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The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

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The provided text is a 510(k) premarket notification letter from the FDA to AViTA Corporation regarding their Scaneo IR Thermometer. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document is primarily an FDA clearance letter, indicating that the device has met regulatory requirements for market entry based on substantial equivalence, rather than a detailed report of the device's technical performance study.

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