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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

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set in the context of software or AI performance. The performance testing described is for "functionality and compatibility with the identified Medtronic products" and "navigational accuracy" using "benchtop and simulated real-life use conditions." This suggests physical device testing rather than a software-specific test set with individual cases. The data provenance (country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not available in the provided document. The study described focuses on the device's functional and navigational accuracy in a simulated/benchtop environment, not on human interpretation or expert-derived ground truth for diagnostic or image analysis tasks.

4. Adjudication Method for the Test Set

This information is not available in the provided document. As the testing pertains to device functionality and navigational accuracy, adjudication by human experts in the context of diagnostic interpretation is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted according to this document. The device in question is a surgical instrument (Quadcut®) with navigation capabilities, not an AI diagnostic or assistance tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a navigated surgical instrument. Its "performance" in terms of navigational accuracy is likely evaluated as a standalone system (the algorithm/system itself determining position) but it's used in conjunction with "human-in-the-loop" during surgery. The document does not describe the navigational algorithm as an "AI" in the modern sense but rather as a system that uses a tracker and magnetic field to display the blade's tip. There is no mention of a standalone AI algorithm evaluation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the navigational accuracy testing, the "ground truth" would likely be the actual physical position of the instrument's tip, measured by highly precise metrology equipment or a known reference standard in the benchtop and simulated environments. The document does not explicitly state the method for establishing this ground truth, but it would involve objective, measurable physical parameters. It's not related to medical expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.

8. The Sample Size for the Training Set

This information is not available as the document does not describe an AI/ML system that requires a "training set." The device is a surgical instrument with navigation capabilities based on electromagnetic tracking, not a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not available as there is no mention of a training set for an AI/ML algorithm within this document.

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