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The Infrared thermometer is intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.

The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead for clinical or home use. The thermometers are powered by AAA 1.5 V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF. The Infrared thermometer included DT-8806S, DT-8807S. These two models are identical on hardware and software except the physical dimensions and appearance.

The provided text describes the acceptance criteria and a clinical study for the Infrared Thermometer (Models: DT-8806S, DT-8807S). However, it lacks specific numerical data for the acceptance criteria and detailed device performance metrics from the study.

Here's an attempt to extract and organize the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the device "meets the requirements," but does not provide the specific numerical acceptance criteria or the exact measured performance values from the clinical study. It only refers to compliance with standards.

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

• Sample Size: A minimum of 150 subjects.
  • 1/3 children (greater than one to five years).
  • The rest (approximately 2/3) are adults (greater than five years old).
  • (NOTE: Infants—newborn to one year) - The study appears to categorize infants separately from children and adults, but then specifies children as "greater than one to five years" and adults as "greater than five years old," implying that infants might not have been included in the 1/3 children or 2/3 adults categories, or that the term "people of all ages" in the intended use is somewhat broader than the specific age groups mentioned for the 150-subject split. However, the exact breakdown of the 150 subjects for these age groups is not explicitly given, only the minimum of 150 and the proportion for children and adults.
• Data Provenance: Not explicitly stated (e.g., country of origin). Since the submission sponsor and correspondent are based in Shenzhen, China, it is highly probable the data originated from China, but this is an inference. The study is described as a "clinical study," implying prospective data collection for the purpose of the device's clearance.

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

The document does not mention the use of experts to establish ground truth for temperature measurements. Clinical accuracy studies for thermometers typically compare the device's reading against a "gold standard" reference thermometer (e.g., a rectal or oral thermometer), rather than expert consensus on temperature. It's implied that a reference thermometer provided the ground truth for body temperature.

4. Adjudication Method for the Test Set

Not applicable. Temperature measurement accuracy is typically determined by comparing the device reading to a reference thermometer, not by expert adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study (MRMC) is generally relevant for imaging diagnostics where human readers interpret medical images. This device is an infrared thermometer for direct measurement.

6. Standalone Performance Study

Yes, a standalone clinical performance study was conducted. The document states: "Clinical testing is conducted per ASTM E 1965-98 (Reapproved 2016)... The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ASTM E 1965-98 (Reapproved 2016)." This indicates the algorithm's (or device's) direct performance was evaluated against a standard.

7. Type of Ground Truth Used

The ground truth for the clinical accuracy study would have been established using a reference thermometer (e.g., mercury-in-glass thermometer, electronic probe thermometer) as per ASTM E1965-98, which sets standards for clinical investigations of infrared thermometers. The document does not specify the exact type of reference thermometer used.

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data." This device is a hardware product with embedded software; therefore, the concept of a "training set" as understood in machine learning (where algorithms are trained on large datasets) typically doesn't apply in the same way. The device's calibration and internal algorithms would be developed and validated internally during manufacturing and engineering processes, rather than through a distinct "training set" in the context of regulatory submission for clinical accuracy.

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

As noted above, the concept of a training set as typically described for AI/ML validation is not discussed for this device. The device's internal calibration and algorithmic accuracy would be established through engineering and manufacturing processes, likely against highly accurate temperature references in a controlled environment.

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