(311 days)
The infrared thermometer is intended for the measurement and monitoring of human body temperature by doctors or customers in the hospital or at home.
EFT-16 series (Model: EFT-161, EFT-162, EFT-164, EFT-165, EFT-166) measure the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode, and ear temperature mode, directly show on the LCD screen. The device is widely used for home healthcare, medical institutes and many other occasions. The product is mainly composed with infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc. It focuses the infrared from the human's forehead or ear by the Fresnel lens.
The provided documentation describes the acceptance criteria and the study conducted for the Shenzhen Brav Electronic Technologies Co., Ltd. Infrared Thermometer models EFT-162, EFT-163, EFT-164, EFT-165, EFT-166.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate/standards) | Reported Device Performance (EFT-16 series) |
|---|---|---|
| Accuracy (Body Temperature) | Predicate: ±0.2°C / 0.4°F @ 35.5-42.0°C (95.9-107.6°F); ±0.3°C / 0.5°F @ 32.0-35.4°C (89.6-95.7°F) & 42.1-42.9°C (107.8-109.2°F) | Proposed Device: ±0.2°C (0.4°F) for the whole measurement range (32.0°C-42.9°C) |
| Measurement Range | 32.0°C ~ 42.9°C (89.6°F ~ 109.2°F) | 32.0°C ~ 42.9°C (89.6°F ~ 109.2°F) |
| Resolution of Display | 0.1°C/°F | 0.1°C/°F |
| Operating Environment | 10°C ~ 40°C (60.8°F to 95°F), RH 80% or below | 15°C ~ 35°C (59°F to 95°F) ≤85% moisture condensation |
| Storage Environment | -25°C ~ 55°C (-13°F to 131°F), RH 80% or below | -20°C ~ 55°C (-4°F ~ 131°F) ≤90% moisture condensation |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10 | Proposed Device: Tested per ISO 10993-5 and ISO 10993-10, demonstrating biocompatibility (for ABS and PE patient-contacting materials). Necessary testing included Cytotoxicity, Skin Sensitization and Irritation. |
| Electrical Safety & EMC | Compliance with ANSI/AAMI ES60601-1 and IEC 60601-1-2 | Proposed Device: Complies with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, and IEC 60601-1-2: 2014. |
| Bench Testing | Compliance with IEC 60601-1-11 and ISO 80601-2-56 | Proposed Device: Complies with IEC 60601-1-11: 2010 and ISO 80601-2-56: 2009. |
| Software V&V | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (FDA) | Proposed Device: Software verification and validation testing conducted, documentation provided. Software considered a "Moderate" level of concern. |
| Clinical Performance | Compliance with ASTM E 1965-98 Standard Specification For Infrared Thermometers For Intermittent Determination Of Patient Temperature | Proposed Device: Clinical testing conducted per ASTM E 1965-98. "Results show PASS for all test." |
Note on Accuracy: The proposed device actually reports a tighter accuracy range (±0.2°C across the entire measurement range) compared to the predicate device which had a wider tolerance (±0.3°C) at the extreme ends of its measurement range. This is presented as meeting the requirements of international standards ISO 80601-2-56:2019 and ASTM E 1965-98.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the clinical test set. It only mentions "Clinical testing is conducted per ASTM E 1965-98". ASTM E 1965-98 specifies requirements for clinical accuracy but does not dictate a fixed sample size. Typically, clinical studies for thermometers involve a certain number of subjects to demonstrate accuracy against a reference.
- Data Provenance: Not explicitly stated. The manufacturer is based in Shenzhen, China. The document does not specify if the clinical testing was conducted in China or another country, nor if it was retrospective or prospective. Given the device's intended use in both hospital and home settings, it would likely be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not mention the number of experts or their qualifications for establishing ground truth in the clinical testing. For a thermometer, ground truth is typically established by comparative measurements against a highly accurate reference thermometer (e.g., a laboratory standard thermometer or a rectal/oral mercury thermometer in a clinical setting) using established protocols, not expert consensus in the same way an imaging AI algorithm might be evaluated.
4. Adjudication Method for the Test Set
- The document does not mention any adjudication method for the clinical test set. Given the nature of a thermometer's performance evaluation (direct measurement comparison), an adjudication method in the context of multiple human readers/reviewers is generally not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging algorithms where human readers interpret images with and without AI assistance. This is not relevant for a clinical electronic thermometer.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, the performance evaluation for the Infrared Thermometer is inherently a standalone performance evaluation. The device itself performs the temperature measurement and displays the result. There is no "human-in-the-loop" component for its core function of temperature determination that would require a separate study to evaluate. The "clinical data" section describes testing the device's accuracy in measuring patient temperature.
7. Type of Ground Truth Used
- The ground truth for the clinical accuracy evaluation would be established by comparison against a reference standard in a clinical setting. ASTM E 1965-98 typically requires comparison of the device's readings with core body temperature measurements obtained using a validated, highly accurate reference thermometer (e.g., a standard mercury-in-glass thermometer or a highly accurate electronic reference thermometer) in a controlled environment, often involving simultaneous measurements. The document states "Clinical testing is conducted per ASTM E 1965-98 Standard Specification For Infrared Thermometers For Intermittent Determination Of Patient Temperature," which implies this method of ground truth establishment.
8. Sample Size for the Training Set
- The document does not provide information on a training set sample size. Infrared thermometers are typically calibrated and validated through engineering and clinical performance testing, not through machine learning model training in the same way an AI algorithm would be. While there might be firmware or algorithms for signal processing, the document does not describe a machine learning-based approach requiring a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a "training set" in the AI/machine learning sense, there is no information on how ground truth for such a set was established. Device calibration and internal processing logic are developed based on physics principles, sensor specifications, and empirical validation against known temperature references.
§ 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.