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Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.

Infrared Thermometer is mainly composed of infrared probe components, main circuit board components, LCD display components and housing components. The Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement. The Infrared Thermometer can be used by consumers in the household environment and by healthcare providers. The operator should be an adult with relevant experience. The operator can replace the battery, transmit data, and measure temperature.

Here's an analysis of the acceptance criteria and study details for the Infrared Thermometer Model YJ600, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Infrared Thermometer Model YJ600 are primarily defined by the standards ISO 80601-2-56 and ASTM E1965-98. The 510(k) summary directly states that the device "meets the requirement of the standard" for these and other tests. The most critical performance criterion for a thermometer is its accuracy.

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

• Sample Size (Clinical Test): 200 subjects.
  • Age Group A (0 up to 3 months): 50 subjects
  • Age Group B (3 months to one year): 50 subjects
  • Age Group C (older than one year to five years): 50 subjects
  • Age Group D (older than five years): 50 subjects
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, clinical accuracy testing is typically prospective, as it involves taking real-time measurements in a controlled study. Given the manufacturer's location (China), the study likely took place in China.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for temperature measurements in the clinical study. For infrared thermometers, the "ground truth" (reference temperature) is typically established using a highly accurate, calibrated clinical thermometer (e.g., a rectal thermometer for core body temperature) as per standards like ISO 80601-2-56 and ASTM E1965-98. The experts involved would typically be clinical staff (nurses, physicians) following a strict protocol for reference temperature measurement.

4. Adjudication Method (for the test set)

The document does not detail an adjudication method. For clinical thermometer accuracy studies, adjudication is generally not a separate process as the reference standard measurement (ground truth) is considered definitive. The "test" is how closely the device's reading matches this established reference, not a subjective interpretation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an infrared thermometer, not an AI-powered diagnostic imaging tool. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

Yes, the primary clinical accuracy and performance testing of the Infrared Thermometer Model YJ600, as described, is a standalone (algorithm only) performance assessment. The device measures and displays temperature without human interpretation of the measurement itself. While a human operates the device, the core performance being evaluated is the device's ability to accurately measure temperature independently of human judgment.

7. The Type of Ground Truth Used

The ground truth used for the clinical accuracy test is the reference body temperature measurement obtained through methods specified in ISO 80601-2-56 and ASTM E1965-98. These standards typically require comparative measurements against a highly accurate reference thermometer (e.g., an electronic thermometer measuring core body temperature, often rectal, or a precise oral measurement) to assess the deviation and repeatability of the infrared thermometer. The document specifically states "clinical repeatability" and that it "meets the clinical repeatability requirement," implying comparison against a gold standard in a clinical setting.

8. The Sample Size for the Training Set

The document does not mention or specify a "training set" because this device is a physical medical device (thermometer) and not an AI/Machine Learning algorithm that requires a separate training dataset. Its performance is based on its hardware and firmware, which are designed and then validated through testing.

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

As there is no "training set" in the context of an AI/ML algorithm for this device, the question of how its ground truth was established is not applicable. The device's design implicitly relies on established physics principles of infrared radiation and measurement, and its accuracy is validated against clinical ground truth during performance testing.

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