(70 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 for intermittent monitoring of human body temperature in the home setting.
The Radiant Innovation Inc., Infrared Ear Thermometer, Models THK09, IRT 3020 are electronic thermometers that use an infrared detector (thermopile detector) to detect body temperature using infrared radiantion 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 the study details for the Radiant Innovation Infrared Ear Thermometer (Models THK09, IRT 3020) based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinically acceptable value of +/- 0.2 deg C for bias and repeatability. | The summary results for bias, SD (Standard Deviation) and Repeatability using the Omron MC 341 and the Braun IRT 3020 Ear thermometers as reference devices showed that the bias and repeatability was within the clinically relevant acceptance criteria of +/-0.2 deg C. The standard deviations were within 0.5 deg C. |
Study Details
The provided document describes a clinical evaluation to ascertain the accuracy of the THK09 Infrared Ear thermometer.
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size (number of participants or measurements) used for the test set.
- The data provenance is not specified (e.g., country of origin). The study is described as a "clinical evaluation," implying it was prospective, but this is not explicitly stated.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The study compares the device to "legally marketed thermometers" rather than expert consensus on thermometry.
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Adjudication method for the test set:
- The document does not describe any adjudication method. The comparison appears to be direct against established reference thermometers.
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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:
- No, this was not an MRMC comparative effectiveness study. This device is a medical thermometer, and the study focuses on its accuracy against reference thermometers, not on improving human reader performance with AI. The device itself is an IR thermometer, not an AI diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The clinical evaluation assesses the performance of the THK09 Infrared Ear thermometer as a standalone device. Its measurement output is directly compared to reference devices rather than being an input to a human interpretive process.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" was established by two legally marketed reference thermometers in the US:
- The study was conducted in accordance with ASTM E1965:2003, which defines standards for clinical accuracy of IR thermometers.
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The sample size for the training set:
- This device is an infrared ear thermometer, which is a hardware device with embedded software for processing, not a machine learning or AI algorithm that typically requires a distinct "training set" in the computational sense. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here.
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How the ground truth for the training set was established:
- As explained above, the concept of a training set for an AI/ML algorithm does not apply to this device. Therefore, no ground truth was established for a training set.
§ 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.