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The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies.

The YUWELL® infrared thermometer is designed for measuring the body's frontal temperature, is a handheld non-contact infrared thermometer, battery powered, using the infrared energy emitted in the subject's forehead area within 0-5cm that converts a user's forehead temperature. The measurement reference sites is the center of the brow. The temperature measurement takes only 1 second, does not contact human skin. The infrared thermometer is intended for use on people of all ages except pre-term babies.

The YUWELL Infrared Thermometer (models YT-1, YT-1A, YT-1B, YT-1C, YT-2, YT-2A, YT-2B, YT-2C) underwent non-clinical (bench) testing to demonstrate substantial equivalence to its predicate device, the Braun No touch + Forehead NTF3000 Thermometer (K163516).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the typical format of a clinical study report with specific statistical thresholds for metrics like sensitivity, specificity, or accuracy. Instead, the performance is demonstrated by conformity to recognized consensus standards for medical thermometers. The key acceptance criteria are the accuracy specifications described by ASTM E 1965 and ISO 80601-2-56.

The following table summarizes the device's accuracy specifications, which serve as the internal acceptance criteria regarding temperature measurement performance:

Beyond accuracy, other "criteria" for acceptance are successfully meeting the requirements of various international standards as listed in Section 5.9, including:

• Software verification and validation (FDA Guidance for software in medical devices)
• Biocompatibility (ISO 10993 and FDA Bluebook memo G95-1)
• Electrical safety (IEC 60601-1)
• Electromagnetic compatibility (IEC 60601-1-2)
• Home use (IEC 60601-1-11)

The document states, "all testing results have come back as positive results or pass for the subject device," indicating that these criteria were met.

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

The document describes non-clinical (bench) testing. Therefore, there is no "test set" of patient data in the context of a clinical study, nor data provenance (country of origin, retrospective/prospective). The performance testing was conducted according to ASTM E 1965 and ISO 80601-2-56, which are standards for infrared thermometers' performance. These standards involve laboratory testing with controlled temperature sources, not human subjects in a clinical setting. The specific sample sizes (e.g., number of measurements) for these bench tests are not provided in this summary.

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

Not applicable. This was a non-clinical (bench) study involving physical and electrical performance measurements against established standards, not interpretation by medical experts.

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

Not applicable. As this was non-clinical bench testing, no adjudication of expert opinions was required.

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 is not an AI-powered device, nor does it involve human "readers" or case interpretation. It is a standalone infrared thermometer.

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

Yes, the testing described is a standalone performance assessment of the device itself (the "algorithm" in a sense, refers to the device's internal measurement and processing capabilities) without human interpretation in the loop influencing the measurement output. The device functions as a direct measurement tool. The "Performance test according to ASTM E 1965 and ISO80601-2-56" is a standalone evaluation of the device's ability to accurately measure temperature under controlled conditions.

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

The ground truth for the "performance test" was established by calibrated reference temperature sources, as is standard for testing medical thermometers according to ASTM E 1965 and ISO 80601-2-56. These standards dictate precise methods for measuring the accuracy of temperature readings against known, stable temperatures.

8. The sample size for the training set

Not applicable. This is a traditional medical device (infrared thermometer), not an AI/Machine Learning device that requires a training set.

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

Not applicable. This is a traditional medical device, not an AI/Machine Learning device.

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