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The AViTA Scanéo Infrared Ear Thermometer (Model no. TS7) is infrared thermometers intended for the intermittent measurement of human body temperature by people of all ages in the home.

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This document is an FDA 510(k) clearance letter for the AViTA Scanéo Infrared Ear Thermometer. It does not contain information about the acceptance criteria or the study details you've requested.

The letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to a device already on the market. However, it does not provide the specific performance data, study design, or expert qualifications that would typically be found in a clinical study report or a more detailed submission summary.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document only provides the device's name and its intended use, but no performance metrics or specific criteria it met.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study is more common for diagnostic imaging AI, not typically for thermometers.
6. If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not mentioned.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

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