(214 days)
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal or on the forehead in the neonatal, pediatric and adult population used at home.
The easytem duo Forehead/Ear Thermometer is a dual purpose hand held instrument that measures body temperature on the forehead or through the opening of the auditory canal. The forehead operation is based on measuring the temperature on the surface of the forehead while the ear operation measures the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
The provided text describes the "easytem duo, Dual Thermometer, Forehead/Ear, Model BT-021" and its substantial equivalence to predicate devices, but it does not contain the detailed study information requested. Specifically, it lacks information on acceptance criteria, a performance study, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance. The document is primarily a 510(k) summary and FDA clearance letter, focusing on regulatory equivalence rather than a detailed performance study report.
Therefore, many of your requested fields cannot be filled from the provided text.
Here's what can be extracted related to the device and its regulatory status:
Device: easytem duo, Dual Thermometer, Forehead/Ear, Model BT-021
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating "substantial equivalence" to predicate devices, implying that the performance of the easytem duo should be comparable to the predicates, particularly in terms of accuracy for temperature measurement.
- Reported Device Performance: Not explicitly stated with specific numerical performance metrics. The document mentions: "The easytem duo Forehead/Ear Thermometer has the same general design and performance characteristics as the predicate devices from Braun, and SAAT." It also states, "This submitter concludes that the easytem duo Thermometer is therefore substantially equivalent in the 'ear mode' as to the predicate devices 'Braun Thermoscan RT3520' and to the 'ThermoTek 718F' in the 'forehead mode'." This is a statement of perceived equivalence rather than a direct report of performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. No performance study with expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No performance study with a test set.
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:
- No. This device is a thermometer, not an AI-assisted diagnostic tool for human readers. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not provided. While the device itself is a standalone thermometer, the document does not detail a standalone performance study with specific metrics, but rather relies on substantial equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. No detailed performance study, and therefore no specific ground truth method, is described. For a thermometer, the "ground truth" would typically come from an accurate reference thermometer or controlled temperature environments, which are not mentioned.
8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning device that would typically have a "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This is not an AI/machine learning device.
§ 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.