(176 days)
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
The Radiant Innovation Inc., Infrared Ear Thermometer, Models THP series are electronic thermometers that use an infrared detector (thermopile detector) to detect body temperature using infrared radiation from the auditory canal. Its operation is based on measuring the natural infrared thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is amplified by hardware and processed by the microprocessor. The temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.
Here's a breakdown of the acceptance criteria and study information for the Radiant Innovation Inc. Infrared Ear Thermometer THP Series, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | 35.5-42°C (95.9-107.6°F) +/-0.2°C (0.4°F), | |
| other +/-0.3°C (0.5°F) (from predicate device) | Not explicitly stated for THP series, but "repeatability of THP series are less than 0.3degC" (meets EN12470-5 and ASTM 1965-98) | |
| Repeatability | Meets EN12470-5 and ASTM 1965-98 | Less than 0.3°C |
| Applicable Standards Compliance | ASTM E1965-98, EN12470-5:2003, | |
| EN 60601-1 (IEC 60601-1), EN 60601-1-2 (IEC 60601-1-2) | Device found to be compliant with these standards through non-clinical tests |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "According the clinical report, the repeatability of THP series are less than 0.3degC. The result meets the criteria of EN12470-5 and ASTM 1965-98, so the THP series passes this clinical study."
- Sample Size: The sample size for the clinical study directly assessing repeatability is not specified in this document.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only refers to a "clinical report."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study was not conducted or mentioned for this device. The study focused on the device's technical repeatability and compliance with standards.
- Effect size of human reader improvement: Not applicable, as no MRMC study was performed.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes, in the sense that the clinical study evaluated the device's inherent repeatability (an algorithm-driven function for temperature detection and processing). The "repeatability of THP series are less than 0.3degC" refers to the device's performance directly.
- Note: This is a physical device, and "standalone performance" refers to the device's ability to measure temperature accurately and repeatably, not an AI algorithm generating readings for human review.
7. Type of Ground Truth Used
The ground truth for the clinical study on repeatability was established by the criteria defined in the standards EN12470-5 and ASTM 1965-98. These standards likely specify reference temperature sources and methodologies for assessing thermometer accuracy and precision.
8. Sample Size for the Training Set
- Sample Size: This information is not provided in the document. As this is not an AI/ML device in the modern sense of requiring extensive training data, the concept of a "training set" as commonly understood for AI models is not directly applicable here. The device's calibration and design would have been based on established thermometry principles.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: This information is not provided and is likely not applicable in the way it would be for a typical AI/ML system. The "ground truth" for the device's design and calibration would come from fundamental physics, engineering principles, and metrology standards for temperature measurement.
§ 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.