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Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E, VT-601F) is infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

The Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E . VT-601F) is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature. The Valeo VT-601D IR Forehead/ Ear Thermometer can measure human body temperature in 2 ways: (1) The temporal artery over forehead. (2) Tympanic temperature via the human ear. The Valeo VT-601E IR Ear Thermometer measures human body temperature natural thermal infrared radiation emitted from the ear tympanic. The Valeo VT-601F IR Forehead Thermometer measure human body temperature by the temporal artery over forehead. Operation is based on the measuring of the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear tympanic.

Here's a breakdown of the acceptance criteria and study information for the Valeo VT-601 Series IR Thermometer, 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: Not specified directly in the provided text. The document mentions "A Clinical Test Report conducted according to ASTM E 1965: 1998 (2009)" but does not detail the number of subjects or measurements.
• Data Provenance: The study was "performed by the manufacturer." The country of origin is not explicitly stated for the study data itself, but the manufacturer (VALEO Corporation) is based in Taipei, Taiwan. The study is retrospective in terms of being a report of past activity, but the study itself (the clinical test) would have been prospective to gather the data.

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

This information is not provided in the text. As this is a medical device for measuring temperature, the "ground truth" would likely be established by a reference thermometer or highly accurate clinical measurement standards, rather than expert judgment in the human-reader sense.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Temperature measurements are typically compared directly to a "gold standard" reference, without the need for human adjudication between multiple readers of the device's output.

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:

This is not applicable. The device is an infrared thermometer, not an AI-powered diagnostic imaging tool that assists human readers.

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

The device is a standalone algorithm/device. Its performance is evaluated on its own ability to measure temperature. The accuracy criteria listed above define its standalone performance.

7. The Type of Ground Truth Used:

The ground truth used for assessing accuracy was based on the "method recommended in ASTM E1965 standard." This standard specifies methods for determining the accuracy of clinical thermometers, which typically involves comparing the device's readings against a reference thermometer (a highly accurate and calibrated device) in a controlled environment, and/or against a subject's core body temperature measured by an invasive "gold standard" method in clinical trials. Therefore, the ground truth is derived from a standardized clinical measurement method.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. The Valeo VT-601 Series IR Thermometer is a physical device based on infrared sensing technology, not a machine learning model that requires a training set.

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

This information is not applicable and therefore not provided. As stated above, the device does not use a "training set" in the context of machine learning. The device's design and calibration would be based on engineering principles and physical laws of infrared radiation, validated against established measurement standards like ASTM E1965.

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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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The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.

The Radiant Innovation Inc., Infrared Ear Thermometer, Models THK09, IRT 3020 are electronic thermometers that use an infrared detector (thermopile detector) to detect body temperature using infrared radiantion from the auditory canal. Its operation is based on measuring the natural infrared thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.

To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is amplified by hardware and processed by the microprocessor. The temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.

Here's a breakdown of the acceptance criteria and the study details for the Radiant Innovation Infrared Ear Thermometer (Models THK09, IRT 3020) based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a clinical evaluation to ascertain the accuracy of the THK09 Infrared Ear thermometer.

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

   • The document does not explicitly state the sample size (number of participants or measurements) used for the test set.
   • The data provenance is not specified (e.g., country of origin). The study is described as a "clinical evaluation," implying it was prospective, but this is not explicitly stated.

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

   • This information is not provided. The study compares the device to "legally marketed thermometers" rather than expert consensus on thermometry.

3. Adjudication method for the test set:

   • The document does not describe any adjudication method. The comparison appears to be direct against established reference thermometers.

4. 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, this was not an MRMC comparative effectiveness study. This device is a medical thermometer, and the study focuses on its accuracy against reference thermometers, not on improving human reader performance with AI. The device itself is an IR thermometer, not an AI diagnostic tool.

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

   • Yes, in a sense. The clinical evaluation assesses the performance of the THK09 Infrared Ear thermometer as a standalone device. Its measurement output is directly compared to reference devices rather than being an input to a human interpretive process.

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

   • The "ground truth" was established by two legally marketed reference thermometers in the US:
     • MC 341 Omron Digital Thermometer (K091676)
     • Braun IRT 3020 Ear Thermometer (K983295)
   • The study was conducted in accordance with ASTM E1965:2003, which defines standards for clinical accuracy of IR thermometers.

7. The sample size for the training set:

   • This device is an infrared ear thermometer, which is a hardware device with embedded software for processing, not a machine learning or AI algorithm that typically requires a distinct "training set" in the computational sense. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here.

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

   • As explained above, the concept of a training set for an AI/ML algorithm does not apply to this device. Therefore, no ground truth was established for a training set.

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