(388 days)
The Infared Ear Thermometer is a non-sterile, reusable clinical thermometer intended for the determination of human temperature by radiation emitted via the ear (tympanic temperature).
The Infared Ear Thermometer is a clinical thermometer intended for the determination of human temperature by radiation emitted via the human ear (tympanic 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."
The K-Jump Health Co., Ltd. Infrared Ear Thermometer (Model KI-8120) is a clinical thermometer intended for the determination of human temperature by radiation emitted via the human ear (tympanic temperature).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document states that "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'."
However, the specific acceptance criteria (e.g., accuracy ranges at different temperature points) as defined by ASTM E1112, and the detailed reported performance of the K-Jump thermometer against these specific criteria, are not explicitly provided within the given FDA 510(k) summary.
To fulfill this table accurately, one would need access to the full ASTM E1112 standard and the detailed testing report submitted by K-Jump to the FDA. Without this, we can only state the general conformance.
| Acceptance Criteria (from ASTM E1112) | Reported Device Performance (K-Jump Infrared Ear Thermometer) |
|---|---|
| (Specific accuracy limits for various temperature ranges, resolution, response time, etc., as defined by ASTM E1112) | Conforms to ASTM E1112. (Specific numerical performance data, such as accuracy in °C or °F at different temperature points, is not provided in the submitted summary.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). This information would typically be found in the detailed testing report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts (e.g., medical professionals, technicians) used to establish the ground truth for any testing. For a thermometer, "ground truth" often refers to a highly accurate reference thermometer measurement.
4. Adjudication Method for the Test Set
The provided summary does not describe any adjudication method for establishing ground truth or resolving discrepancies in the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is typically relevant for diagnostic imaging devices where human readers interpret results. For a simple temperature measurement device like an ear thermometer, such a study would not be applicable or conducted. The device’s performance is determined by its accuracy against a traceable standard, not by human interpretation of its output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described, which involves conforming to ASTM E1112, represents a standalone performance evaluation. The device's accuracy and operating parameters are tested inherently without human intervention in the measurement process itself beyond typical user operation. The performance assessed is of the device's measurement algorithm and hardware.
7. The Type of Ground Truth Used
Based on the conformance to ASTM E1112, the ground truth for accuracy testing would have been established using traceable reference thermometers or temperature sources with significantly higher accuracy than the device under test. This is a standard metrological approach, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
For a traditional medical device like an infrared ear thermometer, there is generally no "training set" in the machine learning sense. The device's operating parameters (e.g., calibration curves, emissivity compensation) are determined during its design and manufacturing processes based on physical principles and material properties, not through a data-driven training algorithm in the way AI/ML models are trained. Therefore, "sample size for the training set" is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As explained above, there isn't a "training set" in the typical AI/ML sense for this type of device. The calibration and performance characteristics are established through engineering design, manufacturing processes, and quality control checks against known, traceable temperature standards, rather than through a data-driven ground truthing process for training.
§ 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.