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The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

The digital clinical thermometer, models ST-8A3C, and ST-8A3F, are the electronic thermometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) – controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display.

The Mesure Technology Co., Ltd. Digital Clinical Thermometer, models ST-8A3C and ST-8A3F, demonstrated compliance with ASTM E 1112-98 and other international standards to meet its acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion (Standard)	Reported Device Performance
   ASTM E 1112-98 Compliance	Compliant
   EN 60601-1 Compliance	Compliant
   EN 60601-1-1 Compliance	Compliant
   EN 60601-1-2 Compliance	Compliant
   Low Battery Detection	Displays 'Low battery'

2. Sample Size Used for the Test Set and Data Provenance:
   The provided summary does not explicitly state the sample size used for the test set or the data provenance. It indicates that the device was "designed and verified according to the US standard ASTM E 1112-98," which implies testing was conducted. However, specific details about the number of measurements, patients, or the origin of the test data (e.g., country of origin, retrospective or prospective) are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
   This information is not applicable and is not provided in the 510(k) summary. The device's performance is assessed against recognized standard specifications (e.g., ASTM E 1112-98), rather than requiring expert adjudication of results.

4. Adjudication Method for the Test Set:
   This information is not applicable and is not provided in the 510(k) summary. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessment, which is not the case for a digital clinical thermometer.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
   This is not applicable as the device is a standalone clinical thermometer measuring body temperature, not an AI-assisted diagnostic tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
   Yes, the performance evaluation described would be considered standalone. The "device performance" refers to the thermometer's ability to accurately measure and display temperature according to the specified standards without human interaction influencing the measurement itself. The device uses an ASIC for calculation, which functions as an algorithm.

7. The Type of Ground Truth Used:
   The ground truth for the performance evaluation of the thermometer would be established by the reference standards and methodologies outlined in ASTM E 1112-98 and other applicable standards. This typically involves comparison against known, precisely controlled temperatures (e.g., from a calibrated temperature bath) or highly accurate reference thermometers, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:
   The provided 510(k) summary does not mention a "training set" in the context of machine learning or AI. As a medical device that measures temperature using a thermistor and ASIC, its development and verification rely on engineering principles and adherence to standards rather than a machine learning training paradigm.

9. How the Ground Truth for the Training Set Was Established:
   Not applicable, as a "training set" in the machine learning sense is not mentioned or relevant to the development and testing of this type of digital clinical thermometer. The "ground truth" for its accuracy and performance is established through calibration against physical standards as defined by test methodologies in ASTM E 1112-98.

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