(156 days)
The Belter Infra-red Ear thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.
The Belter Infra-red Ear Thermometer is characterized by measuring human body temperature from the ear canal. It utilizes infrared technology to measure infrared energy emitted from eardrum tissue when making a temperature measurement.
This document describes the acceptance criteria and study results for the Belter Infra-red Ear Thermometer.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Value (ISO80601-2-56) | Reported Device Performance |
|---|---|---|
| Laboratory Accuracy (bench) | ≤ 0.2 ℃ | 0.01 ~ 0.19 ℃ |
| Clinical Repeatability | ≤ 0.3 ℃ | 0.07 ~ 0.11 ℃ |
| Structural Integrity | Meets requirements | Meets requirements |
2. Sample Size and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "bench test report" and "clinical repeatability."
3. Number of Experts and Qualifications
This information is not provided in the document.
4. Adjudication Method
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a thermometer, not an AI-assisted diagnostic tool.
6. Standalone Performance
Yes, a standalone performance assessment was done, evaluating the device's accuracy and repeatability without human intervention. The reported values for laboratory accuracy and clinical repeatability are standalone metrics.
7. Type of Ground Truth Used
The ground truth for accuracy was established against a reference standard in laboratory settings (bench tests) and through clinical repeatability measurements in a clinical setting. The specific method for determining the "true" temperature for comparison during clinical repeatability is not detailed, but it typically involves comparison to another validated thermometer or a set protocol.
8. Sample Size for Training Set
This information is not applicable as this is not an AI/ML device requiring a training set.
9. How Ground Truth for Training Set Was Established
This information is not applicable as this is not an AI/ML device requiring a training set.
§ 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.