(137 days)
Infrared Thermometer is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
The Non-contact Forehead Infrared Thermometer (Model FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) measures the body temperature based on the infrared energy emitted from the forehead. Users can get measurement results after properly scanning the forehead. The thermometer of a shell, an LCD, a measure button, a beeper, an infrared temperature sensor, and a Microprocessor.
The device is widely used for home healthcare, medical institutes and many other occasions.
The provided text describes the regulatory clearance of a Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) and details the testing done to prove its substantial equivalence to a predicate device. This is not an AI/ML device, and thus, many of the requested elements for AI/ML device studies (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable or not found in the provided document.
However, I can extract information related to the acceptance criteria and the study that proves the device meets (or is equivalent to) those criteria for a traditional medical device, specifically a thermometer.
Here's a breakdown of the requested information, adapted to the context of a thermometer and the provided document:
Acceptance Criteria and Device Performance for Non-contact Forehead Infrared Thermometer
1. Table of Acceptance Criteria and Reported Device Performance
For medical thermometers, the primary acceptance criteria revolve around measurement accuracy and clinical performance. The document refers to compliance with specific international standards.
| Acceptance Criterion (Standard/Requirement) | Reported Device Performance (Reference) |
|---|---|
| Measurement Accuracy | |
| ISO 80601-2-56 compliance | The "Measuring accuracy" of the subject device (89.6°F-109.2°F (32.0°C-42.9°C)/±0.4°F/±0.2°C) is stated to be similar to the predicate device and both meet the requirement of ISO 80601-2-56. The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56. Based on the results, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2023), which correlates to ISO 80601-2-56. |
| Clinical Performance | |
| ASTM E1965-98 (Reapproved 2016/2023) | Clinical tests were conducted per ASTM E1965-98 (Reapproved 2016). Based on the result, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2023). |
| Electrical Safety and EMC | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ISO 80601-2-56 is reported. |
| Biocompatibility | Patient contacting components were subjected to biocompatibility testing in compliance with ISO 10993-1 and FDA guidance. |
| Software Function (if applicable) | Software documentation was provided in accordance with the FDA June 14, 2023 document "Content of Premarket Submissions for Device Software Functions". The software verification and validation test met the requirements, and performance testing shows compliance with performance standards. |
| Overall Substantial Equivalence | The device's technological characteristics, features, specifications, materials, mode of operation, and intended use are substantially equivalent to the predicate device. Differences (measuring range, measurement distance, memory, operating condition) do not raise new issues of safety or effectiveness and meet safety/performance standards. The software verification and validation test met requirements, and performance testing showed compliance with standards. The overall conclusion is that the device is substantially equivalent to the legally marketed predicate device. This is the overarching acceptance criterion for 510(k) clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A minimum of 143 subjects were used for the clinical study. These subjects were divided into three age groups:
- Group A1: 0 up to 3 months (Infant group)
- Group A2: 3 months up to 1 year (Infant group)
- Group C: Older than 1 to 5 years old (Child group)
- Group B and C: Above 5 years old (Adult group) - Note: The document lists B Child group (Older than 1 to 5 years old) and C group older than 5 years old. This seems to be a minor typo in the extract formatting, grouping A and B as infant and child, and then C as older. The key is that multiple age groups were tested.
- Data Provenance: The document does not explicitly state the country of origin of the clinical data. It states the study was a "randomization, simple blind homologous control, pairing design of clinical investigation." It is a prospective clinical study as it involved conducting tests with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the context of a non-contact infrared thermometer's clinical accuracy study. For such a device, a "ground truth" is typically established by comparative measurements against a highly accurate reference thermometer (e.g., a rectal thermometer) as per the ASTM E1965 standard, rather than expert consensus on images or interpretations. The expertise required would be in the conduct of the clinical study itself, ensuring proper procedure and data collection.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessment by multiple readers, common in diagnostic imaging. For a thermometer, the "ground truth" is a measured temperature value, not a subjective interpretation requiring adjudication among experts. The study design mentions "simple blind homologous control, pairing design."
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
This information is not applicable. The device is a Non-contact Forehead Infrared Thermometer, not an AI/ML-powered diagnostic imaging device involving human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an AI algorithm. The device itself is the "standalone" product, measuring temperature. Its performance is evaluated directly through non-clinical and clinical testing, not as an algorithm interpreting data for a human.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established by comparative temperature measurements against a reference method (likely rectal or oral temperature, as per ASTM E1965-98 standards for clinical thermometers). The study assessed the device's accuracy in relation to these established body temperature measurements. It is explicitly stated that the study followed ASTM E1965-98, which is a standard for clinical accuracy of infrared thermometers.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The document describes a traditional medical device, not an AI/ML device that requires a "training set" in the machine learning sense. The device is hardware-based, relying on infrared physics, not trained on a dataset of images or other input data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, this is not an AI/ML device with a "training set."
§ 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.