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The Smith+Nephew INTELLIO 4K CCU is intended for use in diagnostic, and operative endoscopic surgical procedures, including but not limited to, for example: orthopedic procedures, laparoscopic procedures, and otolaryngology (sinuscopic) procedures when used with an appropriately indicated endoscope.

The Smith & Nephew INTELLIO 4K CCU is a part of the Smith & Nephew visualization system. It is an all-in-one 4K imaging console and LED light source designed for endoscopic surgical procedures. The CCU is compatible with the LENS 4K Camera Head. The functional system level architecture of this device demonstrates multiple functions, that includes the illumination of surgical space and capturing of raw imaging data from the camera sensors. It also processes the imaging data and transfers it to the attached monitor for display. Apart from capturing still images and video during the procedure, the device also adjusts the visualization settings (brightness, line enhancement, color saturation/hue and image zoom) and allows optional communication to a medical tablet to facilitate centralized control of all tower devices from the tablet. The device contains of a Wi-Fi board that supports communication frequency of 2.4 GHz and 5.0 GHz. The device uses a LED light engine to illuminate the surgical space. The User Interface (UI) consists of buttons and LEDs that can be accessed on the front panel, which also contain the ports for camera head connector and USB slots for medical tablet and flash drive.

The provided text is a 510(k) summary for the Smith & Nephew Intellio 4K Camera Control Unit. It outlines the device description, indications for use, comparison to a predicate device, and non-clinical performance data.

However, the document does not contain any information regarding acceptance criteria, study details, or performance metrics in the context of device performance meeting acceptance criteria as typically seen for AI/ML device clearances. The "Non-Clinical Performance Data" section lists various engineering tests (Shock and Vibration, EMI/EMC, Safety, Packaging Design Verification) that were performed and states they "passed all acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the reported performance data for these tests.

Furthermore, it explicitly states: "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence." This indicates that no human-in-the-loop or standalone performance study, as described in your request (e.g., MRMC study, ground truth establishment, expert adjudication), was performed or provided for this 510(k) submission.

Therefore,Based on the provided text, I cannot fulfill your request for the following reasons:

• No Acceptance Criteria or Performance Data for "Device Performance" (as in clinical/diagnostic performance): The document refers to acceptance criteria for engineering tests (e.g., shock, vibration, safety), stating they passed, but it does not provide specific acceptance criteria or performance results for these tests. Crucially, it does not describe any clinical or diagnostic performance criteria or studies that would involve AI/ML components or human-in-the-loop performance.
• No Clinical Study Data: The document explicitly states "Clinical testing was not necessary for the determination of substantial equivalence." This means there is no data on:
  • Sample size for test sets
  • Data provenance
  • Number or qualifications of experts for ground truth
  • Adjudication methods
  • MRMC studies or effect sizes
  • Standalone algorithm performance
  • Type of ground truth used (clinical, pathology, outcomes)
  • Training set sample size or ground truth establishment for a training set (as no AI/ML component seeking performance clearance is mentioned).

This 510(k) focuses on substantial equivalence to a predicate device for a camera control unit and its accessories, primarily based on technological similarities and non-clinical engineering performance, not on a device that utilizes AI/ML requiring clinical performance validation as implied by your detailed request.

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