(219 days)
The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200) is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The device uses CapSense Technology to detect distance this technology is used to assist measurement. The concept of proximity sensor detects human electrical proximity level to transform to distance. The distance control feature is added to the user interface to identify the measurement distances are in the correct parameter. In other words, the device will enter into measurement mode after the correct measurement distance is detected. This device can take a measurement automatically when the device detects the distance is appropriate within 5 cm.
The provided text describes the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200), and its comparison to a predicate device (Microlife Non-Contact Infrared Forehead Thermometer FR1DZ1, K100953) for substantial equivalence in an FDA 510(k) submission.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200) intends to meet the accuracy requirements of the ISO 80601-2-56: 2017 standard (implicitly, as it's listed as a standard the device was tested against and clinical testing was done according to ASTM E1965-98, which typically defines accuracy limits for clinical thermometers).
The device's reported laboratory accuracy is as follows:
| Temperature Range (°C) | Accuracy (°C) | Temperature Range (°F) | Accuracy (°F) |
|---|---|---|---|
| 35.0 ~ 42.0 | ±0.2 | 95.0 ~ 107.6 | ±0.4 |
| 34.0 ~ 34.9 | ±0.3 | 93.2 ~ 94.8 | ±0.5 |
| 42.1 ~ 43.0 | ±0.3 | 107.8 ~ 109.4 | ±0.5 |
The document also mentions that "the test report demonstrated that the clinical data, represented by clinical bias met the acceptance criteria of the clinical study protocol." However, the specific numerical acceptance criteria for clinical bias are not explicitly stated in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 116 subjects.
- 38 infants (newborn to one year)
- 41 children (greater than one to five years)
- 37 adults (greater than five years old)
- Data Provenance: The document does not explicitly state the country of origin. It describes a "clinical study" which implies prospective data collection, but does not explicitly state "prospective."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study is described as a "randomization, simple blind homologous control, pairing design of clinical investigation," and it states that "clinical bias met the acceptance criteria," suggesting a comparison against a reference thermometer measurement taken by an expert, but the number and qualifications of such experts are not detailed.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. The study design mentions "simple blind homologous control" and "pairing design," but doesn't specify how ground truth discrepancies (if any) were resolved or if multiple readers were involved in establishing the ground truth measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided. The text describes a clinical study to assess the accuracy of the device itself, not a comparative effectiveness study involving human readers with and without AI assistance. The device is a thermometer, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The clinical testing described is primarily focused on the device's ability to measure temperature directly, without human interpretation of complex images or data where "human-in-the-loop" would typically apply. The "clinical bias met the acceptance criteria" refers to the instrument's performance.
7. Type of Ground Truth Used
The ground truth used was clinical data obtained from a "randomization, simple blind homologous control, pairing design of clinical investigation." In thermometer studies, this typically involves comparing the device's readings against a highly accurate reference thermometer (e.g., a rectal or oral mercury/electronic thermometer, or another gold standard for body temperature measurement) by an expert under controlled conditions. The term "clinical bias" supports this interpretation.
8. Sample Size for the Training Set
This information is not provided. The document makes no mention of a "training set," as the device is a medical measurement instrument. While it has algorithms (e.g., PH15.0 Algorithm for temperature calculation), these are typically developed through engineering and calibration, not through machine learning training sets in the same way an AI diagnostic algorithm would be.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as the concept of a "training set" with established ground truth in the context of machine learning does not directly apply to the development and validation of this type of electronic thermometer. The algorithms for temperature calculation would be based on physical principles, calibration, and engineering, rather than a data-driven training process with labeled ground truth data.
§ 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.