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The Infrared Ear thermometer is intended for the intermittent measurement of body temperature from the ear canal on people of all ages except for babies under 3 months. It is suitable for home use and healthcare facilities use.

The iHealth PT5 Infrared Ear Thermometer is a hand-held, reusable, battery operated device, which can measure human body temperature on one's ear canal. Its operation is based on measuring the natural thermal radiation from the ear canal with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. Put the probe of the thermometer into a patient's ear canal, after a self-check, pressing the activation button to start the measurement of proposed infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LED display. It is recommended that adult take the measurement instead when infants and children cannot use the ear thermometer themselves.

The iHealth PT5 Infrared Ear Thermometer measures body temperature from the ear canal. The device's performance was evaluated through non-clinical and clinical tests to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The clinical accuracy validation test included temperature readings from 129 subjects. The subjects were divided into three age groups:

• Infant group (3 months up to 1 year)
• Children group (1-5 years)
• Over 5 years old ( > 5 years)

The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. However, based on the testing being conducted to international standards (ASTM and ISO), it is likely to be a prospective clinical study specifically designed for regulatory submission.

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

This information is not explicitly provided in the document. The document states "Clinical accuracy validation test report included temperature readings," implying that a reference standard temperature measurement (often oral or rectal temperature by trained clinicians) was used as the ground truth, but the number or qualifications of experts involved in establishing this ground truth are not detailed.

4. Adjudication Method for the Test Set:

This information is not explicitly provided in the document.

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

This type of study is not applicable here as the device is an infrared ear thermometer, which measures a physical parameter (temperature) and does not involve human readers interpreting images or data to make a diagnosis that would be assisted by AI. The device operates in a standalone manner.

6. Standalone Performance:

Yes, a standalone performance study was done. The "Clinical Accuracy Validation Test" performed according to ASTM E1965-98 directly evaluated the iHealth PT5 Infrared Ear Thermometer's performance in measuring body temperature in a clinical setting without human interpretation or intervention in the temperature measurement itself. The non-clinical tests also evaluated the device's technical standalone performance.

7. Type of Ground Truth Used:

Based on the nature of a clinical accuracy validation test for thermometers, the ground truth would most likely be established by a reference standard temperature measurement (e.g., core body temperature measurements from oral or rectal thermometers) taken by trained medical personnel. This is implied by the reference to ASTM E1965-98, which outlines methods for clinical performance evaluation of intermittent thermometers.

8. Sample Size for the Training Set:

The document does not mention a training set in the context of this device. Thermometers typically rely on established physical principles and calibration, not machine learning algorithms that require a "training set" in the conventional sense. The "correction algorithm to compensate the influence of ambient temperature using a heated tip" mentioned in the device description refers to a predefined algorithm, not one trained on a dataset.

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

As there is no mention of a training set for a machine learning algorithm, this question is not applicable based on the provided text.

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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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