(90 days)
The 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 for home and professional use.
FORA ComfortScan 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.
Here's a summary of the acceptance criteria and the study details for the FORA ComfortScan Ear Thermometer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Expanded Intended Use: To include home and professional settings. | Met: The device demonstrated safety and effectiveness for both home and professional use in lab and clinical accuracy reports. |
| Performance Equivalency to Predicate Device: Maintain the same performance characteristics as the predicate device (FORA ComfortScan Ear Thermometer, model TD-1261). | Met: The device exhibited the same performance characteristics as the predicate device, supported by lab and clinical accuracy reports. |
| Safety and Effectiveness: Demonstrate safety and effectiveness for the modified indications. | Met: Software verification and validation, along with risk analysis tests for user population changes, confirmed the performance, safety, and effectiveness. |
Study Details:
The provided text describes a 510(k) summary for a modified medical device. The primary objective of the submission is to demonstrate substantial equivalence to a previously cleared predicate device, the FORA ComfortScan Ear Thermometer, model TD-1261 (K081445).
2. Sample Size Used for the Test Set and Data Provenance
- The document states: "The performance of the FORA ComfortScan Ear Thermometer in the lab and clinical accuracy report demonstrated that the meter is safe and effective for home and professional use."
- Sample Size: The specific sample size for the test set (clinical accuracy report) is not provided in the given text.
- Data Provenance: The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated. However, considering it's a 510(k) submission to the FDA, the clinical data would typically adhere to recognized standards for clinical accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The text refers to "clinical accuracy report" but does not detail the methodology for establishing ground truth or the involvement of experts in that process.
4. Adjudication Method for the Test Set
- The adjudication method is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- This is not applicable to this device. The FORA ComfortScan Ear Thermometer is a standalone device for measuring body temperature and does not involve human readers for interpretation, nor does it incorporate AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this is a standalone performance study from the perspective of how the device operates. The thermometer itself provides the temperature reading directly, without human interpretation for the measurement output. The "clinical accuracy report" would assess the device's ability to accurately measure temperature on its own.
7. The Type of Ground Truth Used
- While not explicitly stated, for a clinical thermometer, the ground truth for accuracy studies typically involves simultaneous measurements using a highly accurate reference thermometer (often a rectal thermometer or a standardized probe in a controlled environment) or comparison to other clinically accepted temperature measurement methods. The document mentions "lab and clinical accuracy report," which implies comparison against a reliable standard.
8. The Sample Size for the Training Set
- This information is not provided in the document. The device uses infrared technology, which traditionally relies on established physics principles and calibration rather than a machine learning "training set" in the conventional AI sense. The "training set" concept is not relevant here for device function.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no mention or indication of a "training set" in the context of machine learning for this device. The device's operation is based on physical principles of infrared detection. Its accuracy would be established through calibration and validation against known temperature standards.
§ 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.