(81 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 and for use in the home. It is also available to detect object's surface temperature including human skin.
The 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 510(k) summary for the Fora ComfortScan Ear Thermometer offers limited detail regarding specific acceptance criteria and the comprehensive study design. However, based on the available information, here's a breakdown:
1. A table of acceptance criteria and the reported device performance
The submission states compliance with voluntary standards, which inherently include acceptance criteria for accuracy and performance. Without the full standard documents, specific numerical criteria are not explicitly given in this summary. However, we can infer some general performance reporting.
| Acceptance Criteria (Inferred from standards and predicate) | Reported Device Performance (as stated in the summary) |
|---|---|
| Compliance with ASTM E1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature) | "The results were compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC 60601-1 and IEC 60601-1-2 requirements." |
| Clinical acceptability of temperature differences and repeatability | "For clinical results, differences were within clinical acceptability and repeatability was statistically and clinically acceptable." |
| Accuracy within specified ranges (typically ±0.2°C or ±0.4°F for clinical thermometers within a certain range) | "differences were within clinical acceptability" and "repeatability was statistically and clinically acceptable." (Specific numerical values for accuracy and repeatability are not provided in this summary.) |
| Electrical safety and electromagnetic compatibility (EMC) requirements as per IEC standards | "compliance to applicable voluntary standards includes... IEC 60601-1 and IEC 60601-1-2 requirements." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The summary only mentions "clinical and non-clinical studies."
- Data Provenance: Not explicitly stated. Given the manufacturer's location (Taiwan), it's plausible the studies were conducted there, but this is an assumption. The summary does not specify if the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the summary. For a clinical thermometer, "ground truth" for temperature is typically established using a reference thermometer (e.g., a mercury-in-glass thermometer or a highly accurate electronic thermometer calibrated to national standards), not human experts in the way medical image analysis might.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for subjective assessments, such as interpreting medical images. For a device measuring a quantitative physical parameter like temperature, adjudication by multiple experts isn't usually applicable for establishing the ground truth measurements. The "ground truth" would be the reading from a calibrated reference thermometer.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading images) and the impact of AI assistance. A clinical thermometer measures a direct physiological parameter and does not involve human "readers" or AI assistance in its primary function for interpretation.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies performed (clinical and non-clinical) were inherently standalone in nature for the thermometer. The device itself measures temperature, and its performance is evaluated based on the accuracy and repeatability of those measurements compared to a reference standard, without human interpretation of its internal "algorithm." The results "were compliance to applicable voluntary standards" and "differences were within clinical acceptability and repeatability was statistically and clinically acceptable," indicating standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for temperature measurement would be established by comparison to a calibrated reference thermometer. While not explicitly stated, this is the standard practice for evaluating the accuracy of clinical thermometers, as dictated by standards like ASTM E1965-98. The summary refers to "clinical acceptability," which implies a comparison to a known, accurate temperature.
8. The sample size for the training set
This information is not applicable and therefore not provided. Clinical thermometers are typically hardware-based devices with firmware that executes a measurement algorithm. They don't typically undergo a "training" phase in the machine learning sense with a "training set." Performance is validated through testing on actual measurements.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" in the context of this device.
§ 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.