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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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Infrared Thermometer Model: DT-8806H/DT-8806 Non-contact body infrared thermometer is designed for body surface and forehead temperature measurement for infants and adults without contact to human body. The Digital Infrared Ear Thermometer Model: DT-886 can provide a stable, hear –interference ~free reading with each measurement, The digital Infrared Thermometer is intended for the periodic measurement and monitoring of human body temperature, It is intended for use on people of all ages. The Infrared Thermometer can be used by consumers in household environment. It is manufactured in accordance with the ASTM E1965-1998 Standard specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.

Infrared Thermometer Model: DT-8806H/DT-8806/DT-886 is medical instruments, used as an assistant device by normal people to evaluate, by the result of measurement, their decision for the next clinical step in order to protect human's health. The function for measuring human body's temperature with precision helps detect and observe human states of health, in case of any possible illness.

Infrared Thermometer Model: DT-8806H/DT-8806 is a hand-held, non-sterile, reusable medical device, Use and alcohol swab or cotton tissue moistened with alcohol(70% Isopropyl) to clean, the Digital Infrared Ear thermometer(DT-886) casing and the measuring probe contact body. supplied by internal power. It is used for human beings, and it belongs personal use monitoring device.

Infrared Thermometer Model:DT-8806/DT-8806H/DT-886 is hand-held, reusable, battery operated.The device that can measures human body temperature by ways:

1. on forehead,the skin temperature on one's forehead(DT-8806H/DT-8806); 2.In ear.The tympanic temperature in one's ear(DT-886).

The operation principle is based on Infrared Sensor technology.IR Sensor can putout different signal when measuring different object temperature or in different ambient temperature. An ASIC can turn the signal from IR Sensor to a digital Value and display it by LCD.

The provided text describes an Infrared Thermometer (Models: DT-8806H/DT-8806/DT-886) and its 510(k) submission. However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the format typically seen for advanced AI/ML medical devices. The information available focuses on compliance with existing standards and comparison to a predicate device.

Based on the provided text, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a structured table or provide specific performance metrics beyond compliance with standards. It states that the device conforms to "applicable standards" and that "tests in this submission provide demonstration these small differences [from the predicate device] do not raise any new question of safety or effectiveness."

Common performance metrics for thermometers include accuracy (e.g., within ±0.2°C or ±0.4°F) and repeatability. While these are implied by compliance with ASTM E1965-98, the specific numerical acceptance criteria and the device's reported performance against them are not detailed in this summary.

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

The document does not provide details on the sample size used for any specific test set, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective nature of data collection). It broadly states "Valid scientific evidence of product testing reports, software verification, and substantial equivalence are provided," but does not give specifics.

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

This information is not available in the provided text. The submission focuses on device compliance with standards and comparison to a predicate, not on a study involving human expert judgment for ground truth establishment.

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

This information is not available. Adjudication methods are typically relevant for studies where multiple human readers interpret data, which is not described here.

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

An MRMC comparative effectiveness study was not conducted. This device is a standalone infrared thermometer and does not involve AI assistance for human readers.

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

Yes, a standalone performance assessment was effectively done, as the device itself is a measurement tool. The "Performance Summary" lists the standards to which the device conforms, which inherently involves testing the device's performance directly against those standards without human intervention in the temperature measurement process itself. The "tests in this submission" would be demonstrating the device's accuracy and other specifications.

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

For a thermometer, the "ground truth" would typically be established using a calibrated reference thermometer or a precisely controlled temperature bath. The device's measurements are compared against these known, highly accurate temperature sources to determine its accuracy and precision. The document doesn't explicitly state "calibrated reference thermometer," but compliance with standards like ASTM E1965-98 would necessitate such a method.

8. The sample size for the training set

This device does not appear to involve machine learning or AI models that would require a "training set" in the conventional sense. Therefore, this information is not applicable/not provided.

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

As there is no indication of a training set for an AI/ML model, this information is not applicable/not provided.

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