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The digital thermometer is intended for the measurement and monitoring of human body temperature through or axillary as the measurement site on people of all ages by doctor or user in the hospital or home.

Digital Thermometer, Model T28, T28L

The provided document is an FDA 510(k) clearance letter for a Digital Thermometer, Model T28, T28L. This device is a standard medical instrument for measuring body temperature and does not involve AI or complex algorithms requiring extensive studies as described in the prompt's request.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML-driven medical devices, are not applicable to this specific product.

Here's a breakdown based on the characteristics of the device and the provided document:

1. A table of acceptance criteria and the reported device performance

• Not applicable in the context of AI/ML performance. For a digital thermometer, acceptance criteria would typically involve accuracy, precision, response time, and environmental operating limits, as defined by international standards (e.g., ISO 80601-2-56 for clinical thermometers). These technical performance specifications are usually provided in the device's design and testing documentation submitted to the FDA, but they are not detailed in this clearance letter. The letter confirms substantial equivalence, implying these technical specifications meet regulatory requirements.

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

• Not applicable for AI/ML performance. For a digital thermometer, testing would involve physical measurements on a range of test subjects or using calibrated thermal sources, not a "test set" of data in the AI sense. The document does not provide details on the sample sizes for these physical performance tests or their provenance.

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 applicable. "Ground truth" in the context of expert consensus is not relevant for a digital thermometer. Accuracy is typically validated against highly calibrated reference thermometers (e.g., in a metrology lab) or in clinical trials against established methods, not by expert consensus on data interpretation.

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

• Not applicable. Adjudication methods are used to resolve disagreements among multiple experts interpreting complex data, which is not relevant for the direct measurement function of a digital thermometer.

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 not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant.

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

• Not applicable. This device does not have an "algorithm only" component that operates independently for diagnosis or prediction. It's a measurement device.

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

• Not applicable in the context of expert consensus/pathology/outcomes data. For a digital thermometer, the "ground truth" for its accuracy and performance testing would be highly accurate reference measurements from certified calibration equipment or established clinical comparison methods, not subjective expert assessment.

8. The sample size for the training set

• Not applicable. This device does not use machine learning, therefore, there is no "training set."

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

• Not applicable. As there is no training set, there is no ground truth to establish for it in this context.

In summary: The FDA 510(k) clearance letter for the Digital Thermometer, Model T28, T28L, indicates a device that does not leverage AI/ML algorithms. Therefore, the detailed questions about acceptance criteria, study design, and ground truth establishment specific to AI-driven devices are not applicable to the information provided in this document. The clearance signifies that the device has demonstrated substantial equivalence to a legally marketed predicate device based on its intended use and conventional performance standards for clinical thermometers.

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