(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.
§ 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.