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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 in the home setting.

The Radiant Innovation Inc., Infrared Ear Thermometer, Model TH60N is electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural 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 fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.

Radiant Infrared Ear Thermometer TH60N is an ear thermometer without probe cover with some sub-functions such as: temperature unit switchable, recall memory, scan function, last reading display, ambient temperature, and backlight.

The provided text is a 510(k) summary for the Radiant Innovation Inc. Infrared Ear Thermometer TH60N. It does not contain detailed acceptance criteria and a study proving the device meets those criteria in the way typically found for AI/ML medical devices. Instead, it focuses on substantial equivalence to a predicate device based on regulatory compliance and non-clinical testing.

Therefore, I cannot extract the specific information requested in your bullet points because the document does not contain that level of detail for a performance study.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria/Performance Standards: The document states compliance with "applicable voluntary standards includes ASTM E1965-98 and EN12470-5:2003, as well as EN 60601-1 (IEC 60601-1) and EN 60601-1-2 (IEC 60601-1-2) requirements."
  • However, it does not provide the specific quantitative acceptance criteria within those standards (e.g., maximum allowable error in temperature readings) nor does it report the device's specific performance against these criteria (e.g., "Our device had an accuracy of X degrees Celsius, which is within the Y degrees Celsius specified by ASTM E1965-98"). The document only states that "bench testing contained in this submission supplied demonstrate that the modification of TH60N do not raise any new questions of safety or effectiveness." This implies the device met the standards, but the specific data is not in this summary.

2. Sample size used for the test set and the data provenance

• Not explicitly stated for clinical performance. The document mentions "bench testing" but doesn't specify sample sizes for any clinical validation or the origin of data beyond "bench testing." For a thermometer, a "test set" would typically refer to a clinical study measuring human body temperatures, which is not described.

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

• Not applicable/Not stated. This type of information is typically for diagnostic devices where expert consensus (e.g., radiologists, pathologists) is needed to establish ground truth. For a thermometer, "ground truth" would be established by a reference thermometer or a controlled environment, not expert interpretation. This document does not describe how ground truth was established, only that it complies with standards.

4. Adjudication method for the test set

• Not applicable/Not stated. Similar to point 3, adjudication methods (like 2+1) are used for interpretive tasks in diagnostic imaging or similar fields. They are not relevant for a simple temperature measurement device like an ear thermometer.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• No. This type of study is for evaluating human performance (e.g., radiologists) with and without AI assistance in diagnostic tasks. It is not relevant for an infrared ear thermometer.

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

• Yes, in essence. A thermometer is inherently a standalone device; the "algorithm" (its internal processing) produces a direct measurement. The "bench testing" mentioned would be evaluating this standalone performance against reference standards. However, specific details of this testing (e.g., number of measurements, temperature ranges tested, results) are not provided in this summary.

7. The type of ground truth used

• Implied by compliance to standards: For a thermometer, ground truth is typically established using highly accurate reference thermometers in controlled environments (e.g., blackbody cavities for infrared calibration, or direct contact thermometry for clinical validation). The document does not explicitly state the specific ground truth used but relies on adherence to standards like ASTM E1965-98 and EN12470-5:2003 which would specify such methods.

8. The sample size for the training set

• Not applicable/Not stated. This device is a traditional electronic thermometer, not an AI/ML device that requires a "training set."

9. How the ground truth for the training set was established

• Not applicable/Not stated. As it's not an AI/ML device, there's no training set or associated ground truth for training.

In summary, this 510(k) submission focuses on meeting established regulatory standards and demonstrating substantial equivalence to a predicate device through "bench testing." It is not a clinical study report for an AI/ML device, and therefore the detailed performance metric breakdown you're looking for is absent from this specific document.

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