(23 days)
The Talking Digital Thermometer is a non-sterile, reusable clinical thermometer intended for the determination of oral, rectal, and axillary body temperature determination humans
The Talking Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal, and axillary body temperature determination in humans. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature."
The provided document for the K-Jump Health Co., Ltd.'s Talking Digital Thermometer (K984553) indicates that the device's conformance to a standard specification acts as its acceptance criteria and basis for substantial equivalence.
Here's a breakdown of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance/Compliance |
|---|---|
| Conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature." | "In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature." (Page 0) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for any test set or the data provenance. It only mentions conformance to a standard.
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)
The document does not provide information about experts used to establish ground truth. Conformance to the ASTM standard implies testing conducted according to that standard's methodologies, which would specify measurement devices and procedures, not necessarily human expert consensus for "ground truth" in the way it might be for a diagnostic image.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method.
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
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This device is a digital thermometer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of a clinical thermometer. Its performance is inherently "standalone" in that it directly measures and displays temperature. The document states its conformance to ASTM E1112, which implies testing of its accuracy and performance as a standalone device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a digital thermometer conforming to ASTM E1112, the "ground truth" would be established by reference temperature standards and calibrated measurement equipment, not expert consensus, pathology, or outcomes data in the typical sense. The standard itself outlines the methods for accuracy verification.
8. The sample size for the training set
The document does not mention a training set. This device is a conventional medical device, not a machine learning or AI-based system that would typically have a "training set."
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or implied for this type of 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.