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The Braun BNT400 No Touch + Forehead Thermometer is a non-sterile, reusable, clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode using the center of the forehead as the measurement site on people of all ages.

The Braun BNT400 No Touch + Forehead Thermometer is a hand-held, battery powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead, to an oral equivalent temperature when placed in contact with the subject's forehead or within one inch of 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.

Here's an analysis of the provided text regarding the acceptance criteria and the study performed for the Braun BNT400 No Touch + Forehead Thermometer:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Braun No Touch + Forehead NTF3000 Thermometer, K163516). The acceptance criteria are largely based on meeting recognized consensus standards, particularly related to clinical accuracy and safety.

• 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 |
  | EMC | 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 |
  | Ingress Protection | IEC 60601-1-11:2015:
• Ingress Protection: IP22 | Pass |
  | Shock / Drop | ASTM E1965-98:2016:
• 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 |
  | Clinical Accuracy (Bias) | ISO 80601-2-56:2017:
• 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 | Pass |
  | Clinical Accuracy (Std Dev) | ISO 80601-2-56:2017:
• Standard Deviation for test device should be equivalent to or less than the Standard Deviation of the predicate device | Pass |
  | Clinical Accuracy (Repeatability) | ISO 80601-2-56:2017:
• Repeatability for test device should be ≤ ±0.3°C | Pass |
  | Usability / Use Errors | IEC 62366-1:2015 & IEC 60601-1-6:2010:
• No more than five (5) Use Errors observed for any Critical Task | Pass |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document states that a "controlled human clinical study was conducted" and tested to "ASTM E1965-98:2016 and ISO 80601-2-56:2017." However, the specific number of subjects/measurements (sample size) for this clinical study is not explicitly provided in the given text.
• Data Provenance: The document only mentions "multi-center, randomized clinical study." It does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical study, it would be prospective, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable. For a clinical thermometer, the ground truth is typically established by comparing the device's readings against established reference temperature measurement methods (like rectal or oral temperatures in a clinical setting) using a standardized protocol outlined in standards like ASTM E1965 or ISO 80601-2-56. There isn't an "expert" consensus in the same way there would be for image interpretation.

4. Adjudication Method for the Test Set:

• Not Applicable. As mentioned above, the assessment of a clinical thermometer's accuracy involves direct comparison to a reference standard, not expert adjudication of subjective findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). This is a clinical thermometer, which is a direct measurement device. Therefore, an MRMC study was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, indirectly. The performance evaluation of the thermometer, particularly its clinical accuracy (bias, standard deviation, repeatability), represents the standalone performance of the device. The device is intended for direct temperature measurement, not as an assistive tool for a human.

7. The Type of Ground Truth Used:

• Reference Standard Temperature Measurement. The ground truth for the clinical accuracy study was established by comparing the thermometer's readings against a "reference" measurement, as stipulated by the ASTM E1965-98:2016 and ISO 80601-2-56:2017 standards for clinical thermometers. These standards typically involve comparison to an invasive, highly accurate reference thermometer (e.g., rectal probe) in a controlled clinical setting. The document states "compared to the reference."

8. The Sample Size for the Training Set:

• The document does not mention a training set sample size. Clinical thermometers, especially prior to the widespread use of sophisticated machine learning, are typically designed and calibrated based on engineering principles and validated through clinical testing, rather than "trained" in the machine learning sense. If there are internal algorithms for temperature compensation or conversion, their parameters would be derived from physical models or internal testing, not usually a distinct "training set" as understood in AI/ML contexts.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. (See point 8). If any internal calibration or algorithm tuning occurred, it would have been based on established physical laws and engineering principles, likely utilizing highly controlled laboratory conditions with reference temperature sources. The document does not describe such a process as "training."

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