers, ISO 10993 for biocompatibility), but does not provide the results of these tests in detail or the specific acceptance criteria met. It only states that "The same tests on Ageless Health Medical Digital Thermometer and the predicate device demonstrate the substantial equivalence of the two."
• Comparison to Predicate Device: A table comparing various elements, including measurement range, accuracy, ambient temperature, and response time. It notes some differences but concludes substantial equivalence because both comply with relevant performance standards.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text, as this information is not present for an AI/ML powered device. The document relates to a traditional digital thermometer and focuses on substantial equivalence based on existing standards and predicate device comparison, rather than a novel AI/ML performance evaluation.

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