(308 days)
Non-contact Infrared Thermometer 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 two months and above of people by detecting infrared heat from the center of the forehead.
The thermometer measures the temperatures of people by detecting the energy. The external probe plays an important role in the measuring process. As soon as the thermometer is placed at the center of the forehead or the object with a distance of 15mm-50mm and the radiation sensor is activated, the measurement will be taken instantly by detection of the infrared heat.
The thermometer AET-R161 can be connected with FOND APP through Bluetooth. The FOND APP applies to mobile phones which systems are Android 4.3 and above, or IOS 8.0 and above, and can be downloaded from Google store (for Android 4.3 and above) or iPhone APP Store (for IOS 8.0 and above). The data measured with AET-R161 can be transmitted to the FOND APP, where data can be recorded, saved and shared.
The device principle of operation is described as below:
All object, solid, liquid or gas, emit energy by radiation. The intensity of this energy depends on the temperature of the object. The Infrared Thermometer is therefore able to measure the temperature of a person by the energy the person emits. This measurement can be taken by an external temperature probe on the device for analysis and register the ambient temperature. Therefore, as soon as the operator holds the thermometer near forehead and activates the radiation sensor, the measurement is taken instantly by detection of the infrared heat generated by the arterial blood flow. Body heat can therefore be measured without any interference from the heat of the surrounding environment.
The thermometer includes four models: AET-R161, AET-R171, AET-R1D2, AET-R1B1. They all have the following basic functions:
- Sound alarm if the temperature exceeds 37.8℃.
- LCD back-lighted digital screen.
- Data displayed in Celsius or Fahrenheit.
- Automatic stop (energy saver).
This document describes the regulatory submission for a Non-contact Infrared Thermometer (Models: AET-R161, AET-R171, AET-R1D2, AET-R1B1) seeking substantial equivalence to a predicate device. The information provided is primarily focused on non-clinical and clinical performance testing to demonstrate that the device meets established standards for accuracy and safety.
Here's an analysis of the provided information, framed as acceptance criteria and proof, as well as limitations based on the document's content:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds for each metric alongside the reported performance. However, it implicitly defines acceptance by stating compliance with various international standards, particularly for performance and safety. The key performance criterion for a thermometer is its accuracy.
Implicit Acceptance Criteria (based on standards) and Reported Performance:
| Acceptance Criteria (based on Standard Compliance) | Reported Device Performance |
|---|---|
| Measuring Accuracy: $\pm0.2°C (\pm0.4°F)$ within clinical range (forehead mode based on predicate) | Forehead measurement mode/Body mode: $\pm0.2°C (\pm0.4°F)$ |
| Measuring Range: Minimum rated output range of clinical thermometer (35°C to 42°C) as per ISO 80601-2-56 | Forehead measurement mode/Body mode: 32.0°C to 42.2°C (89.6°F to 108°F) (meets/exceeds min. requirement) |
| Display Resolution: $0.1°C (0.1°F)$ | $0.1°C / 0.1°F$ |
| Electrical Safety: Compliance with IEC 60601-1, IEC 60601-1-11, ISO 80601-2-56 | Passed |
| EMC: Compliance with IEC 60601-1-2 | Passed |
| Biocompatibility: Compliance with ISO 10993-5, ISO 10993-10 | Passed |
| Cleaning/Disinfection Validation: Compliance with ASTM E2314-03(2014) | Passed |
| Software Validation: Compliance with FDA Guidance for Software Contained in Medical Devices | Passed |
| Wireless Coexistence (for Bluetooth model): Compliance with 47 CFR PART 15 Subpart C | Passed |
Study Details Proving Device Meets Acceptance Criteria
The primary study cited for clinical performance is the clinical accuracy validation conducted according to ASTM E1965-98 (2009).
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Infants (two months to 1 year old): 38 subjects
- Children (1 up to 5 years old): 36 subjects
- Adults (older than 5 years): 42 subjects
- Total Sample Size: 38 + 36 + 42 = 116 subjects
- Data Provenance: The document does not explicitly state the country of origin. It is presented as a general clinical study. It is a prospective clinical accuracy test as it involves testing a device on live subjects to determine its performance characteristics.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide details on the number of experts or their specific qualifications for establishing ground truth. However, the ground truth for human body temperature in a clinical accuracy study (like ASTM E1965-98) would typically be established by highly accurate, often invasive, reference thermometers (e.g., rectal thermometers) operated by trained medical professionals (e.g., nurses, doctors). The "RCT (model: WDJ-001)" mentioned for the clinical study likely refers to a Reference Clinical Thermometer.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method. For a direct clinical accuracy study comparing a device's reading to a reference standard, "adjudication" in the sense of expert consensus on ambiguous cases is generally not applicable, as the "ground truth" is a direct measurement from a validated reference instrument.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study was not performed. This device is a non-contact infrared thermometer, which directly measures temperature. Its performance is evaluated against a reference thermometer, not by human readers interpreting images or data. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes. The primary clinical accuracy study described assesses the standalone performance of the thermometer (the algorithm/device itself) in measuring temperature against a reference standard. While a human operates the device, the performance being evaluated is the device's accuracy in autonomously generating a temperature reading.
7. Type of Ground Truth Used
The ground truth used is based on direct measurements from a reference clinical thermometer (model: WDJ-001) in live human subjects across different age groups. This is a direct measurement ground truth, considered highly reliable for temperature measurement studies.
8. Sample Size for the Training Set
The document does not provide any information about a specific training set. Medical devices undergoing 510(k) clearance, especially non-AI based devices like a thermometer, typically rely on fixed algorithms and calibration rather than machine learning models that require training data. If any internal calibration or development was done, the data used for that is not disclosed here.
9. How the Ground Truth for the Training Set was Established
As no training set is described in the context of machine learning, this question is not applicable based on the provided document. The device's calibration and performance are validated against physical standards and clinical studies, rather than "training" an AI model.
§ 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.