(135 days)
The E-Care Infrared Ear Thermometer, models: LCT-300 and LCT-600, is an electronic clinical thermometer using an infrared sensor to detect body temperature from auditory canal for people of all ages in the home.
The E-Care Infrared Ear Thermometer, models LCT-300 and LCT-600 is a hand-held, battery-powered electronic thermometer which uses an infrared sensor (thermopile) to detect body temperature from auditory canal. Its operation is based on measuring infrared radiation from the tympanic membrane and the surrounding tissue. The signal of sensor is calculated and display by an ASIC controlled circuit. This device consists of a thermopile for the measuring sensor, an ASIC controlled circuit for calculating the electrical signal and an LCD to display the measured temperature.
By inserting the probe of this infrared ear thermometer into the outer canal, press the measurement button to start measurement. The electronic circuits amplify and calculate the signal of sensor, then display the temperature on LCD display. The total operation takes a few seconds.
The provided document describes the 510(k) summary for the E-Care Infrared Ear Thermometer (models LCT-300 and LCT-600) and its substantial equivalence to a predicate device.
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 document primarily focuses on demonstrating substantial equivalence to the predicate device Braun Thermoscan Infrared Ear Thermometer model: IRT3520 (K983295), rather than setting explicit new acceptance criteria that the device must meet independently. However, the comparison table implicitly uses the predicate device's performance as the benchmark for acceptance.
| Feature / Acceptance Criteria (Implied by Predicate) | Predicate Device (IRT3520) Performance | Subject Device (LCT-300 & LCT-600) Performance |
|---|---|---|
| Displayed Temperature Range | 34 | 0 |
| Operating Ambient Temperature Range | 10-40°C (50-104°F) | 10-40°C (50-104°F) |
| Display Resolution | 0.1°C or °F | 0.1°C or °F |
| Sensor Type | Thermopile | Thermopile |
| Accuracy | ±0.2°C | ±0.2°C (0.4°F): 36 |
| ±0.3°C (0.5°F): 34 | ||
| Memory | 8 | 10 |
| Battery | 2 X CR2032 | 1 X CR2032 |
| Probe Cover | With | LCT-300: Without |
| LCT-600: With |
Note on Accuracy: The accuracy specification for the subject devices is more detailed than the predicate, showing a slightly looser tolerance in the extreme ranges (±0.3°C vs ±0.2°C for the predicate). However, it matches in the core temperature range. The submission argues this difference does not affect safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "A clinical test report was conducted accord ASTM E1965." However, it does not specify the sample size used for this clinical test.
Regarding data provenance: The document does not explicitly state the country of origin. The submitter is E-Care Technology Co.,Ltd. based in Taiwan. It's safe to assume the testing was conducted in a location accessible to them, but this is not explicitly stated. The study is described as a "clinical test report," which implies a prospective study design to gather data on the device's accuracy.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical test.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method used for the clinical test data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The study described is a comparison of the subject device against a predicate device, focusing on accuracy, not the improvement of human readers with AI assistance. This device is a thermometer, not an AI-assisted diagnostic tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Yes, indirectly. The clinical test compares the E-Care Infrared Ear Thermometer (the "algorithm only," meaning the device's inherent measurement capability) against the predicate device. Since it's a standalone thermometer, its performance is its standalone performance without a human-in-the-loop directly interpreting the output beyond reading the temperature.
7. The Type of Ground Truth Used:
The ground truth used for these clinical tests would typically be a rectal thermometer or other highly accurate core body temperature measurement device as defined by the ASTM E1965 standard for infrared thermometers. The document does not explicitly state the specific ground truth method, but "clinical test report was conducted accord ASTM E1965" implies adherence to the methodology outlined in that standard for determining accuracy.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. Infrared ear thermometers (like the E-Care devices) are not typically "trained" in the machine learning sense. Their accuracy is based on their physical design, infrared sensor, and calibration, not on a training data set for an algorithm.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no "training set" in the context of this device's operation. Calibration would be performed against known temperature standards.
§ 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.