(373 days)
Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-630, HA-640, HA-650) is a non-sterile, reusable, clinical thermometer intent determination of human body temperature in a touch and no touch mode using the center of the forehead as the measurement site on people of all ages. The devices are reusable for home use only.
The Infrared Forehead Thermometer (Models: HA-610, HA-630, HA-640, HA-640, HA-650) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted from the area around the user's forehead, to an oral equivalent temperature when placed within 1-5 cm to the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for ambient temperature readings.
It composed by a measuring sensor, set button, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-640, HA-650).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for clinical performance are derived from ISO 80601-2-56 and ASTM E1965-98 (2016). The document explicitly states that the device complied with the requirements of ISO 80601-2-56. Specific numerical acceptance criteria are directly mentioned for measurement accuracy.
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| Measurement Accuracy (Body) (ISO 80601-2-56 & ASTM E1965-98) | |
| ± 0.2°C (35.0 | ± 0.2°C (35.0 |
| ± 0.3°C (34.0 | ± 0.3°C (34.0 |
| Electrical Safety (IEC 60601-1, IEC 60601-1-11, ISO 80601-2-56) | Complied according to test report |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complied according to test report |
| Software Verification and Validation (FDA Guidance) | Complied according to test report |
| Biocompatibility (ISO 10993) | Complied (stated as SE to predicate, which also complied) |
| Performance (ISO 80601-2-56) | Complied according to test report |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 240 subjects.
- Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is Xiamen Ants Bro Technology Co., Ltd. in China, and the application correspondent is Guangzhou GLOMED Biological Technology Co., Ltd. in China. It is highly probable the study was conducted in China. The study appears to be prospective as it describes the conduct of "clinical tests."
3. Number of Experts Used to Establish the 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 the ground truth. It states that "clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO80601-2-56." This standard would typically dictate the methodology for ground truth establishment (e.g., using a reference thermometer).
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none). Given the nature of a clinical thermometer study, ground truth is typically established by physical measurement with a highly accurate reference device, rather than expert review requiring adjudication among multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-driven diagnostic imaging devices where human readers interpret cases with and without AI assistance. This submission concerns a clinical thermometer, which is a direct measurement device not involving human interpretation in the same manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical study performed for the Infrared Forehead Thermometer is a standalone performance evaluation of the device itself. The device takes a measurement independently, and its accuracy is compared against a reference standard. There is no "human-in-the-loop" component in the direct temperature measurement.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established by reference measurements as dictated by the ISO 80601-2-56 standard for clinical thermometers. This typically involves comparing the device's readings to those obtained from a highly accurate, calibrated reference thermometer. The document implies this by stating the study complied with ISO 80601-2-56.
8. The Sample Size for the Training Set
This information is not provided and is generally not applicable in the typical sense of AI/ML models. The Infrared Forehead Thermometer is a measurement device that functions based on physical principles (infrared radiation detection) and calibration, not on a "training set" of data in the way an AI algorithm learns. While the device's internal algorithms or calibrations might have been developed using some data, it's not structured as a distinct "training set" in the context of this regulatory submission.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and not applicable for the reasons mentioned in point 8. The ground truth for calibrating the device would be established through highly controlled laboratory measurements using known temperature sources and reference thermometers, following metrological 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.