(168 days)
The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature via the human ear. Operation is based on the measuring of the natural thermal infrared radiation emitted from the ear tympanic.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance Criteria (Predicate Device K103800) | Reported Device Performance (Thermo Pal ETH-101) |
|---|---|---|
| Measured Temperature Range | 34°C | 32 |
| Operating Ambient Temperature | 10°C~40°C | 10°C~40°C |
| Storage Ambient Temperature | -20°C~50°C | -20°C~50°C |
| Accuracy | ±0.2°C (0.4°F) for 36.0°C-39.0°C (96.8°F-102.2°F); ± 0.3°C (0.5°F) outside this range | ±0.2°C, 36 |
| Resolution | 0.1°C / 0.1°F | 0.1°C / 0.1°F |
2. Sample size used for the test set and data provenance:
The document mentions "A Clinical Test Report conducted according to ASTM E1965: 2003" but does not specify the sample size used for the test set.
The data provenance is described as "conducted by manufacturer," suggesting it was conducted by Digio2 International Co., LTD. The country of origin of the data is not explicitly stated, but the manufacturer is based in Taipei Hsien, Taiwan. The study appears to be prospective as it was "carried out in such a way that compared the accuracy performance between Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) and the predicate device."
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth in the clinical test.
4. Adjudication method for the test set:
The document does not specify any adjudication method used for the test set.
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. The device described is an infrared ear thermometer, which is a standalone measurement device and does not involve human readers or AI assistance in the context of diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance test was done, as the device is an infrared ear thermometer. The "Clinical Test Report" assessed the device's accuracy against a predicate device without human-in-the-loop performance.
7. The type of ground truth used:
The type of ground truth used for checking the accuracy of the Thermo Pal Infrared Ear Thermometer was comparison with a predicate device (BRAUN THERMOSCAN IRT 4000 series). Specifically, the report "compared the accuracy performance between Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) and the predicate device according to the method recommended in ASTM E1965 standard." This implies that the predicate device's readings served as the reference or "ground truth" for comparison.
8. The sample size for the training set:
The document does not mention a training set as this device is a hardware measurement instrument and not an AI/machine learning algorithm that requires training data.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of 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.