(268 days)
The AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is intended for body temperature measurement from the auditory canal 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 AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. It uses infrared probe to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object. The infrared probe (Thermopile) can recognize it and transfer to the proper electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to the temperature reading, which is displayed on the LCD. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and the associated circuit. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal. Pressing the activation button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.
The provided 510(k) summary describes the acceptance criteria for the AT-6XX Series Infrared Thermometer (models AT-601 and AT-606) in terms of its accuracy and the study conducted to prove it meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device's accuracy are directly inherited from the international standard ISO 80601-2-56:2009 for clinical electronic thermometers.
| Acceptance Criteria (Accuracy) | Reported Device Performance (Accuracy) * |
|---|---|
| ± 0.2°C (35°C~42°C) | ± 0.2°C (35°C~42°C) |
| ± 0.3°C (outside of 35°C~42°C) | ± 0.3°C (outside of 35°C~42°C) |
Note: The document states "Clinical test results demonstrated that the subject device performs substantially equivalent to the predicate device." and lists the same accuracy specifications for the subject device as the predicate device. Therefore, the reported device performance is inferred to meet or exceed these specifications.
2. Sample Size and Data Provenance
The document states that a "clinical accuracy evaluation has been conducted according to clause 201.102 of ISO 80601-2-56:2009." However, the specific sample size used for the test set and the data provenance (e.g., country of origin, retrospective or prospective) are not detailed in this 510(k) summary.
3. Number and Qualifications of Experts for Ground Truth
This information is not provided in the 510(k) summary. For a clinical accuracy evaluation of a thermometer, "ground truth" typically refers to core body temperature measured by a highly accurate reference method (e.g., rectal or arterial catheter temperature). The involvement and qualifications of experts to establish this ground truth are not mentioned.
4. Adjudication Method
The 510(k) summary does not mention an adjudication method. This is usually not applicable for basic device performance studies like thermometer accuracy, where the ground truth is established by a direct measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. This type of study is more relevant for diagnostic imaging AI algorithms where human interpretation is involved. The AT-6XX Series Infrared Thermometer is a direct measurement device without human interpretation of complex data.
6. Standalone Performance (Algorithm Only)
The performance described for the device is its standalone performance. The device is an infrared thermometer, and its accuracy (± 0.2°C / ± 0.3°C) refers to the algorithm's ability to convert infrared radiation into a temperature reading without human input in the measurement process itself.
7. Type of Ground Truth Used
The "clinical accuracy evaluation" for a thermometer typically establishes ground truth by comparing the device's readings to a highly accurate and validated reference thermometer or core body temperature measurement method. While the document doesn't explicitly state the exact ground truth method, given the standard followed (ISO 80601-2-56:2009), it would involve comparison to a traceable temperature standard. It is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
The 510(k) summary does not provide information on the sample size for a training set. For a simple device like an infrared thermometer, there might not be a "training set" in the sense of machine learning. The device's calibration and potentially some internal lookup tables are likely based on engineering and design specifications rather than a distinct training dataset for an algorithm.
9. How Ground Truth for the Training Set Was Established
This information is not provided. As mentioned above, it's unlikely a "training set" with ground truth in the machine learning sense was used. The ground truth for device calibration would have been established through a metrology process using precise temperature standards.
§ 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.