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The XPS/IPC System is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

The navigated Quadcut® is a sterile, single use surgical instrument intended for the incision and removal of soft and hard tissue or bone in general otothinolaryngology, head and neck and otoneurological surgery. Quadcut® is an accessory component of the StraightShot M4 handpiece, which is an integral part of the XPS and IPC Systems. The XPS and IPC systems provide power to drive the blades during ENT procedures.

Quadcut® is intended for attachment to the M4 hand piece for use in conjunction with Fusion ENT software on a Medtronic computer-assisted surgery system. Each blade has a tracker mounted on it to allow for navigation during the ENT surgical procedure. The system's mobile emitter generates a low-energy magnetic field to locate the tracker mounted on the blade. Then, the software displays the location of the blade's tip within multiple patient image planes and other anatomical renderings.

The provided text describes the 510(k) summary for the Medtronic Navigated Quadcut®. It includes details about the device, its intended use, and comparison to predicate devices, but it does not contain information related to software performance, AI algorithms, or clinical studies involving human readers or ground truth determination in the context of AI. The performance testing mentioned is for the device's functionality and compatibility, specifically navigational accuracy, and appears to be benchtop and simulated environment testing.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment for AI/software performance cannot be extracted from this document.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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