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Microlife QT1JC1 Instant Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm.

The Microlife QT1JC1 Instant Thermometer is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 5-seconds in oral and rectal mode, 8-seconds in under the arm mode-predicative temperature ) , or standard mode ( actual determination of temperature).

The device is for the adult and pediatric population.

This Instant thermometer enables very fast and reliable measurements and with its predicative technology the thermometer offers a very high clinical accuracy and has been designed to provide a maximum of user- friendliness

The basic principle of this thermometer is that 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 oscillator.

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

The provided text describes a 510(k) summary for the Microlife Instant Digital Electronic Thermometer, Model QT1JC1. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study results, sample sizes, expert qualifications, and ground truth methodologies is not explicitly available in the provided document.

However, I can extract the information that is present and highlight what is missing.

Acceptance Criteria and Device Performance (Based on available information)

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. The document states "Controlled human clinical studies were conducted," but does not provide the number of subjects or measurements.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The document mentions "clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline," but does not detail how ground truth references were established or who established them. For thermometers, ground truth is typically a high-precision reference thermometer, not expert consensus.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for qualitative or subjective assessments where human interpretation is involved. For thermometer measurements, the ground truth is usually an objective measurement from a reference device, not subject to expert adjudication in this manner.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a digital electronic thermometer, not an AI-assisted diagnostic imaging device or a system involving human readers interpreting data.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Thermometers are inherently standalone devices in their measurement function. The "algorithm" here refers to the internal processing of the thermistor resistance changes. The clinical studies would have evaluated the performance of this device in a standalone manner. The document states "Controlled human clinical studies were conducted using the Microlife Instant Digital Electronic Thermometer, Model QT1JC1." This implies evaluating the device's output directly.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Implied objective measurement/reference standard. For clinical thermometers, the ground truth for temperature measurements is typically established using a highly accurate reference thermometer (e.g., a mercury-in-glass thermometer or a precision electronic thermometer) in a controlled environment, often in comparison to core body temperature. The document refers to "clinical bias, clinical uncertainty and clinical repeatability," which are metrics assessed against a known reference.

7. The sample size for the training set:

   • Not applicable/Not specified. This device uses a "predictive technology" based on an R-C oscillator circuit and thermistor resistance changes. The "temperature measurements algorithm" mentioned is likely a deterministic algorithm or a calibration curve, not a machine learning model that requires a distinct "training set" in the modern sense. The document states the algorithm and fundamental scientific technology are identical to the predicate device, suggesting a proven, established method.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. As there's no mention of a traditional "training set" for a machine learning model, the establishment of ground truth for such a set is not discussed. The device's underlying principle is described as converting thermistor resistance changes to frequency changes to determine temperature, which is a physics-based, calibrated approach.

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