(106 days)
The Infrared thermometers (AOJ-20A and AOJ-20B) take human body temperature via the eardrum or forehead. They apply to all age groups except for babies under three months. Both devices apply to both professional use and home use.
The infrared thermometers (AOJ-20A and AOJ-20B) are handheld instruments, which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The intended patient population is all age groups except for babies under three months. The thermometers are powered by AAA 1.5V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of the forehead, which is converted into temperature measurement with the unit of °C or °F. It is mainly composed with infrared sensor, signal receiving processor, buttons, buzzer, LCD display, battery and etc.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ASTM E 1965-98) | Device Performance |
|---|---|
| Clinical accuracy of the subject device is at least the same as that of the reference device. | Demonstrated to be at least the same as the reference. |
| Accuracy is ±0.2℃ within the claimed measurement range of 32℃ - 42.9℃. | Achieved ±0.2℃ within the specified range. |
| No single measurement error exceeding the allowable limit. | Achieved (implied by 99% confidence and accuracy claim). |
2. Sample size used for the test set and the data provenance
- Sample Size: Minimum of 90 subjects.
- Composition: 1/3 children (greater than one to five years), 2/3 adults (greater than five years old).
- Data Provenance: Not explicitly stated, but it's a "clinical investigation" meaning prospective. The country of origin is not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the text. The study describes a "reference device" being introduced as required by the standard, implying that the ground truth is established by this reference device, not by expert consensus in the typical sense for subjective assessments.
4. Adjudication method for the test set
This information is not provided in the text. The study describes a "randomization, simple blind homologous control, pairing design of clinical investigation" but does not detail any adjudication specific to discrepancies.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an infrared thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting output.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the study described is a standalone performance study of the infrared thermometer. The thermometer directly provides a temperature reading, and its accuracy is compared against a reference device, without human interpretation of the device's output influencing the performance metrics.
7. The type of ground truth used
The ground truth for the clinical study was established by a reference device, as required by ASTM E 1965-98. The reference device's measurements serve as the comparator for the subject device's accuracy.
8. The sample size for the training set
This information is not applicable/not provided. Infrared thermometers like the AOJ-20A and AOJ-20B are typically designed and calibrated based on physics and engineering principles, not through machine learning models that require a "training set" of data in the same way an AI algorithm would.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the reasons stated in point 8.
§ 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.