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The digital thermometers MT series are 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.

Digital Thermometer MT series enable fast and reliable measurements. These thermometers provide very high clinical accuracy, and have been designed to provide maximum user-friendliness. Digital Thermometer MT series can be used in conjunction with or without a disposable probe cover, when preferred. The basic principle of these thermometers is that a change of thermistor resistance, caused by changes of temperature, is 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 text describes a 510(k) premarket notification for the SEJOY Digital Thermometer MT series. The document asserts the device's substantial equivalence to previously cleared predicate devices. While it mentions compliance with standards and the performance of clinical studies, it does not provide detailed acceptance criteria or the specific results of those studies in a format that allows for the extraction of the requested information.

Specifically, the document states:

• "Controlled human clinical studies were conducted using the digital thermometer MT series. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline."

However, it does not provide the acceptance criteria for these metrics (e.g., maximum allowable bias, uncertainty, or repeatability), nor does it report the observed performance of the device against any such criteria.

Therefore, I cannot populate the table of acceptance criteria and reported device performance.

Furthermore, without the detailed study report, the following information cannot be extracted:

• Sample size used for the test set and the data provenance: Not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer, not expert consensus.
• Adjudication method: Not applicable for a thermometer accuracy study.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for a thermometer.
• Standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a thermometer, and its primary performance is standalone measurement. While clinical studies were done, the details of how "standalone performance" (e.g., in a laboratory setting with a reference standard) compared to human-in-the-loop (e.g., actual clinical use) are not discussed in this summary. The summary focuses on "clinical bias, clinical uncertainty and clinical repeatability."
• The type of ground truth used: Not explicitly stated, but for thermometer accuracy, it would be a reference thermometer and/or a controlled thermal environment.
• The sample size for the training set: Not applicable; this device is a hardware product, not an AI/algorithm-based device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Summary of available information:

In conclusion, while clinical studies were performed to evaluate the SEJOY Digital Thermometer MT series, the provided 510(k) summary does not contain the detailed quantitative acceptance criteria or the specific results required to populate the requested table and answer the study-specific questions. The summary focuses on declaring substantial equivalence based on overall design, intended use, and compliance with general standards (ASTM E 1112, IEC60601-1, IEC60601-1-2 and ISO10993-1).

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The model MT series digital thermometers (MT-201, 301, 402 and 403) are 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 MT-405 is intended to measure oral temperature only. It is reusable for clinical or home use for children under the age of four.

Digital Thermometer Model MT series (MT-201, MT-301, MT-402, MT-403 and MT-405) enable fast and reliable measurements. These thermometers provide very high clinical accuracy, and have been designed to provide maximum userfriendliness.

The basic principle of these thermometers is that a change of thermistor resistance, caused by changes of temperature, is 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.

This document describes the Sejoy Electronics & Instruments Co., LTD Digital Thermometer Model MT Series. The provided text, however, is a 510(k) summary for regulatory clearance and does not contain the detailed acceptance criteria or the specific study results in the format requested. While it mentions clinical studies were conducted, it does not provide the quantitative data needed to complete the table or answer all of your specific questions.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information (Based on the provided text, much of this is not available):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document states "Controlled human clinical studies were conducted using the digital thermometer model MI series."
• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The specific method for establishing "ground truth" (e.g., how the reference temperature was obtained in the clinical studies) is not detailed.

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

• Not specified.

5. 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

• Not applicable. This device is a digital thermometer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or "AI assistance" is not relevant to its performance evaluation.

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

• Not applicable in the typical sense for an AI algorithm. The device is the "standalone" measurement tool. The "performance" being evaluated is the accuracy of the thermometer itself, not an algorithm's interpretation of data for human review.

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

• For clinical thermometers, the ground truth is typically established by extremely accurate reference thermometers or highly controlled temperature environments calibrated against international standards. The document mentions "clinical bias, clinical uncertainty and clinical repeatability," which implies comparison against a reference standard, but the specific type of ground truth (e.g., calibrated reference thermometer readings) is not explicitly detailed.

8. The sample size for the training set

• Not applicable in the context of machine learning model training. This device is a hardware-based digital thermometer, not an AI model that undergoes training.

9. How the ground truth for the training set was established

• Not applicable as there is no "training set" in the context of an AI model for this device. The device's calibration and accuracy are established through engineering design, manufacturing processes, and testing against known temperature standards.

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