(129 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, Model TH709L(E) is electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural 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 fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.
Here's an analysis of the acceptance criteria and supporting study for the Radiant Innovation Inc. Infrared Ear Thermometer TH709L(E), based on the provided document:
This document is a 510(k) summary for a Special 510(k) submission, meaning the device TH709L(E) is being asserted as substantially equivalent to a previously cleared predicate device (TH8 series) due to minor modifications. The focus of such submissions is typically demonstrating that the modifications do not raise new questions of safety or effectiveness, often through compliance with recognized standards and comparison to the predicate. Therefore, the "study" described is primarily about demonstrating compliance with accuracy standards rather than a comparative effectiveness study or a complex standalone algorithm validation.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ASTM E1965-98 and EN12470-5:2003, as implied by compliance) | Reported Device Performance (TH709L(E)) |
|---|---|
| Accuracy: ±0.2°C (±0.4°F) for 35.5°C to 42°C (95.9°F to 107.6°F) | ±0.2°C (0.4°F) for 35.5 |
| Accuracy: ±0.3°C (±0.5°F) for other temperature ranges | ±0.3°C (0.5°F) for other temperature ranges |
Note: The document explicitly states "Compliance to applicable voluntary standards includes ASTM E1965-98 and EN12470-5;2003". These standards define the accuracy requirements for clinical infrared thermometers. The reported performance in the comparison table mirrors these standard accuracy criteria, implying the device met these thresholds.
2. Sample size used for the test set and the data provenance
The document does not explicitly state a specific "test set" sample size or data provenance in terms of human subjects for a clinical study. The evaluation appears to be based on bench testing ("bench testing contained in this submission supplied demonstrate that the modification of TH709L(E) do not raise any new questions of safety or effectiveness.") and compliance with voluntary standards (ASTM E1965-98 and EN12470-5;2003). These standards typically involve specified test procedures and equipment to verify accuracy under controlled conditions, rather than a clinical trial with a specific number of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation focuses on compliance with technical standards through bench testing, not on interpreting medical images or data that would require expert adjudication. The "ground truth" for thermometer accuracy is established by highly accurate reference thermometers and controlled temperature environments as part of the standard testing protocols specified in ASTM E1965-98 and EN12470-5:2003.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3.
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
This information is not applicable. The device is an infrared ear thermometer, not an AI-powered diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an "algorithm only" performance as would be relevant for an AI device. The device performance itself (measuring temperature) is essentially a standalone function, and its accuracy is validated against established standards.
7. The type of ground truth used
The ground truth used for establishing the device's accuracy is derived from measurements taken by highly accurate reference instruments under controlled environmental conditions, as dictated by the specified voluntary standards (ASTM E1965-98 and EN12470-5:2003).
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.