(240 days)
The Infrared Thermometer is intended for the measurement of human body temperatures. The forehead mode is indicated for people of all ages and the tympanic mode is indicated for people above three months old. The device can be used in the home setting and medical institutes.
FC-IR series infrared thermometers (Models: FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400) measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display.
The device is intended to be used in the home setting and medical institutes.
The product is mainly composed of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2 X 1.5 AAA batteries.
It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer.
In addition, when measuring the ear temperature, the ear cover must be used by all thermometer models except for the FC-IR200. FC-IR101 model incorporates Bluetooth technology to wirelessly transmit temperature reading to an APP.
The provided text describes the 510(k) premarket notification for the Shenzhen Finicare Co., Ltd. Infrared Thermometer (models FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400). The documentation focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Brav Electronic Technologies Co., Ltd., EFT-165 Infrared Thermometer /K171214), rather than presenting a standalone study proving the device meets specific acceptance criteria for a novel AI/ML-based diagnostic/screening tool.
Therefore, the information requested in the prompt (specifically regarding acceptance criteria, expert opinion, MRMC studies, standalone algorithm performance, and ground truth establishment for AI/ML) is not applicable to this traditional medical device clearance. The document outlines a performance study for a thermometer, not an AI/ML-driven diagnostic device.
However, I can extract the information relevant to the performance testing of the Infrared Thermometer as described:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily relies on adherence to recognized standards and comparative equivalence to a predicate device rather than presenting a specific table of device-specific acceptance criteria with corresponding performance numbers in the way one would for an AI/ML system.
The key "acceptance criteria" for this type of device are primarily compliance with accuracy standards and other regulatory requirements.
| Acceptance Criteria (Standard Compliance / Equivalence) | Reported Device Performance / Compliance |
|---|---|
| Accuracy (Body Mode) | ±0.2°C (0.4°F) - Same as predicate |
| Measurement Range | 32.0°C ~ 42.9°C (89.6°F ~ 109.2°F) - Same as predicate |
| Biocompatibility | Complies with ISO 10993-1 (Cytotoxicity, Skin Sensitization, Skin Irritation tests conducted) |
| Reprocessing (Cleaning and Disinfection) | Validation testing results are adequate and acceptable |
| Electrical Safety and EMC | Complies with ANSI/AAMI ES60601-1, IEC 60601-1-11, and IEC 60601-1-2 |
| Bench Testing (Performance Effectiveness) | Complies with ISO 80601-2-56 |
| Software Verification and Validation | Complies with FDA Guidance for "moderate level of concern" software |
| Risk Analysis | Conducted in accordance with ISO 14971: 2007 |
| Clinical Performance (Patient Temperature Measurement) | Conducted per ASTM E 1965-98 (2009) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Clinical Study: A minimum of 144 subjects across various age groups.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It implies a prospective clinical study given "clinical testing was conducted".
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable / Not explicitly stated. For a clinical thermometer, true core body temperature obtained via a reference method (e.g., rectal thermometer for infants, oral or axillary for adults where appropriate) serves as the ground truth. This is not a diagnostic device requiring expert consensus for image interpretation.
4. Adjudication Method for the Test Set:
- Not applicable. This device measures temperature, and its accuracy is validated against established temperature measurement methods, not through an adjudication process of human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is for evaluating human reader performance with and without AI assistance for diagnostic tasks. This is a thermometer, not an AI diagnostic tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable directly as an "algorithm." The core "algorithm" is the thermometer's internal processing for temperature conversion. The bench testing and clinical testing evaluate the device's standalone performance in measuring temperature.
7. The Type of Ground Truth Used:
- Clinical temperature measurements from subjects (presumably against a reference standard thermometer). The clinical study was conducted per ASTM E 1965-98 (2009) "Standard Specification for Infrared Thermometers For Intermittent Determination Of Patient Temperature," which outlines methods for establishing this ground truth.
8. The Sample Size for the Training Set:
- Not applicable. This is a hardware device with embedded software, not a machine learning model developed with a distinct "training set" in the AI sense.
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.