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The Infrared Thermometer, Model K9 is a non-contact intended for the intermittent measurement and monitoring of human body temperature from forehead for clinical and home use environments. It can be used for anybody, e.g. for infant, children and adults (Excluding neonates). The device does not require sterilization and can be reused.

The Infrared Thermometer. Model K9 is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The device uses CapSense Technology to detect distance this technology is used to assist measurement. The concept of proximity sensor detects human electrical proximity level to transform to distance. The distance control feature is added to the user interface to identify the measurement distances are in the correct parameter. In other words, the device will enter into measurement mode after the correct measurement distance is detected. This device can take a measurement automatically when the device detects the distance is appropriate within 5 cm. The Infrared Thermometer, Model K9, consists of the following parts: a) Thermopile Sensor b) Application-Specific Integrated Circuitry c) Erasable Programmable Read-Only Memory Integrated Circuit d) Capacitance-touch Integrated Circuit e) LED and Backlight f) Alkaline batteries; size AAA, 2 x 1.5 V g) Lens

The provided document is a 510(k) summary for the Kangzhan Infrared Thermometer (Model K9), seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed product, rather than providing a standalone clinical study to establish novel performance criteria. Therefore, much of the requested information regarding detailed acceptance criteria and specific study designs to prove novel performance is not fully present or applicable in the context of a 510(k) submission. However, I can extract the information provided regarding the device's accuracy and the tests performed to establish substantial equivalence.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations of a 510(k) summary:

1. A table of acceptance criteria and the reported device performance

The document references ISO 80601-2-56 and ASTM E1965 for accuracy standards. These standards typically define the acceptance criteria for the accuracy of clinical thermometers. The performance reported directly compares to these standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Clinical testing is conducted per ISO 80601-2-56 Second edition 2017-03... Sections 201.102 Clinical Accuracy Validation." However, it does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. For clinical thermometer accuracy, "ground truth" typically involves core body temperature measurements using highly accurate reference methods, often requiring clinical expertise in the measurement procedure rather than interpretive expertise.

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

The document does not specify any adjudication method for the test set.

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

This is not applicable as the device is an Infrared Thermometer, not an AI-assisted diagnostic tool that involves "human readers." No MRMC study was conducted or reported.

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

Yes, a standalone performance evaluation was conducted for the device's accuracy against recognized standards (ISO 80601-2-56 and ASTM E1965). The reported "Reported Device Performance" in question 1 reflects this standalone performance. The device itself is an algorithm-driven electronic thermometer.

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

For clinical thermometers, the "ground truth" for accuracy validation typically involves
measurements obtained from a highly accurate reference thermometer placed at a core body temperature site (e.g., rectal, oral, or arterial catheter measurements in a clinical setting). The document does not explicitly state the specific ground truth method used, but it implicitly refers to the standards (ISO 80601-2-56) that dictate these methods for "Clinical Accuracy Validation."

8. The sample size for the training set

This is not applicable. The device is a traditional electronic thermometer, not an AI/machine learning device that typically requires a "training set."

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

This is not applicable, as there is no "training set" for this type of device.

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