(119 days)
The digital thermometer is intended to measure body temperature either orally or axillary (under the arm).
Digital Thermometer, HMCDT-002/Kinetik Branded DT1 Series
This FDA 510(k) clearance letter for a Digital Thermometer (K092557) does not contain the specific information required to complete your request.
The provided document is primarily an administrative letter granting clearance based on substantial equivalence to a predicate device. It confirms that the device can be legally marketed but does not detail the technical study results, acceptance criteria, or performance data you are asking for.
To answer your questions thoroughly, you would typically need access to the actual 510(k) summary or the full submission, which would include sections on performance testing, clinical performance (if applicable), and statistical analyses.
Therefore, under the constraints of the provided text:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The letter does not describe any specific acceptance criteria or performance metrics for the thermometer.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text.
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 available in the provided text. As this is a digital thermometer, the ground truth would likely be a reference thermometer, not expert-derived interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text. (Not applicable for a thermometer performance study).
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
- Not applicable in the provided text. This is a digital thermometer, not an AI-assisted diagnostic tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the provided text. The device itself is standalone in its function as a thermometer, but no "algorithm-only" performance as typically understood in AI/imaging is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available in the provided text. For a thermometer, the ground truth would typically be established using a calibrated reference thermometer, but this is not stated in the document.
8. The sample size for the training set
- Not available in the provided text. (Not typically relevant for a simple electronic thermometer, which is not usually 'trained' in the machine learning sense).
9. How the ground truth for the training set was established
- Not available in the provided text. (Not typically relevant for a simple electronic thermometer).
§ 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.