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The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.

The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles.

The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint™ Software.

The System Cart contains the Instrument Arm, electronics for the follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader-follower relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.

The Controller is the user input device on the Ion™ Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.

The Ion Endoluminal System enables optional Network and Virtual Reference features, streamlined mid-procedure restart, and enhances the control algorithm to provide an additional safety margin.

The provided text is a 510(k) summary for the Ion Endoluminal System (Model IF1000). While it describes software verification and validation, cybersecurity testing, and animal testing to demonstrate substantial equivalence to a predicate device, it does not contain specific acceptance criteria or detailed study results for an AI/algorithm's performance.

The device is primarily an electromechanical system with software for navigation and planning. The "PlanPoint™ Software" uses patient CT scans to create 3D plans, which is a software function, but the document does not treat it as a standalone AI algorithm that makes diagnoses or performs automated tasks requiring specific performance metrics like sensitivity, specificity, or AUC against a defined ground truth.

Therefore, I cannot provide the requested information in the format of a table outlining acceptance criteria and reported device performance for an AI algorithm, nor can I detail specific ground truth establishment, sample sizes for training/test sets, or information regarding multi-reader multi-case studies, as this information is not present in the provided document.

The document focuses on demonstrating that modifications to an existing device (adding support for optional network and virtual reference features, and streamlining mid-procedure restart) do not raise new questions of safety or effectiveness, and that the subject device remains substantially equivalent to its predicate.

In summary, the document you provided does not describe the kind of AI performance study details you are asking for.

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