(159 days)
The Vicks® VNT200 No Touch Forehead Thermometer is a non-sterile, reusable, clinical thermometer intended for the intermittent determination of human body temperature in a "no touch" mode, using the center of the forehead as the measurement site, on people of all ages, in a home use environment.
The Vicks® VNT200 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 user's forehead, to an oral equivalent temperature. It is calibrated for non-contact use at a distance of up to 5 centimeters (2 inches) from the center of the forehead. It uses an infrared thermopile sensor with integrated thermistor mounted in the head of the thermometer for the target reading and ambient temperature reading.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) Summary for the Vicks® VNT200 No Touch Forehead Thermometer:
1. Table of Acceptance Criteria and Reported Device Performance
The non-clinical testing section (Section VIII) of the 510(k) summary provides a comprehensive table of acceptance criteria and results. Below is a summarized version focusing on key performance aspects:
| Test Name | Cited Standards | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Accuracy (In Test Mode) | ASTM E1965-98:2016, Directive 93/42 EEC, ISO 80601-2-56:2017 | In test mode, the thermometer shall be within ± 0.2°C for 34-43°C or ± 0.3°C for outside of the temperature range for blackbody temperatures at specified points (17.0, 23.0, 28.0, 29.0, 30.0, 31.0, 32.0, 33.0, 34.0, 35.0, 36.0, 37.0, 38.0, 39.0, 40.0, 41.0, & 42.0°C). | Pass |
| Accuracy as a Function of Supply Voltage | N/A | The thermometer shall have the same accuracy as D004327 - Accuracy in Body and Surface Modes while supplied 2.7V, 3.0V, and 3.3V in a 37°C and 38.5°C blackbody, and shall not be greater than 0.2°C change between any voltage range on a given unit. | Pass |
| Accuracy in Range of Environments | ASTM E1965-98:2016, ISO 80601-2-56:2017 | 1. In each of five specified environments (varying temperature and humidity), the device shall be within 0.3°C of a blackbody at 22.5°C and within 0.2°C of a blackbody at 35, 37, 41, and 42.5°C in test mode. 2. In operating mode, the displayed temperature should be within permitted accuracy stated in the protocol depending on blackbody temperature and ambient temperature. | Pass |
| Display-Out of Range and Response Time | ASTM E1965-98:2016, Directive 93/42 EEC, ISO 80601-2-56:2017 | 1. In normal operating mode, the thermometer shall display 'Lo' if reading is below 34°C and 'Hi' if reading is above 43°C. 2. Time between user pressing measure button and reading being displayed is less than 2 seconds. | Pass |
| Battery Life | N/A | The total calculated charge consumption of the thermometer in 3 years of sleep condition & 1000 readings is less than the average usable battery capacity. | Pass |
| Low Battery Indication | ASTM E1965-98:2016, ISO 80601-2-56:2017 | 1. No low battery symbol above 2.5V. 2. Low battery symbol displayed between 2.3V and 2.5V. 3. Thermometer shall not turn ON below 2.3V. 4. Accuracy maintained when low battery indicator is present. | Pass |
| Backlight Check | N/A | 1. Luminance of backlight on display greater than specified values (14cd/m2 for green, 45cd/m2 for yellow, 5cd/m2 for red). 2. Display shows corresponding backlight color for specified temperature ranges. | Pass |
| LCD Display Visibility and Readability | N/A | 1. Numerals 7mm high and 4mm wide. 2. Clearly visible from 5° above to 45° below display. 3. Clearly visible throughout display angle range in low (15-16°C) and high (39-40°C) ambient temperatures. | Pass |
| Unit Life | N/A | The thermometer shall have the same accuracy as D004327 - Accuracy in Body and Surface Modes in a 38.5°C blackbody after 10,000 work cycles. | Pass |
| Electrical Safety | IEC 60601-1 | Compliance with IEC 60601-1:2005 + A1:2012 from a 3rd party lab. | Pass |
| Biocompatibility | ASTM E1112 4.6.2.2 and 5.3, ISO 10993-1:2009 | Compliance with ISO 10993-1:2009, ISO 10993-10:2010 (Irritation and Skin Sensitization), and ISO 10993-5:2009 (In Vitro Cytotoxicity) from a 3rd party lab. | Pass |
| Electromagnetic Compatibility | IEC 60601-1-2:2015 | Compliance with IEC 60601-1-2:2015 from a 3rd party lab. | Pass |
| Software Verification and Validation | FDA Guidance, IEC 62304:2015 | "Software verification and validation testing was conducted, and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff... and the software lifecycle standard, IEC 62304:2015" | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study Test Set Sample Size: 208 subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It refers to "a pivotal study." It is a prospective study as it involves enrolling subjects and conducting measurements.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications (e.g., radiologists with 10 years of experience) used to establish ground truth for the clinical study. For a thermometer, "ground truth" for body temperature is typically established using a highly accurate reference thermometer measurement (e.g., rectal temperature for core body temperature, or a calibrated blackbody for laboratory accuracy testing) rather than expert subjective assessment of an image. The standards cited (ASTM E1965-98:2016 and ISO 80601-2-56:2017) lay out the methods for determining temperature accuracy against a reference.
