(273 days)
The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.
Infrared Body Thermometer, model: HTD8222US, is a hand-held, battery powered, infrared thermometer that measures human body temperature through the opening of the auditory canal or on forehead, by measuring the infrared energy emitted in the area around the user's forehead or tympanic membrane and adjacent surfaces when placed within 1~5 centimeter of the subject's forehead or insert into auditory canal. The Infrared Body Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead or tympanic membrane and the adjacent surfaces for detection of non-contact use and contact use and compensation of the temperature reading.
The Infrared Body Thermometers measure temperature by pressing the On/Scan 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 device can measure temperature with three modes, forehead scan mode and ear mode.
Both forehead mode and forehead scan mode modes are non-contact with human body and measure forehead temperature. The forehead mode measures temperature from middle of the forehead, forehead scan mode measures temperature by scan the forehead from left to right or from right to left with position light spot following within approximately 3~10 seconds, then the maximum temperature will display on the screen.
The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. After removing the probe covering cap, the small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues emit IR radiation.
The provided text describes the acceptance criteria and the study conducted for the Infrared Body Thermometer, Model: HTD8222US.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Reference) | Reported Device Performance (HTD8222US) |
|---|---|
| Measuring Accuracy (ASTM E1965-98) | ±0.2°C (0.4°F) within 35 |
| ±0.3°C (0.5°F) for 34.0°C ~ 34.9°C and 42.1°C ~ 43.0°C | |
| Clinical Accuracy (Forehead Mode) (Calculated per ASTM E:1965-98) | Clinical bias: 0.14°C/0.15°C/0.15°C with Uncertainty: ±0.14/ ±0.15/ ±0.14 for group I/II/II. Clinical repeatability: 0.12 °C |
| Clinical Accuracy (Forehead Scan Mode) (Calculated per ASTM E:1965-98) | Clinical bias: 0.16°C/0.15°C/0.14°C with Uncertainty: ±0.10/ ±0.09/ ±0.09 for group I/II/II. Clinical repeatability: 0.12 °C |
| Clinical Accuracy (Ear Mode) (Calculated per ASTM E:1965-98) | Clinical bias: 0.12 °C/0.10/0/10 with Uncertainty: ±0.12 °C/ ±0.14 °C/ ±0.14 °C for group I/II/II. Clinical repeatability: 0.12 °C |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Meets ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization) |
| Electrical Safety (ANSI AAMI ES60601-1) | Complied |
| EMC (IEC 60601-1-2) | Complied |
| Performance (ISO 80601-2-56) | Complied |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 140 subjects.
- Data Provenance: The document does not explicitly state the country of origin. It indicates that the clinical investigation report and data analysis followed the requirements of ASTM E1965-98 (2016). It also mentions that the submitter is based in DongGuan City, Guangdong, China. Given this information, it is highly probable the study was conducted retrospectively in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide details on the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish the ground truth for the clinical accuracy testing. It only states that the "clinical investigation report and data analysis followed the requirements of the ASTM E 1965-98 (2016)."
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance of the infrared thermometer and its comparison to standards, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done. The document describes the clinical accuracy testing of the device itself (Infrared Body Thermometer, Model: HTD8222US) in various modes (forehead, forehead scan, ear) against the requirements of ASTM E1965-98 (2016). This evaluates the algorithm's performance in taking temperature measurements.
7. The Type of Ground Truth Used:
The ground truth for the clinical accuracy testing was established based on the requirements of ASTM E1965-98 (2016), which is a standard specification for infrared thermometers for intermittent determination of patient temperature. This implies a comparison to a reference temperature measurement method, likely a highly accurate clinical thermometer, to determine the bias and repeatability of the device.
8. The Sample Size for the Training Set:
The document does not specify a separate "training set" or its sample size. The description of clinical accuracy testing refers to a "test set" of 140 subjects. For medical devices like thermometers, it is common for the "training" (calibration and development) to be conducted internally by the manufacturer, and the regulatory filing focuses on the validation (test) phase.
9. How the Ground Truth for the Training Set was Established:
As no specific training set is mentioned, the method for establishing ground truth for a training set is not detailed in the provided information. However, the overall development and calibration of such a device would likely follow internal standards and involve rigorous testing against known temperature sources and potentially clinical reference thermometers to ensure accuracy and precision.
§ 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.