(247 days)
The infrared forehead thermometer is non-sterile, reusable, non-contact and handheld device for the intermittent measurement and monitoring of human body temperature from the center of the forehead from a measurement distance of 3-5 cm. It can be used by consumers in homecare environment and doctors in clinic. It is intended for measuring human body temperature of people of all ages.
The infrared forehead thermometer, Model of QY-EWQ-02 is a hand-held, battery powered IR thermometer. It is intended to measure the temperature of human body from forehead without contact to human body. It is indicated for use by people of all ages in the home. The infrared forehead thermometer has the following features: 1) This device can be used for measuring the forehead temperature; 2) Body and object temperature switching 3) Two temperature unit conversion, °C or °F; 4) LCD display with backlight; 5) Automatic range selection; resolution is 0.1℃ (0.1℃F) 6) The latest 20 measurement data can be memorized and stored; Three color backlight display (Red, Orange, Green); 7) 8) Low battery detection; Turn on/off the prompt tone; 9) 10) High temperature alarm limit setting; 11) Ambient temperature detection; 12) Malfunction indication; 13) Low and high temperature alarm
Here's an analysis of the provided text regarding the Infrared Forehead Thermometer (Model QY-EWQ-02).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the infrared forehead thermometer are primarily based on established international standards for clinical thermometers. The performance claims for the subject device are listed in comparison to a predicate device.
| Acceptance Criteria (from Standards) | Reported Device Performance (Subject Device K201536) |
|---|---|
| Measurement Accuracy: | Clinical Accuracy (ASTM E1965-98): |
| Clinical bias and clinical repeatability met the acceptance criteria of the clinical study protocol. | |
| Bench Accuracy: ±0.2 °C (32.0°C ~ 43.0 °C); ±0.4 °F (89.6°F~109.4°F) | |
| Clinical Repeatability: | ≤0.2 °C (0.4 °F) |
| Measurement Range: | 32.0°C |
| Display Resolution: | 0.1°C ( 0.1°F) |
| Measurement Time: | ≤ 1 second |
| Biocompatibility: | Passed ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) |
| Electrical Safety: | Passed IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 |
| Performance (General): | Passed ISO 80601-2-56:2017+AMD2018 and ASTM E1965-98 (Reapproved 2016) Bench Testing |
Study Proving Device Meets Acceptance Criteria:
A clinical accuracy validation study was conducted according to ASTM E1965-98 (Reapproved 2016). This study demonstrated that the clinical data, represented by clinical bias and clinical repeatability, met the acceptance criteria defined in the clinical study protocol.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 150 subjects.
- 50 infants (newborn to one year)
- 50 children (greater than one to five years)
- 50 adults (greater than five years old)
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It is a "randomization, simple blind homologous control, pairing design of clinical investigation," which implies a prospective study.
3. Number of Experts and Qualifications for Ground Truth of Test Set
The document does not provide details on the number of experts used to establish the ground truth or their specific qualifications for the clinical study referenced in section 8. For thermometer accuracy studies, ground truth typically involves a highly accurate reference thermometer measurement, often taken rectally or orally, which would be performed by trained medical staff.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set. The study is described as a "simple blind homologous control, pairing design," which focuses on comparing the device's readings to a reference standard rather than an expert consensus process requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes a clinical accuracy validation study for a medical device (thermometer), not an AI-powered diagnostic tool that would typically involve human readers. Therefore, an MRMC study and a human reader improvement effect size are not applicable in this context.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was conducted. The "Clinical Accuracy Validation Study" (Section 8) and "Performance Test-Bench" (Section 7.3) directly assess the device's performance based on its inherent functionality, without human interpretation or intervention in the temperature measurement itself. The device measures and displays a temperature value.
7. Type of Ground Truth Used
The ground truth used for the clinical accuracy validation study would have been established by a reference clinical thermometer measurement (e.g., rectal or oral temperature) known for its high accuracy, as is standard practice in ASTM E1965-98. The document states the study "met the acceptance criteria of the clinical study protocol," which inherently relies on comparison to a gold standard of temperature measurement.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This device is an infrared thermometer, which is a hardware device with embedded firmware/software for measurement and display, rather than a machine learning or AI algorithm that typically requires a large training dataset. The "Software Validation" mentioned in Section 7.4 refers to standard software engineering validation practices, not machine learning model training.
9. How Ground Truth for the Training Set Was Established
As no training set is discussed or implied for an AI/ML algorithm, this question is not applicable. The device's functionality is based on established physics and pre-programmed algorithms, validated against physical standards and clinical performance, not by learning from a training dataset in the AI sense.
§ 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.