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The Smith+Nephew INTELLIO Tablet is indicated for use to provide wired or wireless remote control of Smith+Nephew compatible surgical and endoscopic devices within the operating room including camera control unit, patient information system, mechanical resection system, fluid management system and RF coblation system. These controls consist of adjusting parameter settings only.

The INTELLIO Tablet application software is pre-installed upon a medical grade tablet that is used with compatible Smith + Nephew surgical and endoscopic device allows for control of parameters within the operating room, including camera control system, patient information system, mechanical resection system, Fluid Management system and RF Coblation system. The device also connects to the MY.INTELLIO™ cloud and provides access to medical device status, settings, images/videos, and reports before, during and after surgical procedures. Additionally, software updates are manually downloaded from the MY.INTELLIO cloud account via secured link and can be installed via the administrator account. The device is able to set parameters remotely for the Fluid management pumps, Mechanical Resection controller and RF Coblation controller by connecting to the Wifi connect device either separate (LINK box) or integrated with the individual pump or controller. It also provides a secondary control mechanism for all of these devices forming a connected system. The primary control for setting parameters are on the individual devices.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, this document is a 510(k) premarket notification letter from the FDA for a device called the "Smith+Nephew INTELLIO Tablet." It focuses on demonstrating "substantial equivalence" to a predicate device (Smith+Nephew Tablet Application cleared in K203566), rather than presenting a performance study with detailed acceptance criteria.

The "Performance Data" section (H) merely lists the types of testing performed:

• Physical Verification
• Software Verification and Validation
• Emissions and Immunity Testing
• Electrical Safety Testing

It states that "Testing demonstrated that the Smith+Nephew INTELLIO Tablet has met the performance specifications," but it does not specify what those performance specifications (acceptance criteria) were or what the reported device performance was. It also doesn't describe any clinical study or any study involving human readers or ground truth.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, reported performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided document.

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