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510(k) Data Aggregation
(420 days)
The Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is an electronic thermometer using an infrared sensor to detect human body temperature from forehead on people of one month old and above. The device is reusable for home and clinical use.
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead. Its operation is based on measuring the natural thermal radiation from central forehead.
The thermometers use 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, and an infrared distance sensor for detection of no-contact use and compensation of the temperature reading.
The device mainly consists of infrared sensor, microprocessor, embedded software (Identified Software version is No: V1), memory, electro-acoustic components, LED display and the device is powered by 2AAA alkaline batteries.
The non-contact infrared thermometer included WL-301, WL-501, WL-601, WL-701. They can be selected calibration mode, body temperature mode and surface mode.
Here's a breakdown of the acceptance criteria and study information for the Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) | Notes/Differences |
|---|---|---|
| Measurement Range: 34°C ~ 43°C | Measurement Range: 34°C ~ 42°C | Different, but stated to meet ISO 80601-2-56:2017/Amd.1:2018 |
| Accuracy: | Accuracy: | |
| ±0.2°C: 35.0°C ~ 42.0°C | ±0.3°C: 34°C~42°C | Different, but stated to meet ISO80601-2-56 and demonstrated through clinical trial |
| ±0.3°C: 34.0°C ~ 34.9°C, 42.1°C ~ 43°C | ||
| Response time: 1S | Response time: |
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(127 days)
The Non-Contact Infrared Thermometer, Models JXB-315, JXB-320, JXB-311, is a non-sterile, reusable, handheld device. It can be used by consumers in household environment and doctor in clinic as reference. It is intended for non-contact measuring of human body temperature of people of all ages (neonate, infant, pediatric, adult) by detecting infrared heat from the center of the forehead.
The Non-contact Infrared Thermometer (include models JXB-315, JXB-320, JXB-311) is a hand-held forehead thermometer, and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature of human body which measures the body temperature based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages. The thermometer is also intended to measure the object temperature. After measurement, the temperature is directly displayed on the LED screen. These thermometers have the following features: 1) Body temperature mode 2) Fahrenheit and Celsius temperature unit setting LED display screen with automatic range selection, resolution is 0.1 degree Celsius (0.1 degree Fahrenheit) 3) 4) Memorize the latest 32 measurement data LED display screen 5) 6) Low battery indication 7) Measurement distance indication 8) Over range prompt (HI/LO) 9) Auto shutdown when the device is idle for 30 seconds 10) High temperature indication
The provided document describes the acceptance criteria and a clinical study conducted for the Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document references compliance with specific standards for measurement accuracy rather than explicitly stating numerical acceptance criteria. However, it does compare the subject device's declared accuracy with the predicate device and relevant standards.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Subject Device) |
|---|---|
| Measurement Accuracy (Body Temperature Mode): ASTM E1965-98 and ISO 80601-2-56 standards (range-specific accuracies) | Within the range of $34.0°C$ to $43.0°C$, the accuracy is the same as the predicate device ($±0.2°C$ for $35.0°C-42.0°C$, $±0.3°C$ for edges). For $32.0°C-34.9°C$, it is $±0.3°C$. Verified to comply with ASTM E1965-98 and ISO 80601-2-56. |
| Clinical Accuracy (Clinical Bias and Repeatability): Acceptance criteria of the clinical validation protocol based on ISO 80601-2-56:2017+AMD2018. | Clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol. |
| Electromagnetic Compatibility (EMC): IEC 60601-1-2:2014 | Passed |
| Electrical Safety: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, IEC 60601-1-11:2015 | Passed |
| Biocompatibility: ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2010 (irritation and skin sensitization) | Passed (demonstrated no potential toxicity, skin sensitization, and skin irritation) |
| Software Verification and Validation: Consistent with moderate level of concern. All software requirement specifications met, and hazards mitigated. | Passed |
2. Sample size used for the test set and the data provenance
- Sample Size: 150 subjects for the clinical accuracy validation.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation," which implies prospective data collection for the purpose of the validation.
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 for establishing ground truth in the clinical study.
4. Adjudication method for the test set
The document does not specify an adjudication method for the test set.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a standalone thermometer, and the study focused on its accuracy in measuring body temperature, not on assisting human readers with interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done for the device itself to measure its accuracy against established standards. The section "Clinical Accuracy Validation" specifically details how the device's readings were validated against clinical ground truth.
7. The type of ground truth used
The ground truth for the clinical accuracy validation was based on clinical measurements performed on subjects, implicitly alongside a reference method (though the reference method is not explicitly named, it's standard practice in such studies to compare against a highly accurate clinical thermometer). The study assessed "clinical bias and clinical repeatability" against this ground truth.
8. The sample size for the training set
The document does not mention a training set because this is a hardware medical device (a thermometer), not an AI/machine learning algorithm that typically requires a distinct training phase.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for this hardware device.
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(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.
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