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The Smith & Nephew Tablet Application is indicated for use to provide wireless control of parameters settings for compatible Smith & Nephew surgical and endoscopic devices within the operating room including cameralcamera control unit, patient information system, DYONICS POWER II Control Unit and the Werewolf Controller.

The Smith & Nephew Tablet Application is a software application that provides a Wi-Fi connection between compatible medical devices. Once connected the Tablet Application has the ability to provide limited remote control to the connected devices.

This document is a 510(k) summary for the INTELLIO Tablet Application, which primarily discusses substantial equivalence to a predicate device (K190367) based on its intended use and technological characteristics, particularly the addition of two new compatible medical devices. The document explicitly states that "Testing demonstrated that the Smith & Nephew Tablet Application has met the performance specifications and required Cybersecurity testing therefore, is substantially equivalent to the predicate device cleared in K190367." and lists "Software verification" and "Software validation" as conducted tests.

However, the provided text does not contain the specific details regarding acceptance criteria for performance, device performance metrics, sample sizes, data provenance, ground truth establishment, or multi-reader studies that you requested. It acts as a high-level summary confirming that testing was done and met specifications for substantial equivalence, but it does not elaborate on the specifics of those tests or their results.

Therefore, I cannot fulfill your request for the detailed table and study information based solely on this document. The document suggests that such performance specifications and verification/validation results exist but does not provide them within this 510(k) summary.

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