(56 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 device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal.
The provided document is a 510(k) clearance letter for an infrared ear thermometer (Michealth ET 1100/ET 1200). It primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, or specific performance metrics.
The letter confirms the device's classification, indications for use, and regulatory compliance. It does not include information from the technical submission (which would detail the design, testing, and performance studies).
Therefore, based solely on the provided text, I cannot describe:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not applicable for a standalone thermometer.
- If a standalone performance (algorithm only without human-in-the-loop) was done: While the thermometer is a "standalone" device, the performance study details are not here.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable as it's not an AI/ML algorithm requiring a training set in the modern sense. Performance is typically evaluated against calibrated reference thermometers.
- How the ground truth for the training set was established: Not applicable.
To answer your questions thoroughly, you would need to consult the actual 510(k) submission (e.g., the "traditional 510(k)" or "special 510(k)" documentation) that contains the detailed performance studies, clinical equivalency data, and engineering specifications. This letter is merely the FDA's decision based on reviewing that submission.
§ 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.