(212 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 THxxN 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 measured temperature then appears on a LCD display. The total operation takes a few seconds.
The provided text is a Special 510(k) Summary for a medical device called the "RII Infrared Ear Thermometer, Model THXXN Series." It details modifications to an existing device and argues for its substantial equivalence to previously cleared devices.
However, the document does not contain the level of detail required for a comprehensive description of acceptance criteria and the study that proves the device meets those criteria, as requested in your prompt. Specifically, it lacks:
- A table of acceptance criteria and reported device performance: While it mentions compliance with standards like ASTM E1965-98, it doesn't present specific performance metrics (e.g., accuracy, precision) against defined acceptance thresholds.
- Sample size and data provenance for a test set: There's no mention of a dedicated test set, its size, or where the data came from.
- Number and qualifications of experts for ground truth: No information on expert involvement in establishing ground truth.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device is a thermometer, so this type of study is unlikely to be relevant.
- Standalone (algorithm only) performance: Not mentioned, although as a thermometer, its performance is inherently standalone.
- Type of ground truth used: Not explicitly stated, though for a thermometer, the "ground truth" would typically come from a reference standard thermometer.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
What the document does state regarding acceptance criteria and testing:
The primary "acceptance criteria" discussed in this document revolve around substantial equivalence to predicate devices and compliance with applicable voluntary standards.
Acceptance Criteria and Reported Device Performance (as inferred):
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Intended Use | Same intended use as predicate devices. | "The RII Infrared Ear Thermometer THxxN series, have the same intended use and similar characteristics as the cleared device TH1 and TH8 series." (Intended use: detect body temperature from auditory canal in neonatal, pediatric, and adult populations in home setting). |
| Safety & Effectiveness | Do not raise any new questions of safety or effectiveness. | "bench testing contained in this submission supplied demonstrate that the modification of THxxN do not raise any new questions of safety or effectiveness." |
| Voluntary Standards | Compliance with: |
- ASTM E1965-98
- IEC 60601-1
- EN 60601-1-2 | "Compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC 60601 -1 and EN 60601-1-2 requirements." (Implies successful compliance, but no specific performance data presented). |
| Characteristics | Similar characteristics to predicate devices. | "The RII Infrared Ear Thermometer THxxN series, have the same intended use and similar characteristics as the cleared device TH1 and TH8 series." |
Regarding the "Study that Proves the Device Meets the Acceptance Criteria":
The document refers to "bench testing contained in this submission" as the study that demonstrates the device meets the safety and effectiveness criteria and supports the claim of substantial equivalence. However, no details of this bench testing are provided within the summary itself. We only know it was conducted and deemed sufficient by the submitter.
In summary, the provided text is a regulatory submission summary focused on demonstrating substantial equivalence, not a detailed technical report of a clinical or analytical study. It lacks the specific data points, methodologies, and participant details requested in your prompt.
§ 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.