(165 days)
The Infrared Ear thermometer is intended for the intermittent measurement of body temperature from the ear canal on people of all ages except for babies under 3 months. It is suitable for home use and healthcare facilities use.
The iHealth PT5 Infrared Ear Thermometer is a hand-held, reusable, battery operated device, which can measure human body temperature on one's ear canal. Its operation is based on measuring the natural thermal radiation from the ear canal with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. Put the probe of the thermometer into a patient's ear canal, after a self-check, pressing the activation button to start the measurement of proposed infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LED display. It is recommended that adult take the measurement instead when infants and children cannot use the ear thermometer themselves.
The iHealth PT5 Infrared Ear Thermometer measures body temperature from the ear canal. The device's performance was evaluated through non-clinical and clinical tests to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (from ASTM E1965-98 & ISO 80601-2-56) | Reported Device Performance (iHealth PT5) |
|---|---|---|
| Accuracy for body temperature measurement | ±0.2°C (0.4°F) within 35.5°C | Meets ASTM E1965-98 and ISO 80601-2-56 requirements. Specifically: ±0.4°F (0.2°C) within 93.2 |
| Repeatability | 5 years) |
The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. However, based on the testing being conducted to international standards (ASTM and ISO), it is likely to be a prospective clinical study specifically designed for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not explicitly provided in the document. The document states "Clinical accuracy validation test report included temperature readings," implying that a reference standard temperature measurement (often oral or rectal temperature by trained clinicians) was used as the ground truth, but the number or qualifications of experts involved in establishing this ground truth are not detailed.
4. Adjudication Method for the Test Set:
This information is not explicitly provided in the document.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
This type of study is not applicable here as the device is an infrared ear thermometer, which measures a physical parameter (temperature) and does not involve human readers interpreting images or data to make a diagnosis that would be assisted by AI. The device operates in a standalone manner.
6. Standalone Performance:
Yes, a standalone performance study was done. The "Clinical Accuracy Validation Test" performed according to ASTM E1965-98 directly evaluated the iHealth PT5 Infrared Ear Thermometer's performance in measuring body temperature in a clinical setting without human interpretation or intervention in the temperature measurement itself. The non-clinical tests also evaluated the device's technical standalone performance.
7. Type of Ground Truth Used:
Based on the nature of a clinical accuracy validation test for thermometers, the ground truth would most likely be established by a reference standard temperature measurement (e.g., core body temperature measurements from oral or rectal thermometers) taken by trained medical personnel. This is implied by the reference to ASTM E1965-98, which outlines methods for clinical performance evaluation of intermittent thermometers.
8. Sample Size for the Training Set:
The document does not mention a training set in the context of this device. Thermometers typically rely on established physical principles and calibration, not machine learning algorithms that require a "training set" in the conventional sense. The "correction algorithm to compensate the influence of ambient temperature using a heated tip" mentioned in the device description refers to a predefined algorithm, not one trained on a dataset.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set for a machine learning algorithm, this question is not applicable based on the provided text.
§ 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.