(64 days)
The Non-contact Clinical Thermometer, Model THB0F is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
The RII Non-contact Clinical Thermometer, Model THBOF is electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the Forehead. Its operation is based on measuring the natural thermal radiation emanating from the temples to hairline upper eyebrows. The thermometer consists mainly of the following parts: an IR sensor with a built-in ambient temperature sensor, a thermo-mass, and the associated circuit. The forehead skin, which is thin and beneath, which is the temporal artery, with blood very near to the core temperature. The forehead skin must cover the whole FOV(Field of View) of the sensor. When measuring, radiation fluxes transfer from the skin to the IR detector. The ambient sensor is mounted in the IR sensor package, and near the IR detector element to monitor the ambient temperature. To measure core temperature, the probe of the thermometer are slide through the skin of the a patient's forehead. A activation button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appear on a LCD display. The total operation takes a few seconds.
The Radiant Innovation Inc. Non-contact Clinical Thermometer, Model THB0F, is an infrared thermometer intended for intermittent measurement of human body temperature in people of all ages.
Here's an analysis of its acceptance criteria and the study that proves its performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Forehead Mode) | Reported Device Performance (Forehead Mode) |
|---|---|---|
| Accuracy | ±0.4°F (0.2°C) within 96.8°F to 102°F (36°C to 39°C) | Clinical investigation report states that temperature readings difference between digital thermometer and the subject device (THB0F) are within acceptable range, demonstrating the device meets the ASTM E 1965-98 standard for accuracy. |
| ±0.5°F (0.3°C) for other ranges | ||
| Measuring Range | 93.2°F to 108°F (34°C to 42.2°C) | 93.2°F to 108°F (34°C to 42.2°C) |
| Display Resolution | Not explicitly stated as an acceptance criterion, but the predicate has 0.1°F (0.1°C) | 0.1°F (0.1°C) |
Additional Acceptance Criteria (General Safety and Standards Compliance):
- Compliance to applicable voluntary standard ASTM E1965-98: Met.
- Compliance to recognized consensus standards for safety of medical electrical equipment: Met (EN 60601-1 (IEC 60601-1) for safety and EN 60601-1-2 (IEC 60601-1-2) for electromagnetic compatibility).
- Compliance to FDA Guidance On The Content of Premarket Notification 510(k) Submissions for Clinical Electronic Thermometers: Met.
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "The clinical investigation report and data analysis is followed the requirements the ASTM E 1965-98." However, it does not explicitly specify the sample size used for the clinical test set or the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts used to establish the ground truth for the clinical test set, nor does it provide their qualifications. The clinical test compares the THB0F's readings against a "digital thermometer." It implies the "digital thermometer" serves as the reference or "ground truth" for the comparison.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the test set. The clinical test appears to be a direct comparison of temperature readings between the subject device and a digital thermometer.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. This device is a standalone thermometer, not an AI assistance tool for human readers.
6. Standalone (Algorithm Only) Performance:
Yes, the primary clinical test performed was a standalone performance study for the device. The study evaluated the accuracy of the THB0Fometer in measuring human body temperature independently. The document states: "The test report shows the three group's temperature readings difference between digital thermometer and the subject device, THB0F are within acceptable range."
7. Type of Ground Truth Used:
The ground truth used for the clinical test was based on measurements from a "digital thermometer." This implies a comparison against an established, accurate clinical thermometer.
8. Sample Size for the Training Set:
The document does not describe a training set for an algorithm, as this device is a hardware clinical thermometer dependent on an infrared sensor and associated circuitry, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set or an algorithm in the context of machine learning, the question of how its ground truth was established is not applicable. The device's performance is validated through physical and clinical testing against established standards and other measurement devices.
§ 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.