(121 days)
The devices are intended to measure the human body temperature using the forehead as measurement site. It can be used with adult or pediatric patients.
The Digital Forehead Thermometer, Model KD -2200, consists 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 tip of probe is made with a thermister sensor and stainless steel plate which may sense the temperature changing. The electronic signal was transferred to ASIC circuit on PC board through sensor of probe. The LCD displays the predictive temperature or last temperature recorded and warning information during measurement.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Disclaimer: This document is a 510(k) summary from 2007 for a medical device. The level of detail provided in such summaries is often limited, focusing on demonstrating substantial equivalence to a predicate device rather than a comprehensive disclosure of all study specifics. Therefore, some information requested might not be explicitly available in the provided text.
Description of Acceptance Criteria and Proving Study
The K-jump Health Co., Ltd. Digital Forehead Thermometer, Model KD-2200, demonstrates compliance with acceptance criteria primarily through adherence to established international standards for electronic thermometers. The study mentioned focuses on demonstrating this compliance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Section | Requirement/Description | Reported Device Performance | Comments from Text |
|---|---|---|---|---|
| ASTM E1112-00 (Reapproved 2006) | N/A | "Electronic Thermometer for Intermittent Determination of Patient Temperature" | Complies with the standard. | This standard specifies accuracy, readability, response time, and other performance characteristics for electronic clinical thermometers. The document states the device complies. |
| EN 60601-1-2 (2001) | N/A | Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | Complies with the standard. | This standard covers electromagnetic compatibility, ensuring the device operates correctly in its intended electromagnetic environment. |
| EN 60601-1 (1997) | N/A | Medical electrical equipment - Part 1: General requirements for safety | Complies with the standard. | This standard outlines general safety requirements for medical electrical equipment. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the device "complies with" the ASTM E1112-00 standard, which implies a performance study was conducted according to that standard's testing requirements. The ASTM E1112 standard would define the required sample size and methodology for testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not provide any information regarding the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The provided text does not specify any adjudication method for the test set. Given the nature of a thermometer, ground truth is typically established through a calibrated reference standard, not expert consensus or adjudication.
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
No, an MRMC comparative effectiveness study was not done. This device is a thermometer, not an AI-powered diagnostic tool, so the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The provided text indicates that the device's performance was assessed in a standalone fashion conforming to the ASTM E1112-00 standard. A thermometer, by its nature, operates in a "standalone" mode, measuring temperature directly. The output (the temperature reading) is the direct result of the device's internal algorithms and sensors. There is no "human-in-the-loop" performance in the sense of interpreting an output that requires cognitive processing from a human.
7. The Type of Ground Truth Used
The ground truth used for assessing the performance of the thermometer would be calibrated reference temperatures. The ASTM E1112-00 standard dictates specific testing methodologies that involve comparing the device's readings to highly accurate and traceable reference thermometers or temperature sources. The text doesn't explicitly state "calibrated reference temperatures," but compliance with ASTM E1112-00 inherently implies this type of ground truth.
8. The Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or artificial intelligence models. This device is a traditional electronic thermometer, and therefore, there is no training set in the AI sense. Its "training" would be inherent in its design, calibration, and manufacturing processes.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this type of device in the context of AI/ML, this question is not applicable. The device's accuracy is established through design validation and verification against calibrated standards during its development and manufacturing, not through a "training set" with established ground truth.
§ 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.