(13 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 TH88 series are electronic thermometers 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 total operation takes a few seconds. The measured temperature then appears on a LCD display.
The provided text describes a Special 510(k) submission for the Radiant Innovation Inc. Infrared Ear Thermometer, Models TH88 series. This submission focuses on demonstrating substantial equivalence to a previously cleared device (Models TH8 series) based on minor modifications (outer appearance and probe cover installation instructions). As such, the submission primarily relies on compliance with voluntary standards rather than a detailed performance study with acceptance criteria and statistical analysis of device performance against a ground truth.
Therefore, many of the requested details about acceptance criteria and a comprehensive study showing the device meets them cannot be extracted directly from this document. The document states that the modifications "will not significantly change the safety and effectiveness" and that "bench testing contained in this submission supplied demonstrate that the modification of TH88 do not Thus, the RII Infrared Ear raise any new questions of safety or effectiveness."
However, I can extract information related to the standards the device complies with, which implicitly define performance expectations.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document explicitly states compliance with ASTM E1965 for clinical electronic thermometers. This standard defines performance requirements (e.g., accuracy, precision, stability).
- Reported Device Performance: The document does not provide specific performance metrics (e.g., mean bias, standard deviation of differences) for the TH88 series. It only states that the device complies with ASTM E1965, implying its performance meets the requirements of that standard.
Table of Acceptance Criteria (from ASTM E1965 compliance) and Reported Device Performance (implied):
| Acceptance Criteria (from ASTM E1965) | Reported Device Performance |
|---|---|
| Specific performance metrics as defined by ASTM E1965 (e.g., accuracy, precision, repeatability, stability under various conditions) | Device is compliant with ASTM E1965, implying it meets the performance requirements of this standard. Specific numerical performance data for the TH88 series is not provided in this document. |
| Safety requirements as per IEC 60601-1 and IEC 60601-1-2 | Device is compliant with IEC 60601-1 and IEC 60601-1-2, implying it meets the safety and EMC requirements. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document. The document refers to "bench testing," which typically occurs in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document does not describe a clinical study where ground truth would be established by experts. Performance is assessed against a standard (ASTM E1965), which would involve calibrating the device against known temperature references.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. No human adjudication described for performance testing of a thermometer.
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:
- Not applicable. This is a simple electronic thermometer, not an AI-powered diagnostic device requiring MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. While the thermometer operates "standalone" in function, the document does not describe a standalone algorithm performance study in the context of AI/software. Its performance is measured directly as a device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for evaluating thermometer accuracy generally involves known, precisely controlled temperature references (e.g., a calibrated blackbody radiator or temperature bath) as specified by standards like ASTM E1965. The document implies this by stating compliance with ASTM E1965.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model that would require a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/machine learning model that would require a "training set."
In summary, the document is a Special 510(k) for minor device modifications, and as such, it defers to compliance with established voluntary standards (primarily ASTM E1965) for demonstrating safety and effectiveness rather than presenting a novel, detailed performance study with clinical ground truth and expert adjudication.
§ 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.