(155 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 Thermometers are 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.
The Berrcom Ear Thermometer (models ET005, ET008, ET009) underwent a clinical accuracy validation to demonstrate its performance. The study followed ISO 80601-2-56:2017+AMD2018.
1. Acceptance Criteria and Reported Device Performance:
The document explicitly states that 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." However, the specific numerical acceptance criteria (e.g., maximum allowable bias or repeatability) are not provided in the submitted text. Therefore, the table below reflects what is stated in the document regarding meeting the criteria, but the exact values for the criteria cannot be extracted.
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance |
|---|---|---|
| Clinical Bias | (Not explicitly stated, but met) | Met acceptance criteria |
| Clinical Repeatability | (Not explicitly stated, but met) | Met acceptance criteria |
The document also provides measurement accuracy specifications which act as performance criteria:
| Temperature Range | Performance Criteria |
|---|---|
| Ear & Forehead: 32.0°C ~ 34.9°C (89.6°F ~ 94.8°F) | ± 0.3°C (± 0.5°F) |
| Ear & Forehead: 35.0°C ~ 42.0°C (95°F ~ 107.6°F) | ± 0.2°C (± 0.4°F) |
| Ear & Forehead: 42.1°C ~ 43.0°C (107.8°F ~ 109.4°F) | ± 0.3°C (± 0.5°F) |
| The document does not explicitly state that these criteria were tested during the clinical accuracy validation for individual subjects. Instead, it states the overall clinical bias and clinical repeatability met the acceptance criteria. |
2. Sample Size and Data Provenance:
- Sample Size: 150 subjects. This included:
- 50 infants (newborn to one year)
- 50 children (greater than one to five years)
- 50 adults (greater than five years old)
- Data Provenance: The document does not specify the country of origin of the data. It mentions "clinical investigation," which implies a prospective study.
3. Number of Experts and Qualifications:
The document does not provide information regarding the involvement of experts to establish ground truth, nor their qualifications.
4. Adjudication Method:
The document does not provide information regarding any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This study focuses on the accuracy of a single device against a ground truth, not on the improvement of human readers with AI assistance.
6. Standalone Performance:
Yes, a standalone performance study was done. The "Clinical accuracy validation" described is a test of the device's accuracy in measuring body temperature.
7. Type of Ground Truth Used:
The document refers to "clinical validation results demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol." While it implies a comparison to a referent temperature measurement standard (which would constitute the ground truth), the specific method for establishing this ground truth (e.g., rectal thermometer, oral thermometer, etc.) is not explicitly stated. However, given the context of clinical thermometry standards, it is highly likely a validated reference thermometer was used.
8. Sample Size for Training Set:
The document does not provide information about a training set since this is a medical device validation (Ear Thermometer), not an AI/machine learning model that typically has a training set.
9. How Ground Truth for Training Set was Established:
Not applicable, as no training set is 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.