(156 days)
The Infrared thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.
The Infrared thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use. The Infrared thermometer has the following features
- 1 second measure the temperature.
- Sensor measurement technology.
- Automatically power-off, if left idle for 60 seconds.
- One-key measurement.
- Prompt for fever.
- Stores 12 sets recent measurement data for your data contrast.
- Safety by infrared measuring.
YK-IRT1 is divided into System initialization module, Temperature Signal sample module, AD (Analog signal/Digital signal) sample process module, Beyond the threshold process module,Key processing module, Power Manage module,User Interface module.
The provided text describes the acceptance criteria and a clinical study conducted to demonstrate the safety and effectiveness of the YK-IRT1 Infrared Thermometer.
Here's the breakdown of the requested information:
Acceptance Criteria and Reported Device Performance
The clinical study was performed according to ASTM E1965-98, Standard Specification For Infrared Thermometers For Intermittent Determination Of Patient Temperature. The acceptance criteria are implicitly defined by the values specified in this standard for clinical accuracy and repeatability. The reported device performance is presented as clinical standard deviation, mean absolute deviation, and clinical repeatability for different age groups.
| Item | Acceptance Criteria (from ASTM E1965-98) | Reported Device Performance (YK-IRT1 Infrared Thermometer) | Match |
|---|---|---|---|
| Ear Temperature (0-1 year old) | Values specified in ASTM E1965-98 | Clinical standard deviation: 0.13 | |
| Mean absolute deviation: 0.11 | |||
| Clinical repeatability: 0.06 | Yes | ||
| Ear Temperature (1-5 years old) | Values specified in ASTM E1965-98 | Clinical standard deviation: 0.16 | |
| Mean absolute deviation: 0.13 | |||
| Clinical repeatability: 0.06 | Yes | ||
| Ear Temperature (Above 5 years old) | Values specified in ASTM E1965-98 | Clinical standard deviation: 0.14 | |
| Mean absolute deviation: 0.11 | |||
| Clinical repeatability: 0.06 | Yes |
Note: The exact numerical acceptance criteria from ASTM E1965-98 are not explicitly stated in the provided text, but the conclusion states that the device "all conform to the values specified in ASTM E1965-98."
Details of the Study Proving Acceptance Criteria
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Sample size used for the test set and the data provenance:
- Sample Size: 161 subjects in total, divided into three age groups (at least 30 subjects per group), as determined by referring to Term X2.3.1 of the Appendix to ASTM E1965-98.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective, but clinical trials are generally prospective. The comparison to other thermometers (oral mercury-in-glass thermometer, Braun PRO 6000 ear thermometer, TVT-200 forehead thermometer) suggests a controlled clinical setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth was established by comparing the YK-IRT1 readings to a "calibrated oral mercury-in-glass thermometer used in the hospital." The document does not specify the number or qualifications of medical professionals involved in taking these measurements.
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Adjudication method for the test set:
- The document implies a direct comparison method where the YK-IRT1's measurements are compared against the ground truth established by the oral mercury thermometer. It also compares the ear temperature results to a Braun PRO 6000 ear thermometer and forehead temperature results to a TVT-200 forehead thermometer of the control group. There is no mention of an adjudication process involving multiple human readers for the test set results.
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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:
- No. This is a study for an infrared thermometer, not an AI-assisted diagnostic device. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The clinical trial directly assessed the device's accuracy and repeatability by comparing its readings to a reference standard (calibrated oral mercury-in-glass thermometer) on human subjects. The device, being an infrared thermometer, operates as a standalone measurement tool.
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The type of ground truth used:
- Expert Consensus/Reference Standard: Calibrated oral mercury-in-glass thermometer used in the hospital. This serves as the reference standard for body temperature measurement.
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The sample size for the training set:
- The document describes a clinical trial (test set) but does not mention a separate "training set" for the device, as it is a measuring instrument, not a learning algorithm (like AI/ML). The device's design and calibration would be based on engineering principles and potentially internal testing, not a distinct training set in the AI sense.
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How the ground truth for the training set was established:
- Not applicable, as there is no mention of a "training set" in the context of an AI/ML device. The device's inherent accuracy and performance are developed through its engineering design and manufacturing processes, with its clinical performance validated against a reference standard in the described clinical trial.
§ 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.