4. Adjudication Method for the Test Set
Not applicable in this context. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where subjective interpretation is involved and multiple readers' opinions need to be reconciled for ground truth. For thermometer accuracy, the ground truth is often an objective measurement from a reference device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
Not applicable. This device is a thermometer, not an AI-assisted diagnostic imaging tool that would typically undergo an MRMC study comparing human reader performance with and without AI assistance. The study focuses on the device's accuracy in measuring temperature.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the majority of the "Non-Clinical Testing & Performance Data" (Section VIII) represents standalone performance of the device without human interpretation. This includes accuracy in test mode (against a blackbody), accuracy in various environments, response time, electrical safety, EMC, etc. The clinical testing evaluates its performance in actual human use, but the core measurement is automated "algorithm only."
7. The Type of Ground Truth Used
- Non-Clinical Testing: The ground truth for the non-clinical / laboratory testing (e.g., accuracy in test mode, accuracy as a function of supply voltage, accuracy in range of environments) was established using calibrated blackbody temperatures. A blackbody is a standardized thermal radiation source used to accurately calibrate and test infrared thermometers.
- Clinical Testing: For the clinical study, the ground truth for body temperature was established by comparing the device's measurements to a reference standard method for intermittent determination of patient temperature, as required by ASTM E1965-98:2016 and ISO 80601-2-56:2017. While the specific reference method isn't detailed, for clinical thermometers, this often involves simultaneous or nearly simultaneous measurements with a highly accurate rectal thermometer or other core body temperature measurement, or highly controlled environmental conditions with a known "true" temperature.
8. The Sample Size for the Training Set
This information is not provided. The document describes the "pivotal study" (clinical test set) and non-clinical testing. For a traditional medical device like a thermometer, there isn't typically a "training set" in the machine learning sense. The device is designed, calibrated, and validated based on physics and engineering principles, and then tested against established standards. If there were internal iterative design tests during development, those details are not part of this 510(k) summary. The software (MCU) was validated, but details on data used for its development are not disclosed.
9. How the Ground Truth for the Training Set Was Established
As there's no explicitly defined "training set" for an AI model in this context, this question is not fully applicable. However, for the development and calibration of the device (which broadly analogous to "training" in AI development):
- For the Device Hardware/Software: Ground truth would have been established through robust engineering principles, use of highly accurate reference temperature sources (e.g., blackbody simulators), and adherence to international standards for thermometer design and performance.
- For the Software: The software verification and validation (V&V) involved ensuring the software met its specifications and handled errors correctly, potentially using defined test cases with expected "ground truth" outputs. The document notes that the software was validated according to the FDA's software guidance and IEC 62304:2015.
In summary, the Vicks® VNT200 No Touch Forehead Thermometer demonstrates adherence to established performance standards for thermometers through a combination of rigorous non-clinical laboratory testing using objective calibrated sources and a clinical study with a sufficient sample size of human subjects. The acceptance criteria are based on recognized international and national standards for medical thermometers.
§ 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.