(163 days)
The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body temperature in the ear cavity by thermal radiation for people of all ages except preterm babies and newborns (1-29 days old).
The YUWELL® Infrared ear thermometer is designed for measuring the body's temperature, is a hand-held non-contact infrared thermometer, battery powered, using the infrared energy emitted in the subject's tympanic membrane that converts a user's body temperature.
The provided document describes the safety and effectiveness of the YUWELL Infrared Ear Thermometer (Models YHT101, YHT200) based on comparisons to a predicate device (Braun Thermoscan® PRO 6000 Ear Thermometer) and compliance with various standards.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not present a formal table of "acceptance criteria" for the device, but rather compares the subject device's specifications and performance to a predicate device and states compliance with recognized standards. The "Performance" row in the "Substantial Equivalence" table (page 4) indicates the key performance standards met.
Here's a table based on the key performance and accuracy criteria mentioned:
| Acceptance Criteria (Standard Reference) | Reported Device Performance (YUWELL Infrared Ear Thermometer) | Comment/Predicate Comparison |
|---|---|---|
| Accuracy (ASTM E 1965, ISO 80601-2-56) | 34.0°C | |
| 35.0°C | ||
| 42.1°C | Same as predicate device for clinical measurement range. The document states: "For the normal clinical measurement range of 34.0°C to 42.2°C, the accuracy of the subject device and the predicate device are the same." Predicate accuracy: 0.3 °C for 42°C. | |
| Measurement Range | 34.0°C to 42.2°C (93.2°F ~ 108.0°F) | Slightly narrower than predicate. Predicate: 20°C to 42.2°C (68°F to 108.0°F). Justified as meeting normal clinical use and not bringing additional risks. |
| Electrical Safety | Meets IEC 60601-1 | Same as predicate. |
| EMC (Electromagnetic Compatibility) | Meets IEC 60601-1-2 | Same as predicate. |
| Biocompatibility | Meets ISO 10993-1, ISO 10993-5, ISO 10993-10 | Same as predicate. |
| Home Use (if applicable) | Meets IEC60601-1-11 | Not explicitly stated for predicate in the table, but the subject device meets this standard. |
| Software Verification & Validation | Meets FDA Guidance "Guidance for the content of premarket submissions for software contained in Medical Devices" | Not explicitly stated for predicate in the table, but the subject device meets this guidance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Clinical accuracy test requirements established in the standard ASTM E1965 (Clinical part only) and ISO 80601-2-56 (Clinical accuracy validation only)". However, it does not provide details on the specific sample size used for these clinical accuracy tests, nor does it specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that "Clinical accuracy test requirements established in the standard ASTM E1965 (Clinical part only) and ISO 80601-2-56 (Clinical accuracy validation only)" were met. For clinical thermometers, ground truth is typically established by comparing the device's readings against a highly accurate reference thermometer (e.g., rectal thermometry in controlled environments or other gold standard methods) in actual patients.
However, the document does not specify the number of experts used or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information regarding an adjudication method for establishing ground truth or evaluating the test set.
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
The device under review is an infrared ear thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that involves human "readers." Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not applicable and was not performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary performance evaluation described is for the standalone device (algorithm only, without human-in-the-loop performance beyond operating the device). The "Performance test according to ASTM E 1965 and ISO80601-2-56" and "Clinical accuracy test" directly assess the device's ability to accurately measure temperature on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical accuracy validation of a thermometer, the ground truth is typically established by comparison to a highly accurate reference method (e.g., a calibrated reference thermometer measuring core body temperature, often rectal or arterial temperature, in a controlled setting) as defined by the standards like ASTM E1965 and ISO 80601-2-56. The document mentions meeting these standards for clinical accuracy.
8. The sample size for the training set
The document does not provide information regarding a separate "training set" for the device. Clinical thermometers are calibrated and validated against standards; they don't typically undergo machine learning training in the same way an AI diagnostic device would.
9. How the ground truth for the training set was established
As there's no mention of a traditional machine learning "training set" in the context of this infrared ear thermometer, this question is not applicable. The device's internal algorithm is likely developed based on physics principles of infrared radiation and calibrated against known temperature sources, rather than being "trained" on a dataset with ground truth 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.