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The No Touch + Forehead Thermometer (Model NTF3000US) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch on the centre of the forehead as the measurement site on people of all ages.

The No Touch+Forehead Thermometer ( Model NTF3000US) is a hand-held, battery powered device designed to measure human body temperature. The NTF3000 is an 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 up to two (2) inches away. The NTF 3000 thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection of contact or non-contact use and compensation of the temperature reading.

Here's a breakdown of the acceptance criteria and study information for the KAZ USA, Inc. No Touch+ Forehead Thermometer (Model NTF3000US), based on the provided text:

Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the No Touch+ Forehead Thermometer are established by its conformance to the ASTM E1965-03 standard for clinical accuracy and repeatability. The device needed to demonstrate non-inferiority or substantial equivalence to the predicate device against a gold standard.

Study Details

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document states that a comparison study was performed across four age groups: 0-12 months, 12 months- <5 years, 5 years- <18 years, and 18 years and older. However, the specific number of participants within each age group or the total number of participants in the test set is not explicitly provided in the summary. The document refers to "sections M and L for the detailed protocol and report," which would presumably contain this information.
• Data Provenance: Not explicitly stated, but it's a clinical study comparing devices, suggesting prospective data collection. The location of the study is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The ground truth was established by another medical device, the Braun Infra Red Ear Pro 4000 Series Thermometer. Therefore, no human experts were explicitly used to establish the ground truth in the traditional sense for these temperature measurements; rather, it was a comparative study against an established, legally marketed device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Since the ground truth was established by an objective measurement device (Braun Infra Red Ear Pro 4000 Series Thermometer), no human adjudication method was required or performed for the test set's temperature readings.

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 was not done. This device is a standalone thermometer, not an AI-assisted diagnostic tool that involves human interpretation.

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

• Yes, a standalone study was done. The clinical comparison study evaluated the performance of the No Touch+ Forehead Thermometer (an algorithm-driven device) directly against a reference thermometer, without human intervention in the temperature measurement process itself, beyond operating the devices. The device's measurement output is its final determination.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth was established by comparison to a legally marketed and established reference medical device: the Braun Infra Red Ear Pro 4000 Series Thermometer (K031968/K101747/K103800). This is a form of reference standard comparison.

8. The sample size for the training set:

• The document does not explicitly mention a separate "training set" sample size. As this is a 510(k) submission for a medical device (thermometer), it is likely that the device's algorithms were developed and refined during product development, possibly using internal data or engineering studies, rather than a distinct, formal "training set" in the context of a machine learning model for image interpretation. The submission focuses on the validation or clinical study to demonstrate equivalence.

9. How the ground truth for the training set was established:

• Not applicable/Not provided given the absence of a distinct "training set" described in the context of this submission. The device's operational principles (thermopile sensor, thermistors, parabolic mirror, infrared distance sensor, predictive algorithms) suggest engineering and calibration against known temperature standards during development.

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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.

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