(92 days)
The Braun BFH175 Infrared Forehead Thermometer is a non-sterile, clinical thermometer intended for the intermittent determination of human body temperature in a touch mode using the center of the forehead as the measurement site on people of all ages.
The Braun BFH175 Infrared Forehead Thermometer is a hand-held, battery powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the user's forehead, to an oral equivalent temperature when placed in contact with the subject's forehead. It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
The Braun BFH175 Infrared Forehead Thermometer was evaluated through non-clinical and clinical testing.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Modification | Associated Risks | Performance Standard | Acceptance Criteria | Result |
|---|---|---|---|---|
| Updated industrial design with PCB layout change | Incorrect reading or minor electrical shock to user | EN 60601-1:2014 | Touch current: 100 µA NC; 500 µA | |
| Patient leakage current: 10 µA NC; 50 µA SFC (DC current) | ||||
| Patient leakage current w/ mains on the BF-type applied parts: Type BF: 5000 µA | Pass | |||
| Updated industrial design with PCB layout change | Incorrect reading | IEC 60601-1-2:2014 | Radiated RF EM fields: 10 V/m; 80 MHz – 2.7 GHz | |
| RF wireless communications equipment immunity: 9 - 28 V/m; 385 – 5785 MHz; 0.2 to 2.0 Watts at 1 m; Multiple services and modulations | ||||
| Rated power frequency magnetic fields: 30 A/m; 50 Hz or 60 Hz | Pass | |||
| Updated industrial design | Incorrect reading or minor electrical shock to user | IEC 60601-1-11:2015 | Ingress Protection: IP22 | Pass |
| Updated industrial design | Incorrect reading or minor electrical shock to user | ASTM E1965-98:2016 | Shock / Drop: Absolute value of the largest error out of five (5) measurements of a blackbody at 37 ± 0.5°C, in an ambient environment of 20 - 26°C and 40 - 70% relative humidity, taken after the device is subjected to a fall from a height of 1 meter, is less than or equal to ± 0.2°C | Pass |
| Removal of digital proximity sensor (Clinical Performance) | Incorrect reading | ISO 80601-2-56:2017 | Bias: Bias for the test device should be non-inferior to the bias of the predicate device when compared to the reference, and ≤ ±0.20°C | |
| Standard Deviation: Standard Deviation for test device should be equivalent to or less than the Standard Deviation of the predicate device | ||||
| Repeatability: Repeatability for test device should be ≤ ±0.3°C | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text for the clinical study. It is referred to as a "controlled human clinical study."
- Data Provenance: The nature of the clinical study (multi-center, randomized) suggests it was a prospective study. The country of origin of the data is not specified.
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.
4. Adjudication method for the test set
This information is not provided in the document.
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
An MRMC study was not conducted. This device is an infrared thermometer, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done as part of the clinical study, specifically for the device's accuracy (bias, standard deviation, repeatability) against a reference. The device being a thermometer, its primary function is standalone measurement.
7. The type of ground truth used
For the clinical performance, the ground truth was a reference measurement against which the device's bias, standard deviation, and repeatability were compared. The specific nature of this reference is implicitly tied to the ASTM E1965-98:2016 and ISO 80601-2-56:2017 standards, which typically involve highly accurate reference thermometers.
8. The sample size for the training set
The document does not describe a "training set" as would be relevant for machine learning models. The clinical study described is for validation, not training.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for a machine learning model.
§ 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.