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The AOJ-25 series Digital Thermometer (except AOJ-25B) are designed as reusable battery-operated electronic device, and intended for the measurement of oral, armpit and rectal temperature for people of all ages at home.
The AOJ-25B is intended to measure temperature rectally only for people of all ages at home as well. The device is reusable.

The digital thermometer is designed as hand-held device which can measure human body's temperature orally, axillary (under the arm), or rectally. The results can be displayed on LCD.
The digital thermometers have several functions, such as beep indication, °C and °F unit switchable, low battery detection, memories, three-color backlight, auto automatic power off functions.
The device is a predictive digital thermometer. Users only need 10 seconds for quick reading, and will display the temperature value on the screen.

The provided FDA 510(k) K213485 submission describes the acceptance criteria and the study that proves the Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E meets these criteria.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The submission primarily focuses on the clinical accuracy of the thermometer as a key performance criterion, referencing the ISO 80601-2-56 standard.

Note: The document also mentions other performance aspects like electrical safety, EMC, and biocompatibility, which are met through compliance with relevant IEC and ISO standards. However, specific "acceptance criteria" and "reported performance" are not detailed in a table format for these aspects within the provided text, beyond stating compliance.

2. Sample size used for the test set and the data provenance

• Sample Size: A minimum of 90 subjects were used for the clinical accuracy study.
• Data Provenance: The document does not explicitly state the country of origin. It indicates a "clinical study" was conducted, referring to it as a "randomization, simple blind homologous control, pairing design of clinical investigation." It is implied to be a prospective study due to the nature of a clinical investigation outlined by the standard.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that a "reference device is introduced as required by the standard," implying that the ground truth for temperature measurements during the clinical study was established by this validated reference device, not by human expert interpretation.

4. Adjudication method for the test set

The document mentions a "simple blind homologous control, pairing design of clinical investigation." This suggests a comparative design with a reference device. It does not describe an explicit adjudication method involving multiple human readers for differing interpretations, as the ground truth is based on the objective measurement of temperature by a reference device according to the standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This device is a digital thermometer, not an imaging device requiring human interpretation of clinical images. The study focuses on the accuracy of the temperature measurement itself, not on human readers' interpretation of output.

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

Yes, the clinical accuracy study for the digital thermometer is essentially a standalone performance evaluation of the device in measuring temperature. While the device is used by a human, the performance measured is the accuracy of the device's output against a reference, not its performance in assisting human decision-making or interpretation.

7. The type of ground truth used

The ground truth for the clinical accuracy study was established by a reference device as required by the ISO 80601-2-56 standard. This reference device is used to measure the body temperature against which the subject device's measurements are compared.

8. The sample size for the training set

The document does not provide information about a separate "training set" or its sample size. For medical devices like digital thermometers, the development process typically involves calibration and validation against known standards, which is distinct from the machine learning "training set" concept often associated with AI/ML devices. The "clinical study" described serves as the validation of the final algorithm's accuracy.

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

As there is no mention of a traditional machine learning training set, the concept of establishing ground truth for it is not applicable here. The device's underlying "algorithm" (firmware) related to temperature measurement would be calibrated and developed based on the physical principles of thermistor resistance and validated through bench testing and the described clinical study against a precise reference thermometer.

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