(148 days)
The Ear Thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It is a non-contact method for forehead measurement, the recommended measurement distance is 0cm. The Ear Thermometer can be used by consumers in the household environment and by healthcare providers.
The Ear Thermometer, model of ET001 is a hand-held, battery powered infrared thermometer. It is intended to measure the temperature of human body from ear or forehead. The infrared sensor contained in the device can monitor the energy radiated from the human ear tympanum and forehead. The device can analyze and processes the signal transmitted by the infrared sensor, and finally displays it on the screen in digital form to achieve the measurement of human body temperature. People of all ages in household environment and doctors in clinic as reference are suitable for using the device.
It has the following features:
- Forehead and ear temperature measurement.
- Fahrenheit and Celsius temperature unit setting.
- Display resolution is 0.1°C (0.1°F);
- Memorize the latest 10 measurement data;
- Three color backlight display (red, orange, green)
- Low battery indication.
- Prompt for Measurement completion.
- Buzzer feature setting (mute or unmute)
- Turn off automatically after 75 seconds of inactivity.
The provided text describes the clinical accuracy validation for the Berrcom Ear Thermometer, Model ET001. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the clinical accuracy validation was conducted according to ISO 80601-2-56:2017+AMD2018. This standard defines the performance requirements for clinical thermometers, including accuracy. While the specific numerical acceptance criteria (e.g., maximum allowable bias, standard deviation of clinical repeatability) are not explicitly listed in the table provided in the input, the text clearly states:
"The clinical validation results demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol."
Therefore, the reported device performance is that it meets the acceptance criteria for clinical bias and clinical repeatability as defined by ISO 80601-2-56:2017+AMD2018.
| Metric | Acceptance Criteria (from ISO 80601-2-56:2017+AMD2018) | Reported Device Performance |
|---|---|---|
| Clinical Bias | (Not explicitly listed in the document) | Met the acceptance criteria |
| Clinical Repeatability | (Not explicitly listed in the document) | Met the acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 150 subjects
- 50 infants (newborn to one year)
- 50 children (greater than one to five years)
- 50 adults (greater than five years old)
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical study" and "clinical investigation," implying prospective data collection specifically for this validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text only mentions "clinical accuracy validation was conducted in according to ISO 80601-2-56:2017+AMD2018" and doesn't detail the role or number of experts for ground truth establishment. Clinical thermometers typically use a reference thermometry method (e.g., rectal or oral core temperature measurement) as ground truth, rather than expert consensus on images.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically relevant for studies involving human interpretation (e.g., imaging studies) where disagreements among readers need to be resolved. For clinical thermometer accuracy, the ground truth is established by a reference thermometer, not by interpretation requiring adjudication.
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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers (e.g., radiologists) use AI to improve their performance. The device here is a standalone thermometer, not an AI diagnostic assistant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "Clinical Accuracy Validation" described for the Ear Thermometer, Model ET001, demonstrates the device's accuracy in measuring body temperature directly, without human interpretation for the measurement itself. The device is a direct measurement tool, not an algorithm assisting human interpretation.
7. The Type of Ground Truth Used
The ground truth used for clinical accuracy validation of a clinical thermometer is typically a reference temperature measurement obtained through a highly accurate and validated method (e.g., rectal, oral, or arterial core temperature) according to the standards like ISO 80601-2-56. The document mentions "represented by clinical bias and clinical repeatability," which are calculated by comparing the device's readings to such a reference.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The Ear Thermometer is a hardware device based on infrared radiation detection and signal processing, not a machine learning or AI model that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As stated above, the device does not use a "training set" in the context of machine learning. Its performance relies on the design, calibration, and physical principles of thermometry.
§ 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.