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The Infrared Ear Thermometer is indicated for intermittent measurement of human body temperature from the ear canal. The device can be used by people of all ages except preterm babies or babies who are small for gestational age. The thermometer is intended for use in professional settings and the home environment. It is not for emergency clinical conditions.

YUWELL® Infrared Ear Thermometer is designed to measure human body temperature. This hand-held, no-contact device is battery-powered and utilizes infrared energy emitted in the subject's tympanic membrane to determine human body temperature. The thermometer provides temperature readings in just 2 seconds. It is suitable for individuals of all ages except preterm babies or babies who are small for gestational age. The Infrared Ear Thermometer YHT107 can transmit the temperature readings via Bluetooth, whereas the YHT100 does not have data transmission capability.

Here's a detailed breakdown of the acceptance criteria and study information for the YUWELL® Infrared Ear Thermometer, extracted from the provided FDA 510(k) clearance letter:

YUWELL® Infrared Ear Thermometer (YHT100; YHT107) Acceptance Criteria and Study Details

The YUWELL® Infrared Ear Thermometer (YHT100; YHT107) is indicated for intermittent measurement of human body temperature from the ear canal in professional and home environments, for people of all ages except preterm babies or babies who are small for gestational age.

1. Table of Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria are related to temperature accuracy, as specified by the standards ISO 80601-2-56 and ASTM E1965.

Note on Differences: The document explicitly states that the clinical validation results demonstrated that the clinical data, represented by clinical bias, limits of agreement, and clinical repeatability, met the acceptance criteria of the clinical validation protocol. This general statement confirms that the device's performance aligned with the specified requirements derived from the standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 154 subjects.
  • Infants: 50 subjects (newborn to one year)
  • Children: 50 subjects (greater than one to five years old)
  • Adults: 54 subjects (greater than five years old)
• Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "clinical study" which implies a prospective collection of data for the purpose of device validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The provided document does not specify the number of experts or their qualifications used to establish the ground truth for the clinical study. For a thermometer, the "ground truth" would typically be established by a reference temperature measurement device, but the specifics are not detailed.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). This type of method is more common for subjective assessments (like image interpretation) rather than quantitative measurements from a thermometer.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done.
  • MRMC studies are typically for evaluating the impact of AI assistance on human readers, often in image-based diagnostics. This device is a direct measurement tool (thermometer) and does not involve human interpretation of complex data that would be enhanced by AI assistance in that manner. The comparison is between the device's reading and a gold standard reference.

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

• Yes, a standalone performance evaluation was done. The clinical study directly assesses the YUWELL® Infrared Ear Thermometer's accuracy against a recognized standard (implied by "clinical bias, limits of agreement and clinical repeatability met the acceptance criteria"). The thermometer itself is the "algorithm" and it directly produces the temperature reading without requiring human interpretation for its output.

7. The Type of Ground Truth Used

• Reference Measurement (Implied): For temperature measurement devices, the "ground truth" is established by a highly accurate and calibrated reference thermometer or methodology that itself adheres to metrological standards. The document mentions "clinical bias, limits of agreement and clinical repeatability met the acceptance criteria of the clinical validation protocol," which strongly implies that the device's readings were compared against a gold standard reference temperature measurement during the clinical study.

8. The Sample Size for the Training Set

• The document does not provide information regarding a separate training set or its sample size. Infrared ear thermometers typically use fixed algorithms/calibration curves based on physical principles (e.g., Planck's Law) and extensive bench testing, rather than being "trained" on a clinical dataset in the machine learning sense. The clinical validation acts as a test of the final, calibrated device.

9. How the Ground Truth for the Training Set was Established

• As a training set is not explicitly mentioned or implied in the context of machine learning, the question of how its ground truth was established is not applicable here. The device's calibration during manufacturing and design likely relies on highly controlled temperature reference points and blackbody radiation sources, rather than a clinical "training set" with ground truth established through expert consensus or pathology.

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