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The Infrared Non-Contact Thermometers, ACT8100, is non-sterile, reusable clinical thermometers intended for the intermittent determination of human body temperature measured at the center of the forehead without contact. The device is intended for use on people of all ages, except pre-term babies or very small (small for gestational age). The device is intended for use in clinical and home use environments.

The Infrared Non-Contact Thermometer, ACT8100 is a hand-held device powered by batteries and designed to measure human body temperature without contacting patients. This thermometer can switch modes between forehead and ambient temperatures. The ambient temperature mode is DIRECT MODE and the forehead temperature mode is ADJUSTED MODE. The forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an oral equivalent temperature without contacting the patient's forehead. Infrared Non-Contact Thermometer, ACT8100 uses a thermopile integrated with a thermistor, a thermistor mounted on the head of the thermometer for ambient temperature readings, and an optoelectronic mechanism that focuses the infrared energy emitted from the user s forehead for the detection of noncontact use and calibration of temperature reading.

Here's a breakdown of the acceptance criteria and study information for the Infrared Non-Contact Thermometer, Model ACT8100, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the ACT8100's accuracy and measuring range "All meet ASTM E 1965-98:2009". The specific criteria for ASTM E1965-98:2009 for the full range are a bit more detailed, but the provided table summarizes the reported performance against the specified ranges.

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

The document states:

• "The three groups of subjects being tested were: (1) Infants of under 1 year old, (2) Children between 1 to 5 years old, (3) Adults"
• However, the specific number of subjects (sample size) within each group or the total sample size for the clinical study is not provided.
• Data Provenance: The country of origin for the data is not explicitly stated in the provided text. The submission is from TAIWAN (Easywell Biomedicals, Inc.), so it's likely the study was conducted there, but this is not confirmed. The study was prospective in nature, as it involved taking measurements from subjects using the device.

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

• The document does not specify the number of experts used to establish the ground truth or their qualifications.
• The ground truth was established by a "reference thermometer, Actherm Digital Clinical Thermometer ACT 2130 (K031905), either at the rectal, oral, or axillary site depending on their age group." While this is a reference device, it doesn't involve "experts" in the sense of human readers adjudicating images; rather, it's a direct measurement.

4. Adjudication Method for the Test Set

• An adjudication method (like 2+1, 3+1) is not applicable here as the ground truth was established by direct temperature measurements from a reference thermometer, not by human interpretation that requires consensus.

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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with AI vs. without AI assistance. This device is a standalone non-contact thermometer, not an AI-assisted diagnostic tool that humans would interpret.
• The study did compare the ACT8100's measurements to a predicate device (NTF 3000) and a reference standard (ACT 2130), demonstrating similar clinical biases and repeatability, but this is not an MRMC study.

6. Standalone Performance (Algorithm Only)

• Yes, a standalone performance study was done. The entire clinical evaluation detailed in Section X ("Clinical Testing") is a standalone performance assessment of the ACT8100. It directly measures the device's accuracy and repeatability against a reference standard and compares it to a predicate device without human interpretation of the device's output.

7. Type of Ground Truth Used

• The type of ground truth used was measurements from a reference standard device, specifically the "Actherm Digital Clinical Thermometer ACT 2130 (K031905), either at the rectal, oral, or axillary site depending on their age group." This is clinical measurement-based ground truth.

8. Sample Size for the Training Set

• The document does not provide information on a "training set" or its sample size. This type of non-AI, hardware-based medical device typically does not involve machine learning training sets in the same way an AI-powered diagnostic algorithm would. The device's calibration and algorithm for converting infrared readings to oral equivalent temperatures would have been developed during its R&D phase, but a distinct "training set sample size" with associated ground truth for a retrospective ML model is not applicable here.

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

• As there's no mention of a distinct "training set" in the context of machine learning, the question of how its ground truth was established is not applicable based on the provided information. The device's internal algorithms would have been developed and validated through engineering and laboratory testing, likely using controlled temperature sources and potentially clinical data, but not typically referred to as a "training set" in this context.

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