Search Results

The Behind Ear Gentle Touch Thermometer (Models V980/BET 1000) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature using behind the earlobe as the measurement site on people of all ages.

The over-the-counter Behind Ear Gentle Touch Thermometer - Models V980/ BET 1000 is a hand-held, battery powered device designed to measure human body temperature by detecting heat flow on the skin directly behind the ear lobe as a measurement site, by using the heat conduction principal and prediction. The skin area over the posterior auricular artery passing behind the earlobe is the measurement site, which is very close to the cantharid artery. These arteries carry blood to the brain and therefore the site is the best external place to measure temperature. The Behind Ear Gentle Touch Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site by heat transfer data and mathematical algorithm. The temperature reading range is from 95.0° F to 107.6° F (35°C to 42 °C) and the time of measurement is about 1 second.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states:

• "A comparison study and clinical repeatability testing was performed on the following four age groups: 0-24 months, 24 months- <5 years, 5 years- <18 years, and 18 years and older in accordance with ASTM E1965-03."
• Sample Size: The document does not explicitly state the total number of subjects (the sample size) for the clinical study. It only mentions the age groups tested.
• Data Provenance: The document does not specify the country of origin of the data. It appears to be a prospective clinical study designed to demonstrate substantial equivalence and adherence to standards.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. The study design described is a comparison study between the candidate device, a predicate device, and a reference device, focusing on accuracy and repeatability, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was done, effectively. The "KAZ Behind Ear Gentle Touch Thermometer" is a thermometer, and its performance is inherently "standalone" as it provides a direct temperature reading without human interpretation or intervention in the reading process beyond operation. The clinical study evaluated the device's accuracy and repeatability as a standalone instrument.

7. Type of Ground Truth Used

• Reference Device Comparison (Clinical Ground Truth): The "gold standard" or reference used in the clinical study was the Braun Infrared Ear 4000 Series Thermometer (K031968/K101747). This acts as the clinical ground truth for comparison.

8. Sample Size for the Training Set

The document describes a clinical validation study, not a study involving a training set for an AI or machine learning model. The device uses a "mathematical algorithm" and "predictive algorithms" but does not explicitly describe a machine learning model that would require a separate training set. Therefore, information about a training set size is not applicable or not provided in this context.

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

Since there is no explicit mention of a training set or a machine learning model, this information is not applicable or not provided. The "predictive algorithms" are likely based on established heat transfer principles and calibration data rather than a machine learning training process with an explicitly defined "ground truth" for training.

Ask a specific question about this device