(153 days)
Infrared Ear Thermometers, models ET-101D and ET-101H are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.It's intended for use on people of all ages.
The Infrared Ear Thermometers, models ET-101D and ET-101H are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. The thermometer's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. Both thermometer models include probes, which are used to measure ear canal temperature, plastic enclosures enclosing the display window as well as buttons and a battery cover. The disposable probe cover of ET-101H is optional when measuring temperature while ET-101D does not utilize a disposable probe cover. The Infrared Ear Thermometers measure temperature by reading infrared radiation emitting from the eardrum tissue. The small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues give off heat. The thermometer converts the heat into a temperature value using software.
Here's a breakdown of the acceptance criteria and study information for the Infrared Ear Thermometer (models ET-101D and ET-101H) based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by the precision (laboratory accuracy) and clinical accuracy, which align with the ASTM E1965-98 standard.
| Acceptance Criteria (Standard / Predicate) | Infrared Ear Thermometer ET-101D Performance | Infrared Ear Thermometer ET-101H Performance |
|---|---|---|
| Precision (Laboratory Accuracy) | ||
| ASTM E1965-98 (Reapproved 2009) | ±0.2°C (0.4°F) during 35.0°C | |
| ±0.3°C (0.5°F) for other measuring and operating temperature range. | Ear mode: ±0.2°C (0.4°F) during 35.5°C | |
| ±0.3°C (0.5°F) for other measuring and operating temperature range. | ||
| Object mode: ±4% or ±2°C (4°F) whichever is greater. | ||
| Room temperature: ±2°C (±4°F). | ||
| Clinical Accuracy | ||
| Predicate (ET-101A): | Clinical bias: 0.07°C (0.1°F) | Clinical bias: 0.08°C (0.14°F) |
| Clinical repeatability: 0.12 (0.2°F) | Clinical repeatability: 0.11 (0.2°F) | Clinical repeatability: 0.13 (0.23°F) |
| Limits of agreement: 0.8°C (1.4°F) | Limits of agreement: 0.76°C (1.4°F) | Limits of agreement: 0.76°C (1.31°F) |
| Other Requirements | Compliance Status | |
| Electrical Safety (AAMI/ANSI ES60601-1) | Complied | Complied |
| Performance (ISO 80601-2-56) | Complied | Complied |
| EMC (IEC 60601-1-2) | Complied | Complied |
| Biocompatibility (ISO 10993-5, ISO10993-10) | Complied | Complied |
| Home-used medical equipment (IEC 60601-1-11) | Complied | Complied |
| Software Validation | Complied | Complied |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Clinical evaluation of Infrared Ear Thermometers was conducted by Sejoy Electronics & Instruments Co., Ltd in compliance with ISO 80601-2-56 and ASTME1965." However, specific sample sizes for the clinical test set are not provided in this document. The geographic provenance of the data (country of origin) is also not explicitly stated, but given the manufacturer is Sejoy Electronics & Instruments Co., Ltd. from China, it is highly probable the study was conducted there. The document does not specify if the study was retrospective or prospective, but clinical evaluations for device approvals are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical evaluation. For temperature measurement devices, the ground truth is typically assessed against a highly accurate reference thermometer (e.g., rectal thermometer in a controlled setting) rather than subjective expert opinion.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
The document does not specify any adjudication method for the clinical test set.
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
No MRMC comparative effectiveness study was mentioned or conducted. This device is a diagnostic tool (thermometer) and does not involve human readers interpreting images or data where AI assistance would be relevant in that context. The "readers" are the users of the thermometer, and the output is a direct temperature reading.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is an inherently standalone device in terms of its core function: the device measures temperature and provides a reading. The clinical accuracy and precision tests are essentially standalone performance evaluations in a clinical setting. There is no "human-in-the-loop" performance in the sense of a human interpreting the device's output and making a further diagnosis/decision that needs to be assessed for improvement with AI. The user reads the temperature; the device algorithm calculates it.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For clinical accuracy, the ground truth for temperature measurement devices is typically established by simultaneous measurements using a highly accurate and calibrated reference thermometer (often a rectal thermometer in a controlled environment) to which the investigational device's readings are compared. The document mentions compliance with ISO 80601-2-56 and ASTM E1965, which both define rigorous methods for establishing clinical accuracy against reference standards. While not explicitly stated as "rectal thermometer readings," this is the industry standard for such evaluations.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. For a device like an infrared ear thermometer, there typically isn't a "training set" in the machine learning sense. The device's algorithm for converting infrared radiation to temperature is based on established physical principles and calibrated during manufacturing, rather than learned from a large dataset. The "training" for such a device would be more analogous to calibration and validation against physical standards.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the machine learning context is not applicable here, the concept of establishing ground truth for it is also not relevant. The device's underlying physics and algorithms are validated through bench testing and calibration against known temperature standards in a laboratory setting, and then confirmed for clinical accuracy against reference thermometers in human subjects.
§ 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.