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The Microlife Instant Digital Thermometer, Model, QT1JA1 is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm.

The Microlife Instant Digital Thermometer, Model, QT1JA1 is a hand-held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive (Instant) mode (5- seconds orally, 7- seconds rectally and under the arm-predictive temperature), or standard mode (actual determination of temperature).

The device is for the adult and pediatric population.

This predictive (instant) digital electronic thermometer enables very fast and reliable measurements. With its predicative technology, this thermometer offers very high clinical accuracy and, has been designed to provide maximum userfriendliness.

The basic principle of this thermometer is that a change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of the oscillator.

For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.

The provided document is a 510(k) summary for the Microlife Instant Digital Electronic Thermometer, Model QT1JA1. It mentions that clinical studies were performed, but it does not include the acceptance criteria or detailed results of those studies, nor does it provide information relevant to AI/ML device studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the specific questions about sample sizes, ground truth, expert involvement, or AI-related metrics.

Here's what I can extract from the provided text:

• Device Name: Microlife Instant Digital Electronic Thermometer, Model QT1JA1
• Intended Use: Intermittent measurement and monitoring of human body temperature orally, rectally, and under the arm, for adult and pediatric populations. It can operate in predictive (Instant) mode (5-seconds orally, 7-seconds rectally and under the arm) or standard mode (actual determination of temperature).
• Study Mentioned: "Controlled human clinical studies were conducted using the Microlife Instant Digital Electronic Thermometer, Model QT1JA1. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline."

Missing Information:

The document lacks critical details required to answer most of your questions, including:

1. Acceptance Criteria and Reported Performance Table: No specific acceptance criteria (e.g., accuracy bounds, precision targets) or quantified performance results (e.g., mean bias, standard deviation of differences relative to a reference method) are provided.
2. Sample Size for Test Set: Not mentioned.
3. Data Provenance (Country, Retrospective/Prospective): Not mentioned, beyond "Controlled human clinical studies."
4. Number of Experts & Qualifications for Ground Truth: Not applicable, as this is a thermometer and the ground truth would typically be a reference thermometer or a "gold standard" physiological measurement, not expert consensus.
5. Adjudication Method: Not applicable.
6. MRMC Comparative Effectiveness Study: Not applicable, as this is not an AI-assisted diagnostic device.
7. Standalone Performance Study: The clinical studies mentioned would be standalone performance studies for the thermometer, but the results are not detailed.
8. Type of Ground Truth: Implied to be a reference temperature measurement, but not explicitly stated or detailed (e.g., what kind of reference thermometer was used).
9. Sample Size for Training Set: Not applicable for a traditional electronic thermometer.
10. How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided text confirms that clinical studies were conducted to assess the performance of the thermometer, but it does not disclose the specific acceptance criteria, results, or methodologies in enough detail to answer your specific questions, particularly those related to AI/ML device evaluation.

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