(64 days)
FORA ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.
FORA ComfortScan Ear Thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body.
The provided document describes the acceptance criteria and the study conducted for the FORA ComfortScan Ear Thermometer, model TD-1261A/B.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device was validated by tests according to ASTM E1965-98 and met the requirements of prEN12470-5:2000 standards. While specific numerical acceptance criteria (e.g., maximum allowed error) are not explicitly stated in the provided text, the reported performance is that the device met the requirements of these standards for various tests. For the clinical accuracy test, the performance metrics reported are "Clinical bias" and "Clinical repeatability."
| Item | Standard Complied | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Laboratory accuracy | ASTM E1965-98, prEN12470-5 | Met requirements of the standards for measurement error | Met the requirements of the standards; measurement error assessed |
| Clinical accuracy | ASTM E1965-98, prEN12470-5 | Met requirements of the standards for clinical bias & repeatability | Met the requirements of the standards; clinical bias and clinical repeatability assessed |
| Safety | IEC 60601-1 | Met safety requirements | Evaluated by ETC (testing laboratory) |
| Electromagnetic compatibility (EMC) | IEC 60601-1-2 | Met EMC requirements | Evaluated by ETC (testing laboratory) |
| Storage stability | ASTM E1965-98 | Met requirements for measurement error after storage | Met the requirements of the standard; measurement error assessed |
| Cleaning procedure test | ASTM E1965-98, prEN 12470-5 | Met requirements for measurement error after cleaning | Met the requirements of the standards; measurement error assessed |
| Shock test | ASTM E1965-98 | Met requirements for measurement error after shock | Met the requirements of the standard; measurement error assessed |
| Displayed temperature | ASTM E1965-98 | Met requirements for measurement error of displayed temperature | Met the requirements of the standard; measurement error assessed |
| Operating range | ASTM E1965-98, prEN12470-5 | Met requirements for measurement error across operating range | Met the requirements of the standards; measurement error assessed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in either laboratory or clinical accuracy studies. It only mentions that the device was validated according to ASTM E1965-98 and prEN12470-5:2000. These standards typically outline requirements for sample sizes, but the specific numbers used in this particular study are not provided in the summary.
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. Given that the device is a thermometer for measuring body temperature, the "ground truth" for clinical accuracy would typically involve a reference thermometer (e.g., a highly accurate hospital-grade rectal thermometer or a calibrated blackbody for laboratory testing), rather than expert interpretation of images or clinical findings that would require a panel of experts.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically relevant for studies involving subjective interpretations, such as medical imaging where multiple readers independently review cases and then reconcile their findings. For a device like an ear thermometer, which measures a physical quantity, this type of adjudication method is not applicable and therefore not mentioned in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which assesses how human readers improve with AI assistance, is not applicable to a standalone medical device like an ear thermometer. This device directly measures temperature without human interpretation of complex data or AI assistance in diagnostic tasks. Therefore, no such study was done or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone (algorithm only) device in the sense that it provides a direct temperature reading without requiring a human-in-the-loop for interpretation or modification of its core function. The performance assessment described (laboratory and clinical accuracy) evaluates the device's standalone capability to measure temperature. So, yes, the described performance characteristics are a standalone assessment of the device.
7. The Type of Ground Truth Used
For "Laboratory accuracy" and "Clinical accuracy" tests, the ground truth would typically be established using:
- Laboratory Accuracy: A highly accurate and calibrated reference thermometer or a blackbody temperature standard in a controlled laboratory setting.
- Clinical Accuracy: A reference body temperature measurement obtained from a primary site (e.g., rectal, oral) using a highly accurate and calibrated clinical reference thermometer, often performed by qualified medical personnel.
The document implicitly refers to these by stating compliance with ASTM E1965-98 and prEN12470-5:2000, which define how such ground truth is established for thermometer testing.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning or AI-based devices. As the FORA ComfortScan Ear Thermometer is an infrared sensor-based device that directly measures temperature and does not involve AI or machine learning algorithms that require a training phase, there is no training set in the conventional sense for this device.
9. How the Ground Truth for the Training Set Was Established
Since no training set is applicable for this device (as explained in point 8), the question of how its ground truth was established is not relevant.
§ 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.