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The Vicks® VDT972 RapidRead™ Digital Thermometer is a handheld, battery-powered, predictive, digital stick thermometer intended for the intermittent determination of human body temperature orally, rectally, or under the arm, in a home-use environment for people of all ages (infants, children, and adults). It is intended to be used with a single-use, disposable probe cover for all measurements.

The Vicks® VDT972 RapidRead™ Digital Thermometer is a predictive, thermistor-based, stick thermometer capable of measuring oral, axillary, or rectal temperature in 2 to 8 seconds. It is equipped with a site selection button that requires the operator to select the desired measurement site before taking a temperature. For each measurement, it must be used with a commercially-available, single-use, disposable probe cover.

The Vicks® VDT972 RapidRead™ Digital Thermometer is a contact thermometer, using a negative temperature coefficient (NTC) thermistor embedded in a measurement tip that is in contact with the measurement site. As the thermistor changes temperature, the resistance of the thermistor also changes. This change in resistance is measured by the thermometer and converted to a measurement of the temperature of the tip of the thermometer. This temperature, following the use of the predictive algorithm, is then displayed to the end user.

The Vicks® VDT972 RapidRead™ Digital Thermometer does not use a clinical offset algorithm. clinical offset algorithms are typically used to perform a measurement on one physiological site (i.e. the forehead. temple, or ear) and represent what the equivalent measurement would be at a different physiological site (i.e. oral), had the measurement been performed at that site instead. Typically, these formulas account for ambient temperature, at a minimum, in calculating the appropriate offset. Because the Vicks® VDT972 RapidRead™ Digital Thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via the use of a clinical offset.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Vicks® VDT972 RapidRead™ Digital Thermometer

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vicks® VDT972 RapidRead™ Digital Thermometer are primarily based on demonstrating substantial equivalence to its predicate devices, especially regarding performance standards like accuracy, and compliance with relevant international standards. The study aimed to show non-inferiority in clinical performance compared to the predicate device and the "Gold Standard" reference device.

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

• Sample Size for Test Set: 165 subjects.
  • Breakdown by age group and measurement site:
    • 0 to 3 months: 13 (Axillary), 16 (Rectal), 0 (Oral) = 29 total

    • 3 to 12 months: 14 (Axillary), 14 (Rectal), 0 (Oral) = 28 total

    • 12 months to 5 years: 30 (Axillary), 28 (Rectal), 0 (Oral) = 58 total

    • 5 to 18 years: 0 (Axillary), 0 (Rectal), 25 (Oral) = 25 total

    • 18 years: 0 (Axillary), 0 (Rectal), 25 (Oral) = 25 total

• Data Provenance: The document does not explicitly state the country of origin. It describes a "multicenter" clinical investigation, implying data collected from multiple locations, likely within the same country given the FDA submission.
• Retrospective or Prospective: The study was a prospective clinical investigation.

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

The ground truth was established by a "Gold Standard" reference device, the Welch Allyn SureTemp® Plus 690 Thermometer. The study methodology describes readings taken with this device. It does not mention human experts directly establishing ground truth for individual temperature readings. The accuracy of the reference device itself is presumed to be established through its own regulatory clearances and accepted metrological standards.

4. Adjudication Method for the Test Set

The document does not detail an adjudication method for disagreements between human readers, as the primary comparison was between devices. Instead, it describes:

• For afebrile subjects and febrile subjects ≥ 5 years of age: 1 reading with the reference thermometer, followed by 3 consecutive readings with the test thermometer, and 3 consecutive readings with the predicate thermometer, at one-minute intervals.
• For febrile subjects < 5 years of age: 1 reading with each of the reference, test, and predicate thermometers, at one-minute intervals.
• The use order of test and predicate thermometers was randomized.
• Test and predicate devices were randomized to eliminate bias.

This approach focuses on direct comparison and statistical analysis of device output rather than clinical adjudication of individual readings by multiple human experts.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This study is for a digital thermometer, which is a standalone measurement device, not an AI-powered diagnostic tool requiring human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the core of the evaluation is a standalone performance assessment of the Vicks® VDT972 RapidRead™ Digital Thermometer. The predictive algorithm within the thermometer itself generates the temperature reading. The clinical study directly evaluated the accuracy and repeatability of this device's readings compared to a reference standard and a predicate device, without human intervention in the temperature measurement and display process.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth was established using an accepted "Gold Standard" reference device: the Welch Allyn SureTemp® Plus 690 Thermometer (510(k) # K030580). This reference device itself has established accuracy specifications, making its measurements the de facto ground truth for this particular study.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the clinical study. For a digital thermometer using a predictive algorithm, the "training" for the algorithm itself would likely occur during its development and calibration by the manufacturer, using a variety of temperature profiles and physiological data. This information is typically proprietary and not included in a 510(k) summary focused on clinical validation. The clinical study described here is primarily a validation study for the finished device.

9. How the Ground Truth for the Training Set was Established

As noted in point 8, the document does not provide details on a specific training set or how its ground truth was established. The "predictive algorithm" in the thermometer is mentioned, implying internal development and calibration, but the methodology for establishing ground truth for that specific algorithm's training is not detailed in this regulatory submission.

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