(127 days)
The Braun No Touch + Forehead NTF3000 Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode on the center of the forehead as the measurement site on people of all ages.
The Braun No Touch + Forehead NTF3000 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 two inches of the subject's forehead.
The Braun No Touch + Forehead NTF3000 Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared proximity sensor for detection of contact or non-contact use and compensation of the temperature reading.
The provided document, a 510(k) summary for the Braun No Touch + Forehead NTF3000 Thermometer, details the device's acceptance criteria and the studies conducted to prove it meets these criteria. Since this is a submission for a medical device (thermometer), the "AI" related questions are not applicable.
Here's an analysis based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document primarily refers to regulatory and performance standards rather than specific acceptance criteria values in a table. However, in the "Performance Standards" section (pages 6-7), there is a table summarizing non-clinical performance data with "Acceptance Criteria" and "Result."
Table: Non-Clinical Performance Data, Acceptance Criteria, and Results
| Performance Standard | Test Performed | Acceptance Criteria | Result |
|---|---|---|---|
| IEC 60601-1:2012: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Touch current | 100 μA NC; 500 μA | Pass |
| Patient leakage current | 10 μA NC; 50 μA SFC (d.c. current) | Pass | |
| Patient leakage current w/ mains on the F-type applied parts | 5000 μA | Pass | |
| Shock / Drop test | 1 meter | Pass | |
| IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | Electrostatic discharge | ± 8 kV contact; ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air | Pass |
| Radiated RF EM fields | 10 V/m; 80 MHz – 2,7 GHz 80 % AM at 1 kHz | Pass | |
| Proximity fields from RF wireless communications equipment | 9 – 28 V/m; 385 – 5785 MHz Multiple modulations | Pass | |
| Surges | ± 0,5 kV, ± 1 kV | Pass | |
| Rated power frequency magnetic fields | 30 A/m 50 Hz or 60 Hz | Pass | |
| IEC 60601-1-11:2015: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | Ingress protection rating | IP22 per product specifications | Pass |
| Operating / storage temperature range | -13 °F to 140 °F (-25 °C to 60 °C) per product specifications | Pass | |
| Operating / storage atmospheric pressure range | 700-1060hPA (0.7-1.06 atm) per product specifications | Pass | |
| Operating / storage relative humidity range | 15–95% non-condensing per product specifications | Pass |
The document also states the device's accuracy specifications, which can be considered acceptance criteria for temperature measurement:
- Accuracy for body temperature measurement:
- ± 0.2°C / 0.36°F for 35.0°C to 42.0°C (95.0°F to 107.6°F)
- ± 0.3°C / 0.54°F for 31.0°C to 35.0°C (87.8°F to 95.0°F)
- ± 0.3°C / 0.54°F for Above 42.0°C (Above 107.6°F)
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions a "pivotal clinical study" (page 7) but does not specify the sample size for this clinical study.
- Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state whether the clinical study was retrospective or prospective, but "pivotal clinical study" generally implies a prospective design.
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. For a thermometer, "ground truth" would typically refer to highly accurate reference temperature measurements (e.g., from a rectal thermometer or other core body temperature measurement device in a controlled setting) compared against the device's readings, rather than expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This concept is not applicable to a clinical study for a thermometer, where readings are quantitative and compared against a reference standard. Adjudication methods are typically relevant for subjective assessments, like image interpretation.
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:
- Not applicable. This device is a thermometer, not an AI-assisted diagnostic imaging tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially applicable/Implied. The non-clinical performance data (pages 6-7) represents standalone device performance under various conditions (electrical safety, EMC, environmental). The clinical accuracy testing also evaluates the device's performance directly against a reference thermometer, which is a standalone assessment of its accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical accuracy testing, the ground truth would be reference thermometer measurements (e.g., highly accurate core body temperature readings) from human subjects, as stated by its compliance with "ASTM E1965-98:2009: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature." This standard outlines methods for clinical accuracy studies, typically involving comparison to an accepted reference thermometer.
8. The sample size for the training set:
- Not applicable. This device is a traditional electronic thermometer, not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As stated above, this device does not use a training set as it's not an AI/ML 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.