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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, Models TH5XY series are electronic thermometers 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 1.CD display. The total operation takes a few sconds.

The provided text is a 510(k) summary for the Radiant Innovation Inc. Infrared Ear Thermometer TH5XY series. The document primarily focuses on establishing substantial equivalence to a predicate device based on similar intended use and characteristics, and compliance with applicable voluntary standards. It does not present a study with specific acceptance criteria and detailed device performance data in the format requested.

Therefore, many of the requested fields cannot be directly extracted from the provided text. However, I can infer some information based on the type of document.

Here's the breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The document mentions "Compliance to applicable voluntary standards includes ASTM E1965-98 and EN12470-5:2003, as well as IEC 60601-1 and EN 60601-1-2 requirements." These standards define the performance and safety requirements for clinical electronic thermometers, and adherence to them would constitute the acceptance criteria. Specific numerical values for criteria (e.g., accuracy +/- X degrees) are not explicitly stated in this summary document.
• Reported Device Performance: The document only states that "bench testing contained in this submission supplied demonstrate that the modification of TH5XY do not raise any new questions of safety or effectiveness." It does not provide the specific results of these bench tests or how they directly compare to the numerical acceptance criteria of the standards.

Without the specific numerical criteria from ASTM E1965-98 or EN12470-5:2003, and the corresponding performance data from the "bench testing," a table as requested cannot be constructed.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: The document refers to "bench testing," which typically means testing conducted in a laboratory environment, not necessarily involving human subjects from a specific country or in a retrospective/prospective study.

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

• Not applicable as the text describes "bench testing" against standards, not a clinical study involving expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as the text describes "bench testing" against standards.

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:

• No, this device is an Infrared Ear Thermometer, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

• While the device functions in a "standalone" manner (it takes a temperature reading without a human interpreting an algorithm's output), the document does not describe "standalone algorithm performance" in the context of typical AI/software device evaluations. The "bench testing" would assess the device's accuracy and adherence to standards.

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

• For a thermometer, the "ground truth" for accuracy would typically be a highly accurate reference thermometer or temperature standard used during bench testing. This is not explicitly stated but implied by compliance to accuracy standards (e.g., ASTM E1965-98).

8. The sample size for the training set:

• Not applicable. This is a hardware device, and the summary does not indicate any machine learning or AI components that would require a "training set."

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

• Not applicable (see point 8).

Summary of available information:

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