(115 days)
K-jump Health Co, Ltd. Digital Forehead Thermometers, Model KD-2201 & KD-2210, are intended to measure the human body temperature using the forehead as measurement site. They can be used with adult or pediatric patients.
The Digital Forehead Thermometers, Model KD-2201 & KD-2210, consist of a probe with thermister sensor and stainless steel plate, a PC board with ASIC circuits, a LCD display, a plastic main body, an ON/OFF power key, a buzzer and two AAA type batteries for the determination of human body temperature.
The acceptance criteria and study proving device performance are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (KD-2201 & KD-2210) |
|---|---|
| Accuracy (Measuring accuracy) | ±0.1°C (35.0°C ~ 42.0°C) |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set in terms of the number of measurements or subjects. Rather, it refers to compliance with voluntary standards.
The provenance of data is not specified in terms of country of origin or whether it was retrospective or prospective, as clinical trials were deemed unnecessary.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The ground truth was established through compliance with recognized performance standards (ASTM E 1112-00 and EN 12470-3), not through expert consensus derived from a clinical test set.
4. Adjudication Method for the Test Set:
Not applicable, as there was no expert adjudication process for establishing ground truth in this non-clinical performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. The device is a standalone thermometer, and the evaluation focused on its intrinsic accuracy against standards rather than its performance with or without AI assistance for human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):
Yes, a standalone performance evaluation was conducted. The devices were tested for compliance with recognized performance standards (ASTM E 1112-00 and EN 12470-3). These standards typically involve testing the device's accuracy and other performance characteristics under controlled conditions, without human interpretation as part of the core performance metric.
7. Type of Ground Truth Used:
The ground truth was established by recognized performance standards for clinical electronic thermometers: ASTM E 1112-00 and EN 12470-3. These standards define the acceptable limits for accuracy and other performance parameters.
8. Sample Size for the Training Set:
Not applicable. The document describes a medical device (a thermometer), not an AI/machine learning algorithm, and therefore there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/machine learning algorithm.
§ 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.