(88 days)
The Infrared Body Thermometer, Model: HTD8216C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead or auditory canal in people of all ages for home setting use.
Infrared Body Thermometer, model: HTD8216C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the central forehead or auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the central forehead or tympanic membrane.
The forehead mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the central forehead skin. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor.
The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal.
To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Infrared Body Thermometer, Model: HTD8216C
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Standard Compliance | Meet ASTM E1965-98 and ISO 80601-2-56 | Meets ASTM E1965-98 and ISO 80601-2-56 |
| Measuring Range | Predicate: 34 | Proposed Device: 34.0°C |
| Measuring Accuracy | ±0.2°C (0.4°F) within 35 | ±0.2°C (0.4°F) within 35 |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-11 | Complied (Demonstrated by testing) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Complied (Demonstrated by testing) |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10 | Complied |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document states that the clinical investigation report and data analysis followed the requirements of ASTM E 1965-98 and ISO 80601-2-56. These standards typically specify patient cohorts and measurements for clinical accuracy testing. However, the exact sample size for the test set is not explicitly stated in the provided text. It only mentions "three group's temperature readings difference".
- Data Provenance: Not explicitly stated. The document is from a Chinese company (HeTaiDa Technology Co., Ltd. in Guangdong, China) and was submitted to the FDA. It does not clarify if the clinical study was conducted in China, the US, or elsewhere, nor whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The study compares the device's readings to a "digital thermometer" (referred to as the "ground truth" or reference, typically a rectal or oral thermometer), but does not mention experts establishing a ground truth for individual cases. For clinical thermometer accuracy, the ground truth is usually established by a validated reference thermometer.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None explicitly mentioned. For clinical accuracy studies of thermometers, an adjudication method for human interpretation is not typically required, as the ground truth is a direct temperature measurement from a reference device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an infrared body thermometer, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is essentially a standalone device performance study. The device itself measures and displays temperature. The clinical study evaluated the accuracy of the device's measurements relative to a reference (digital thermometer) without directly involving a human-in-the-loop for interpretation of the device's output.
7. The type of ground truth used:
- Clinical temperature measurements from a reference device. The "digital thermometer" serves as the ground truth for comparison. This implies a standard clinical measurement method that is widely accepted for accuracy.
8. The sample size for the training set:
- This information is not provided as there is no mention of a "training set" in the context of this device. Thermometers are typically calibrated during manufacturing and their accuracy is demonstrated through performance testing against established standards, rather than machine learning training.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned for this device.
§ 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.