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The Infrared Thermometer (Model: PC808) is intermittent measurement of ear and forehead temperature at home. It can be used for anybody, e.g. for new-born, for children and for adults. The thermometer is touch for the forehead measurement site.

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I am sorry, but the provided text does not contain detailed information about the acceptance criteria, specific test results, sample sizes, expert qualifications, or study methodologies for a device's performance. The document is an FDA 510(k) clearance letter for an Infrared Thermometer, model: PC808, stating that the device is substantially equivalent to legally marketed predicate devices.

The document discusses:

• The FDA's review of the premarket notification.
• The device name and model.
• The regulation number and name for clinical electronic thermometers.
• The regulatory class (Class II).
• Indications for Use: intermittent measurement of ear and forehead temperature at home for anybody (newborn, children, adults), with touch for forehead measurement.
• Type of Use: Over-The-Counter Use.
• General controls provisions of the Act that the manufacturer must comply with.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Information about experts used to establish ground truth.
• Adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of detailed performance data is typically found in the full 510(k) submission, not in the clearance letter itself.

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The Infrared thermometer Model PC868 can measure body temperature from the forehead of infants and adults without contact to the human body, it can be used by consumers in household environment and by doctors in the clinic.

All objects above absolute zero temperature emits certain percentage of infrared radiation energy based on its temperature. The amount of the radiation energy and the distribution of the wavelength have very closely relationship. When human forehead's temperature in 36-37°C, it emits wavelength 9-13um of infrared radiation. Based on this principle, according to the relationship between surface forehead temperature, we are able to measure the human forehead's actual temperature through measuring surface forehead temperature. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The predicate device KI-8280, use the same detection principle to measure the patient's temperature.

These thermometers are a kind of measurement device that utilize infrared radiation to measure forehead and object temperature. The Infrared Thermometers main function as following:

• Forehead and object temperature measure functions
• Have wide range of temperature readings: from 32.0°Cto 42.9°C
• The big LCD display can clear showing the measure result.
• Have memory function
• Low battery indicator
• Have backlight function
• Have ambient temperature detection function

The power supply of Infrared Thermometer is DC 3.0 V, which is offered by two AAA batteries.

This thermometer uses thermopile as the temperature sensor. The enclosure cover is made of ABS plastic material. The thermometer mainly includes the following components: MCU, PCB, LCD, Infrared Sensor, Probe, Batteries, Buzzer, Backlight and Enclosure Cover.

There are only one patient contacting materials: ABS plastic. The material also meet the test requirements of ISO10993-5 (In vitro cytotoxicity) and ISO10993-10 (Irritation and delayedtype hypersensitivity).

The subject device of PC868 also use the focusing design to collect the infrared emitted from nearby area of object surface. This mechanism make the subject device have the ability to detect the object surface temperature.

The compact, small and light-weight design, the Shenzhen Pacom Medical Instruments Co., Ltd. Infrared Thermometer, model PC868, enables to provide safe and reliable result and offers a very good clinical accuracy for human body temperature measurements.

The document describes the regulatory submission for the Infrared Thermometer, Model PC868. This device is a non-contact infrared thermometer intended to measure body temperature from the forehead of infants and adults. The acceptance criteria and the study proving the device meets these criteria are detailed, primarily through a comparison to a predicate device (K-jump Health Co., Ltd.'s Non-contact Infrared Thermometer, model KI-8280, K102947) and adherence to recognized standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criterion for the PC868 thermometer, especially for clinical performance, is compliance with ASTM E 1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature). This standard sets the requirements for accuracy.

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

The document states, "The clinical performance test protocol and data analysis is followed the requirements the ASTM E 1965-98." However, it does not explicitly state the sample size for the clinical test (test set) or the data provenance (e.g., country of origin, retrospective or prospective). ASTM E 1965-98 specifies the number of subjects and measurements required for clinical accuracy testing (typically a minimum of 20 subjects). While the submission states "conforms to applicable standards," the specific details of the test population are not provided in this excerpt.

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

This type of device (infrared thermometer) measures a physical quantity (temperature). The "ground truth" for temperature measurement in a clinical test is typically established using a calibrated reference thermometer, not human experts' subjective interpretations. Therefore, no "experts" (like radiologists) were used to establish ground truth in the way one might for an imaging AI device. The accuracy is assessed by comparing the device's readings against a highly accurate reference.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is a physical measurement against a reference standard, not a subjective interpretation requiring adjudication.

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

No MRMC comparative effectiveness study was done for this device. Infrared thermometers are not devices that require human readers to interpret outputs in the same way as medical imaging (e.g., X-rays, MRI). The device provides a direct temperature reading. The study primarily focused on the device's standalone performance and comparison to a predicate device's specifications and relevant industry standards.

6. Standalone Performance

Yes, a standalone performance study was done. The document explicitly states the device's performance metrics, such as accuracy and measurement range, and confirms its adherence to standards like ASTM E 1965-98, IEC 60601-1, and IEC 60601-1-2. The "Performance Summary" table (Section 6.0) confirms that various performance aspects were evaluated and found to conform to recognized consensus standards.

7. Type of Ground Truth Used

The ground truth used for this type of device is direct physical measurement comparison against a calibrated reference standard. For clinical accuracy, this means comparing the thermometer's readings to core body temperature (or a proxy for it, as per ASTM E 1965-98, often oral or rectal temperature measured by highly accurate reference thermometers) in a controlled clinical environment.

8. Sample Size for the Training Set

This document pertains to a medical device's conformity assessment and 510(k) submission, not an AI/ML device where a "training set" would be relevant for model development. The device is a traditional electronic thermometer, not an AI algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable to this device.

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

As stated above, this question is not applicable because the device is a traditional electronic thermometer and does not involve AI/ML with a training set.

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