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Infrared Ear/Forehead Thermometer DET-218 is intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.

The Infrared Ear/Forehead Thermometer is a hand-held, battery powered device designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead.

The Infrared Ear/Forehead Thermometer use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a thermopile collect, the infrared energy emitted from the forehead.The results can be displayed on LCD. And, the results measured by DET-218 can also be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application APP installed on a mobile device using the iOS system or the Android system. The thermometer is reusable for home use on people of all ages with adult supervision. The device can be used with as a stand-alone device or in conjunction with the App on a compatible BLE enabled smartphone.

The purpose of data transfer to a mobile device is convenient for users to view the measured data through the APP. The APP operating system is IOS 9.0+ system , Android 5.0+ system.

The name of APP is "Healthforyou",it adopts AES+RSA combination to encrypt and decrypt interface parameters and the data transmission between APP and server adopts HTTP+SSL mode to ensure the security of information.

The App only visualizes the Measurements from the device via. bluetooth to smart phone. The APP receives and records data, and displays measurement on smart phone in correspondence with DET-218 Measurement site (Ear/Forehead) set. The App has the following functions:

l. data recording;

II. curve display;

III. alarm functions.

The light bar of DET-218 turns on green light when the measurement is

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the infrared ear/forehead thermometerDET -218 are established by relevant international standards, particularly ASTM E1965-98 (2016) for clinical performance. The reported device performance is stated to comply with these requirements.

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

• Sample Size for Clinical Performance Test: 150 subjects.
• Data Provenance: The document does not explicitly state the country of origin for the clinical test data. It only mentions that "clinical tests were conducted on the DET-218." It is reasonable to assume it was a prospective study, as it was conducted to evaluate the device's performance against a standard. The study included three groups based on age:
  • Infants: newborn to one year
  • Children: greater than one to five years
  • Adults: greater than five years old

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical performance test. The ground truth method is described below.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The clinical performance test protocol and data analysis were conducted as per the requirements of ASTM E1965-98 (2016). This standard typically outlines the methods for comparison against a reference thermometer, implicitly defining the ground truth measurement process rather than an adjudication among multiple readings of the device under test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a thermometer, and its performance is evaluated against reference measurements rather than subjective human interpretation of cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The entire summary focuses on the device (Infrared Ear/Forehead Thermometer DET-218) and its conformance to standards. The "clinical tests" described are for the device itself, not for an algorithm where human input is part of the performance metric. The device also has an associated app, but the app's function is for data visualization, recording, and alarm, not for independent diagnostic or measurement capabilities requiring a human in the loop for its core function.

7. The Type of Ground Truth Used

The ground truth for the clinical performance test was established by a reference measurement method as defined by ASTM E1965-98 (2016). This typically involves comparing the device's readings against highly accurate reference thermometers or established clinical measurement techniques to determine accuracy. It is not expert consensus, pathology, or outcomes data in the usual sense for diagnostic imaging or similar devices.

8. The Sample Size for the Training Set

The document describes a clinical performance test, which is a test set evaluation. It does not mention a "training set" or any machine learning model training process for the core measurement functionality of the thermometer. The device's operation is based on physical principles (measuring thermal radiation), not a data-trained algorithm for its primary measurement.

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

As no training set is mentioned for the primary measurement function of the device, this question is not applicable based on the provided text.

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Infrared Thermometer DET series are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.

The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead. The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a thermopile collect, the infrared energy emitted from the forehead. The Infrared thermometer included DET-205,DET-305,DET-305,DET-306 and DET-215. DET-205 and DET-206 units are contact Infrared forehead thermometer,DET-305 and DET-306 units are non-contact Infrared forehead thermometer(measurement distance is 2~3cm), DET-215 unit is multifunction infrared thermometer and it can be selected Ear mode or Forehead mode. In addition,all models have voice function that used to broadcast the measurement temperature results after complete the measurement. It's working principle is that Microcontroller Unit sends voice commands to the voice integrated circuit and then broadcast the measurement temperature results that display on the LCD.The voice function is use English language and actives after each measurement completed.

The provided document is a 510(k) premarket notification for a medical device (Infrared Thermometers). It details the substantial equivalence of the subject device to legally marketed predicate devices, focusing on technical specifications and conformance to standards. However, it does not include the specific details typically found in a study proving a device meets acceptance criteria related to AI/ML performance, especially those involving human expert review, MRMC studies, or clear ground truth establishment for a test set. This document describes the validation of a traditional hardware thermometer, not an AI-powered device.

Therefore, many of the requested items (e.g., sample size for test set provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance for AI, training set details) are not applicable to this document as it concerns a non-AI/ML device.

Here's an attempt to extract the relevant information based on the document, noting where the requested information is absent or not applicable:

Device Type: Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
Models: DET-205, DET-206, DET-305, DET-306, DET-215

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for these thermometers are based on conformance to recognized standards, primarily ASTM E1965-98 for performance and ISO 80601-2-56 for general safety and essential performance of clinical thermometers. The key performance metric is accuracy of temperature measurement.

Additional Conformance Standards:

• IEC 60601-1:2012 (Safety)
• IEC 60601-1-2:2014 (EMC)
• ISO 10993-5:2009 (Biocompatibility - In Vitro cytotoxicity)
• ISO 10993-10:2010 (Biocompatibility - irritation and skin sensitization)
• IEC 60601-1-11:2015 (Home healthcare environment)

The document states that a clinical performance test protocol and data analysis were conducted as required by ASTM E1965-98 (2016), and "The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016)."

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

• Sample Size for Clinical Tests: 165 subjects.
• Data Provenance: Not explicitly stated regarding country of origin, but the submitting company is based in China. The study is described as "clinical tests were conducted," implying a prospective study for the device's performance evaluation.
• Subject Groups: Infants (newborn to one year), Children (greater than one to five years), and Adults (greater than five years old).

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

Not Applicable. For a traditional thermometer, "ground truth" for temperature measurement is typically established using highly accurate reference thermometers or through controlled calibration procedures traceable to national standards, not through human expert review or consensus as would be the case for AI image interpretation. The clinical study evaluates the device's reading against an established reference method.

4. Adjudication Method for the Test Set

Not Applicable. As "ground truth" is not established by human experts in this context, an adjudication method is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. This is a hardware thermometer, not an AI/ML device. Therefore, no MRMC comparative effectiveness study was conducted to evaluate human reader improvement with AI assistance.

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

Not Applicable. This is a hardware device; there is no AI algorithm to evaluate in a standalone manner. The device's performance is intrinsically its "standalone" performance.

7. The Type of Ground Truth Used

The ground truth for temperature measurement would typically be established by:

• Comparison with a traceable reference thermometer (e.g., in a laboratory setting for accuracy testing against a known temperature).
• In the context of the "clinical performance test," it refers to the device's ability to accurately measure human body temperature as determined by standardized clinical protocols (e.g., comparison to rectal temperature as a gold standard in some contexts, or high-accuracy reference thermometers within a controlled clinical environment). The document explicitly states the test "complied with the requirement of ASTM E1965-98 (2016)," which outlines the methodology for clinical accuracy testing of infrared thermometers against a reference thermometer.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware device, not an AI/ML model that requires a training set.

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

Not Applicable. No training set was used.

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