(205 days)
A&D Medical UT-101 LifeSource Digital Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.
A&D Medical UT-101 LifeSource Digital Ear Thermometer
This is a clearance letter for a digital ear thermometer and lacks the detailed performance study information typically found in a 510(k) summary or premarket approval application. Therefore, most of the requested information cannot be extracted from this document.
Here's what can be provided based on the given text:
1. A table of acceptance criteria and the reported device performance
The provided document (a clearance letter) does not contain a table of acceptance criteria or specific reported device performance data beyond the device's intended use.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
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)
This information is not available in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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
Given that the device is a simple digital ear thermometer, it is highly unlikely that an MRMC study involving human readers and AI assistance would be relevant or performed. This information is not mentioned in the provided document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Given that the device is a simple digital ear thermometer, it is unlikely to involve complex algorithms that would require a "standalone" performance study in the context of AI or advanced diagnostic imaging. The document does not mention any such study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a thermometer, the "ground truth" for accuracy would typically involve comparison to a highly accurate reference thermometer (e.g., a calibrated laboratory thermometer) across a range of temperatures, rather than expert consensus, pathology, or outcomes data in the medical diagnostic sense. However, the specific type of ground truth used is not detailed in this document.
8. The sample size for the training set
This information is not available in the provided document.
9. How the ground truth for the training set was established
This information is not available in the provided document.
Summary of available information from the document:
- Device Name: A&D Medical UT-101 LifeSource Digital Ear Thermometer
- Intended Use: Intermittent measurement and monitoring of human body temperature by consumers in the home, for use on people of all ages.
- Regulatory Class: II
- Product Code: FLL
- Clearance Status: Substantially equivalent to pre-amendment devices, allowing market entry subject to general controls.
§ 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.