(195 days)
The infrared forehead thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except the age under the 1 year.
The HONSUN infrared forehead thermometer is designed for measuring the body's temperature, is a handheld non-contact infrared thermometer, battery powered, detecting the infrared energy emitted in the forehead area within 0-3 cm (exclude 0 cm) that converts to a body temperature. The measurement site is center of the forehead, while reference body site is the oral. It is intended to measure the temperature of human body in home and hospital. lt consists of thermopile sensor, printed circuit board, enclosure, button and liquid crystal display. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then displayed on the LCD screen in digital form. It will be automatically power off if left idle for 20 seconds.
The document describes the acceptance criteria and study proving the device meets them for the HONSUN infrared forehead thermometer LD-FT-100B.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Infrared Forehead Thermometer LD-FT-100B are primarily based on the international standard ISO 80601-2-56 for clinical thermometers and ASTM E 1965. The device's performance is demonstrated through testing against these standards.
| Acceptance Criteria | Reported Device Performance (LD-FT-100B) |
|---|---|
| Measurement Range | 32°C to 43°C (89.6°F to 109.4°F) |
| Accuracy (Temperature Ranges) | ±0.2°C (±0.4°F) in the range of 35.0°C |
| ±0.3°C (±0.5°F) in the range of 32.5°C | |
| Resolution of Display | 0.1°C/0.1°F |
| Operating Environment | 10°C (50°F) to 40°C (104°F), 15%RH ~90%RH (no condensation) |
| Storage Environment | -20°C (-4°F) to 55°C (131°F), 10%RH ~85%RH |
| Measurement Distance | Within 0-3 cm (exclude 0 cm) |
| Electrical Safety | Meets IEC 60601-1 |
| EMC (Electromagnetic Compatibility) | Meets IEC 60601-1-2 |
| Biocompatibility | Meets ISO 10993-1, ISO 10993-5, ISO 10993-10 |
| Clinical Accuracy | Met the requirements of ISO 80601-2-56 based on clinical testing |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Clinical Accuracy Test Set: 105 subjects in total.
- 40 people were older than 1 year and younger than 5 years (17 with fever).
- 65 people were older than 5 years (28 with fever).
- Clinical Accuracy Test Set: 105 subjects in total.
- Data Provenance: The details of the country of origin are not explicitly stated for the clinical accuracy test. However, given that HONSUN (Nantong) Co., Ltd is located in China, it is reasonable to infer the study was conducted there. The clinical accuracy test was conducted in September 2020, implying a prospective study design for this specific test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical accuracy test. It states that the YUWELL infrared thermometer YT-1 (the predicate device) was used as the reference device to establish the "ground truth" for temperature measurements in the clinical accuracy study. It implies comparison with a calibrated, legally marketed device rather than human experts interpreting results.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1). For the clinical accuracy test, the comparison was made against a reference thermometer (YUWELL infrared thermometer YT-1) by taking three measurements at the same site (forehead) alternately with the reference thermometer and the subject device. The ground truth was essentially the measurement reported by the reference device, as per the standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a thermometer, not an AI diagnostic tool that requires human interpretation. Therefore, a study comparing human readers with and without AI assistance is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the primary performance evaluation for the thermometer is its standalone accuracy and compliance with relevant standards (ISO 80601-2-56, ASTM E 1965) without human interpretation being part of the measurement process itself. The clinical accuracy test directly measured the device's performance against a reference.
7. The Type of Ground Truth Used
The ground truth used for the clinical accuracy study was established by comparison against a reference thermometer (YUWELL infrared thermometer YT-1), in accordance with the requirements of ISO 80601-2-56. This is a form of device-based ground truth, where a well-characterized and established medical device serves as the standard for comparison.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" as this device is a physical medical device, not a machine learning model that undergoes a training phase with data. The tests described are for validation and verification of the device's hardware and software performance.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for a machine learning model, this question is not applicable to the information provided. The device's design and operating principle are based on known physics of infrared detection and conversion, rather than learned patterns from a training dataset.
§ 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.