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The UGFT3 is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the temple (forehead); and/or underarm (axilla); and/or behind the ear as measurement sites.

The UGFT3 is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead and/or underarm and/or behind the ear as measurement sites. The UGFT3 is utilizing the Rapid Accurate Temperature Establishment (R.A.T.E.TM) technology, a technology based on the heat conduction principle, for determination of body temperature. Utilizing the R.A.T.E.TM technology, the device rapidly samples the heat flowing from the blood vessels to the skin surface. Then, based on the heat flow, the device calculates the blood vessel temperature, and then corrects this value to the body core temperature. User operation of the UGFT3 is identical to the operation of the Dual Mode Up Grade Forehead/Underarm Thermometer, cleared under K051422. The device allows user control by use of buttons located on the front panel of the device and the measured body temperature is displayed on an LCD screen, in Co or Fo units. The UGFT3 has an identical hardware as the UGFT2, as it uses the same thermistor sensor and electronic processing unit, however, the UGFT3 has a modified proprietary software algorithms. Device is made of ABS plastic and silicone rubber.

The Medisim UGFT3 thermometer is a non-sterile, reusable clinical thermometer intended for the determination of human body temperature using the forehead, underarm, and/or behind-the-ear as measurement sites. The device utilizes Rapid Accurate Temperature Establishment (R.A.T.E.TM) technology, which is based on the heat conduction principle, to determine body temperature by sampling heat flowing from blood vessels to the skin surface.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on technical accuracy according to ASTM standards and clinical validation for the new "behind the ear" measurement site.

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

• Test Set Sample Size: 239 subjects for the clinical study.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. It is implied to be prospective since it's a clinical study conducted for the validation of the new device.

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth within the clinical study. The clinical study compares the UGFT3 to a predicate device (Vicks Behind Ear Thermometer), which likely serves as the reference standard. The "ground truth" seems to be generated by a legally marketed and cleared device rather than expert consensus on individual readings.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. Given that the clinical study compares the UGFT3's readings to those of a predicate device, it's implied that the predicate device's reading acts as the reference. There's no mention of multiple readers or an adjudication process for discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. The clinical study performed was a direct comparison of the UGFT3's temperature readings to those of a predicate thermometer for the behind-the-ear site. There is no mention of evaluating how human readers' performance improves with or without AI assistance, as this is a standalone device validation, not an AI-assisted diagnostic tool.

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

The clinical study was a standalone assessment of the UGFT3's performance (algorithm and hardware). The device takes a measurement and displays a temperature. While human interaction is required to operate the thermometer, the reported "accuracy" pertains to the device's ability to measure temperature correctly, independent of a human's interpretative skill. The study directly compares the UGFT3's output to that of another thermometer, which qualifies as a standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparison to a legally marketed and cleared predicate device, specifically the Vicks Behind Ear Thermometer cleared under K103839. This serves as a reference standard for clinical accuracy. Further, technical accuracy bench testing used ASTM E-1112-00 as the standard for performance.

8. The Sample Size for the Training Set

The document makes no mention of a "training set" in the context of machine learning or AI models. The UGFT3 uses "modified proprietary software algorithms" based on a heat conduction principle, but it's not described as a machine learning model that requires a labeled training set in the typical sense. The term "training set" is not applicable based on the provided information.

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

As noted above, the concept of a training set as typically understood in machine learning/AI is not explicitly addressed. The device's "modified proprietary software algorithms" are based on a physical principle (heat conduction). It's likely that these algorithms were developed and refined through engineering, physics modeling, and potentially internal calibration data, rather than a publicly disclosed, labeled "training set" with ground truth in the context of expert annotations or pathology.

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