(41 days)
The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1 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 FR1DZ1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the forehead. Microlife FR1DZ1 specially enables you to take measurements and judge the readings according to vour local habits. It can measure for three types of readings comparable to readings measured at such three conventional measuring sites as rectal, oral, and axillary with an ordinary pen-type thermometer.
This Infrared Forehead Thermometer enables very safe and reliable measurements and with its technology the thermometer offers a very high clinical accuracy and has been designed to provide a maximum of userfriendliness.
The Microlife Non-Contact Infrared Forehead Thermometer consists mainly of seven parts:
- a) Thermopile Sensor
- b) ASIC
- c) E2PROM IC
- d) Lens
- e) LCD and Backlight
- f) 3 Keys (Offset 2 keys: optional), 1 Buzzer
- g) 2 batteries AAA (LR03)
This document describes the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1, and studies supporting its regulatory submission.
1. Table of Acceptance Criteria and Reported Device Performance
The submission references compliance with ASTM E1965, which sets standards for infrared thermometers. While the precise acceptance criteria and detailed device performance metrics from the study are not explicitly itemized in the provided text, the standard implies the following (common for clinical thermometers):
| Acceptance Criteria (Implied by ASTM E1965) | Reported Device Performance (from "8. Discussion of Clinical Tests Performed") |
|---|---|
| Clinical Accuracy | Clinical data was presented evaluating clinical bias, clinical uncertainty, and clinical repeatability. |
| Clinical Repeatability | Clinical data was presented evaluating clinical bias, clinical uncertainty, and clinical repeatability. |
| Clinical Bias | Clinical data was presented evaluating clinical bias, clinical uncertainty, and clinical repeatability. |
Note: The document states that "Clinical data was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per clinical validation for Microlife FR1DZ1," but it does not provide the specific numerical values or acceptance thresholds used within ASTM E1965 for the 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
The text states that "Controlled human clinical studies were conducted in accordance with ASTM E1965." However, the sample size used for the test set is not specified. The data provenance is also not specified (e.g., country of origin, retrospective or prospective), beyond being "controlled human clinical studies."
3. Number of Experts Used to Establish Ground Truth and Qualifications
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. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or implied in the provided text, as the device is a standalone thermometer, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance
A standalone performance study was done. The clinical studies evaluating "clinical bias, clinical uncertainty and clinical repeatability" directly assess the algorithm's (thermometer's) performance without human interpretation as part of the measurement process. The device's primary function is to provide a direct temperature reading.
7. Type of Ground Truth Used
The ground truth for the clinical studies would have been established by a reference method for temperature measurement (e.g., a highly accurate rectal thermometer or other standardized clinical thermometer). This is implied by the adherence to ASTM E1965, which outlines methods for clinical accuracy evaluation against a reference standard. The specific reference method is not explicitly stated in the provided text, but it would be a form of clinical measurement data.
8. Sample Size for the Training Set
This information is not applicable for this device as it is a physical thermometer with embedded algorithms for temperature conversion, not a machine learning model that undergoes a training phase with a distinct training set. The algorithms are based on established thermometry principles.
9. How Ground Truth for the Training Set Was Established
This information is not applicable for this device, as explained in 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.