(277 days)
Infrared Thermometer (model: STM-20) is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
Infrared Thermometer (model: STM-20) is a hand-held, battery powered, non-contact infrared thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead, to an oral equivalent temperature when placed within 1-3 cm from the subject's forehead with no contact. The Infrared Thermometer referenced body site is oral temperature. The laboratory accuracy of rated output temperature range 34°C-42°C (93.2°F to 107.6°F) is ±0.2°C (0.4°F). The rated extended output range is 32°C33.9°C (89.6°F to 93.0°F), 42.1°C43°C (107.8°F to 109.4°F) and the laboratory accuracy is ±0.2°C (0.4°F) as well. The device can be used in the hospital or at home.
It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
It composed by a measuring sensor, PCB, 3 buttons, a LCD and an enclosure. Press the measurement key to turn on the device. The screen of the device lights up. The LCD screen has the power symbol, measurement mode, temperature unit and measurement temperature. When measuring body temperature, users need to keep the measurement distance 1-3 cm from the subject's center of forehead with no contact. Press the measuring key, after 1 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 30±5 seconds.
User contacts components are the enclosure and keys. The materials of the components are ABS plastic and it no any color additives.
The provided document describes the 510(k) summary for the Infrared Thermometer (Model: STM-20). This type of document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
The acceptance criteria for this device are primarily related to its accuracy in measuring body temperature and its compliance with relevant safety and performance standards. The study proving the device meets these criteria is a clinical performance test.
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance (Reference) |
|---|---|
| Accuracy (Laboratory) | |
| Temperature Range: 34°C-42°C (93.2°F to 107.6°F) | ±0.2°C (0.4°F) (Section 4) |
| Extended Range: 32°C~33.9°C (89.6°F to 93.0°F) | ±0.2°C (0.4°F) (Section 4) |
| Extended Range: 42.1°C~43°C (107.8°F to 109.4°F) | ±0.2°C (0.4°F) (Section 4) |
| Display Resolution | 0.1°C/0.1°F (Section 6) |
| Clinical Performance | |
| Compliance with ASTM E1965-98 (2016) | Complied (Section 7.2) |
| Safety and Essential Performance | |
| Electrical Safety (ANSI AAMI ES60601-1, IEC 60601-1-11) | Evaluated (Section 7.1) |
| Electromagnetic Compatibility (IEC 60601-1-2) | Evaluated (Section 7.1) |
| Software Verification and Validation (FDA Guidance) | Evaluated (Section 7.1) |
| General Requirements for Clinical Thermometers (ISO 80601-2-56) | Evaluated (Section 7.1) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 240 subjects were evaluated in the clinical performance test (Section 7.2).
- Data Provenance: Not explicitly stated regarding country of origin. The document is submitted by a company in China (Dongguan Prestige Sporting Goods Co., Ltd) with an application correspondent in China (Guangzhou GLOMED Biological Technology Co., Ltd.). The test standards (ASTM E1965-98) are international. The study is a prospective clinical performance test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications used to establish ground truth. For clinical thermometers, ground truth for temperature measurement is typically established using a highly accurate reference thermometer (e.g., a rectal or oral thermometer depending on the standard's requirements for a "core" temperature measurement) or a blackbody calibrator for laboratory accuracy. The document mentions the clinical performance test protocol and data analysis were conducted in accordance with ASTM E1965-98 (2016), which outlines how temperature measurements should be taken and compared.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method as it pertains to expert reviews of results. For clinical thermometer studies, the "ground truth" is typically a direct measurement from a highly accurate reference device, not a subjective interpretation requiring adjudication.
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
No. This device is a simple temperature measurement device, not an AI-assisted diagnostic imaging tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an infrared thermometer, which is inherently a standalone device in its core function of measuring temperature. Its performance is evaluated based on its accuracy against known standards and other temperature measurement methods, which effectively means its "algorithm" (i.e., its internal electronics and thermopile sensor) performance is tested directly. There isn't a separate "human-in-the-loop" aspect to its primary function of temperature reading.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical performance test was established based on the requirements of ASTM E1965-98 (2016). For these types of devices, ground truth is typically a direct measurement from a highly accurate reference thermometer. While not explicitly stated to be "rectal" or "oral" temperatures, ASTM E1965-98 typically mandates such comparisons for clinical accuracy.
8. The sample size for the training set
The document does not mention a "training set" because this is not a machine learning/AI device that requires a training phase. The device is a hardware product that directly measures infrared heat.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.