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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-

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The Braun Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical Infrared Ear Thermometers is indicated for the intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use/professional use environment respectively. The probe cover is used as a sanitary barrier between the infra-red thermometer and the ear canal.

The Braun Thermoscan® Pro/IRT 4000 series thermometer is a hand held instrument (thermometer) that measures the natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces with a built-in compensation algorithm to compensate the influence of ambient temperature using a heated tip. The Pro 4000 series thermometer is meant for professional use in hospitals and professional office settings, while the IRT 4000 series is meant for home use. The thermometer includes a probe cover that is used as a sanitary barrier between the thermometer and the ear canal to prevent any ear secretions or particulates from being transferred between different users.

Here's a breakdown of the acceptance criteria and study information for the KIU3800 (Braun Thermoscan® IRT 4000 Series/PRO 4000 Series) 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:

• Sample Size: The document does not explicitly state the exact sample size used for the statistical equivalency test. It mentions that readings were taken using "gold standard samples" and "new thermometers manufactured by the s. Mexico" (likely referring to the Juarez facility). The "Blackwelder method" for statistical equivalency was employed, which typically involves comparing two sets of measurements.
• Data Provenance: The data used for comparison came from two manufacturing sites:
  • Walldurn, Germany: Referred to as the "current" or "old" manufacturing site, providing the "gold standard samples."
  • Juarez, Mexico: The "new" manufacturing site.
  • The study is retrospective in the sense that the "gold standard samples" represent existing product batches, while the "new thermometers" were prospectively manufactured at the new site for the purpose of the study.

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

• The document does not mention the use of experts to establish ground truth for temperature measurements. The "ground truth" in this context is implicitly the measurements from the "gold standard samples" (thermometers from the original manufacturing site).
• This study is focused on demonstrating statistical equivalence between two manufacturing processes, not on the accuracy of the thermometer itself against a human physiological "ground truth."

4. Adjudication Method for the Test Set:

• Not applicable. There was no expert review or adjudication of temperature readings. The comparison was statistical between two sets of device measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• Not applicable. This device is an infrared ear thermometer, and the study described is a manufacturing site change validation study. It does not involve human readers, AI, or comparative effectiveness in that context.

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

• Not applicable in the conventional sense of a standalone algorithm for diagnostic interpretation. The device itself (the thermometer) operates without human interpretation of its measurement, directly displaying a temperature. The study focuses on the equivalence of the device's measurement performance from two different manufacturing sites, not an algorithm's standalone diagnostic capability. The internal compensation algorithms are part of the device's core function.

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

• The "ground truth" for this study was the performance of the predicate device (Braun Thermoscan® IRT 4000/PRO 4000 Series Thermometer K031928/K101747) when manufactured at the original site (Walldurn, Germany), referred to as "gold standard samples" and tested against a blackbody reference. The study's goal was to show that the new manufacturing site produced statistically equivalent thermometers.

8. The Sample Size for the Training Set:

• Not applicable. This study is a post-market submission for a manufacturing site change for an existing device. There is no mention of a "training set" as it would apply to machine learning algorithms. The device's internal algorithms were already developed and validated on prior data.

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

• Not applicable. See point 8. The existing device's ground truth for its operational algorithms would have been established during its initial development and clearance, likely through extensive clinical testing and calibration against known temperature references and potentially human body temperature data. The provided document does not detail this historical data.

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