(101 days)
The Infrared Ear Thermometer, Model DX-707 is intended for the intermittent measurement of human body temperature in home care environment. It is intended for use on people of all ages.
The DX-707 Infrared Ear Thermometer is a hand-held, non-sterile, reusable clinical thermometer using an infrared sensor that measures patient body temperature through the opening of the auditory canal. Its operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces. The DX-707 Infrared Ear Thermometer consists mainly of five parts with the associated circuit: (1) IR sensor, (2) Micom IC, (3) LCD module, (4) an ambient temperature sensor (thermistor), and (5) Keys, "I/O", "Measure". The DX-707 thermometer is powered by internal DC 3V battery, size CR2032 and it is supplied with probe cover.
The provided text describes the 510(k) submission for the "Instant Infrared Thermoscanner, DX-707" (also referred to as Infrared Ear Thermometer, Model DX-707).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission refers to compliance with established standards rather than specific numerical acceptance criteria for a novel device. The performance is reported in terms of equivalence and meeting these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Voluntary Standards: | |
| IEC60601-1 (General requirements for safety of medical electrical equipment) | Complies with IEC60601-1 requirements. |
| IEC60601-1-2 (Electromagnetic compatibility) | Complies with IEC60601-1-2 requirements. |
| ASTM Standard E1965-98 ("Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature") | Meets the requirements established in ASTM Standard E1965-98. |
| Clinical Equivalence: | |
| Equivalence to predicate devices in measuring ear temperature | Demonstrated that the DX-707 measured ear temperature equivalently to the predicate devices in all age groups. |
| Clinical repeatability | Clinical repeatability is statistically and clinically acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: "Approximately 39% of the patients participating in the study were considered febrile." This indicates a study population, but the absolute number of patients in the study (test set) is not explicitly stated.
- Data Provenance: The study involved different age groups: 0-3 years, 4-10 years, 11-65 years, and >65 years. No specific country of origin is mentioned for the clinical study data, but the submitter Jawon Medical Co., Ltd. is based in South Korea. The study is prospective as it's a "comparison study and clinical repeatability testing was performed".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
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 MRMC study was done. This device is an infrared ear thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting results. Therefore, questions regarding "human readers improve with AI vs without AI assistance" are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The entire submission pertains to the standalone performance of the DX-707 Infrared Ear Thermometer. The performance summary and clinical results section focus on the device's ability to measure temperature directly, complying with established standards and demonstrating equivalence to predicate devices.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the clinical comparison study was based on the measurements obtained from the "predicate devices". The text states: "...demonstrated that the DX-707 Infrared Ear Thermometer measured ear temperature equivalently to the predicate devices..." This implies comparison against the established accuracy of the legally marketed predicate devices. For clinical repeatability, the ground truth would be the repeated measurements themselves to assess consistency. The ultimate ground truth for temperature measurement, in general, is considered core body temperature, but here, the comparison is against another device.
8. The Sample Size for the Training Set
- Not applicable. This device is a medical device for temperature measurement, not a machine learning/AI algorithm that requires a separate "training set" in the context of supervised learning. Its design and validation rely on engineering principles, compliance with technical standards, and clinical comparison.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
§ 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.