(144 days)
Non-Contact Infrared Thermometer, Model KI-8280, can measure body temperature for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
The Non-Contact Infrared Thermometer, Model KI-8280, uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the objects, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The predicate device, JXB Thermoflash, use the same detection principle to measure the patient's temperature. The subject device 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 in the distance of 3-8cm. The subject device intended to detect the temperature of patients. The temperature is converted to the oral temperature. The temperature reading shown in the device display after measuring is the patient's oral temperature. The compact, small and light-weight design, the K-jump Health Co, Ltd. Non-Contact Infrared Thermometer, Model KI-8280, enables to provide safe and reliable results and offers a very good clinical accuracy for human body temperature measurement.
Here's a breakdown of the acceptance criteria and the study details for the Non-Contact Infrared Thermometer, Model KI-8280, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (KI-8280) |
|---|---|
| ASTM E1965 (Clinical Accuracy) | Met the requirements; patient's temperature readings difference with digital thermometer within acceptable range. |
| EN 12470-5 | Complied |
| IEC 60601-1 (Safety) | Complied |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Complied |
| Measuring Accuracy (Forehead Mode) | ±0.2℃ (0.4°F) |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- The document states that the clinical performance test protocol and data analysis followed the requirements of ASTM E 1965. However, it does not explicitly state the specific sample size used for the test set of patients.
- Data Provenance: Not explicitly stated, but clinical testing was conducted. It's common for such tests to be prospective, but this is not explicitly confirmed. The company is based in Taiwan, so it's possible testing occurred there or in another location appropriate for clinical studies.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the summary. The study refers to comparing the device's readings with a "digital thermometer," implying this was the reference standard, but details on how the ground truth was established for the digital thermometer readings (e.g., expert interpretation) are absent.
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Adjudication Method for the Test Set:
- This information is not provided. The study focused on the difference between the device's readings and a digital thermometer, rather than using an adjudication process for subjective assessments.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. This device is a direct measurement tool.
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Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Yes, the performance reported is for the standalone device. The device measures and displays temperature directly without requiring human interpretation of an output, making its performance inherently standalone. The clinical test evaluated the accuracy of the device's temperature readings.
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Type of Ground Truth Used:
- The ground truth was established by readings from a digital thermometer, which is considered a standard clinical reference for temperature measurement.
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Sample Size for the Training Set:
- This information is not provided. The summary does not discuss a "training set" in the context of machine learning (which this device pre-dates and doesn't rely on in the typical sense). The performance testing described relates to the final device against a known standard.
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How the Ground Truth for the Training Set Was Established:
- As no training set is discussed in the context of machine learning, this information is not applicable. For the clinical validation, the ground truth was established by comparing the device's readings to those of a digital thermometer.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.