(146 days)
The devices models ET-100A、ET-100D、ET-100E、ET-100G、ET-1001、ET-100J, are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home . they are intended for use on people of all ages.
Infra-red ear thermometer model: ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
The provided text describes an FDA 510(k) clearance for an infra-red ear thermometer. It does not contain specific details about acceptance criteria, a comprehensive study report, or the methodology used to establish the device's performance against detailed acceptance criteria.
The document is a clearance letter, indicating that the device is substantially equivalent to legally marketed predicate devices. This implies that the manufacturer would have submitted data demonstrating this equivalence, but the details of that data and the specific acceptance criteria for performance are not explicitly in this letter.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
- Sample sized used for the test set and the data provenance: This information is not present in the provided document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the provided document.
- Adjudication method for the test set: This information is not present in the provided document.
- 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 is an infra-red ear thermometer, not an AI diagnostic device. Therefore, this type of study is irrelevant and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is an infra-red ear thermometer, so "algorithm only" performance in the context of human interpretation is not applicable. Its performance is its direct measurement.
- The type of ground truth used: While the device measures body temperature, the specific "ground truth" methodology (e.g., comparison to rectal temperature, oral temperature, or a traceable reference thermometer) for the equivalence study is not detailed in this document.
- The sample size for the training set: This information is not present in the provided document.
- How the ground truth for the training set was established: This information is not present in the provided document.
The document primarily focuses on the regulatory aspects of the device's clearance and its intended use as an infra-red ear thermometer for intermittent measurement of human body temperature.
To get the detailed information you are looking for (acceptance criteria, study design, sample sizes, ground truth establishment, etc.), you would typically need to review the full 510(k) submission, which is not provided here, or a detailed clinical study report published by the manufacturer.
§ 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.