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The MediGuide™ Technology system is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide Enabled™ (equipped with a magnetic sensor) invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

MediGuide Technology enables navigation of devices on pre-recorded X-ray images allowing the physician to reduce the duration of live X-ray during a procedure. MediGuide Technology applies 3D visualization and precise navigation to pre-recorded 2D X-ray images and can be used by the physician to perform complex electrophysiology procedures and CRT implants. MediGuide Technology is analogous to a global positioning system (GPS) in that it uses a low powered electromagnetic field to locate device-based sensors in three-dimensional space. The system uses this location information to overlay MediGuide™ Enabled/Sensor Enabled™ devices on the corresponding pre-recorded X-ray image, which allows the physician to reduce the duration of live X-ray during a procedure. MediGuide creates a real-time clinical environment by compensating for patient motion, respiration and heart rate variability

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request. The document describes the "MediGuide Technology System (Version 17.0)" and its regulatory clearance (K162643) by the FDA. It outlines the device's intended use and briefly mentions non-clinical testing.

However, it does not include:

• A specific table of acceptance criteria and reported device performance.
• Details about sample sizes for a test set, data provenance, ground truth establishment, or sample size for a training set.
• Information on the number and qualifications of experts or the adjudication method used.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone (algorithm only) performance study.

The document primarily focuses on regulatory aspects, comparison to a predicate device, and compliance with standards, rather than the specifics of a clinical or technical performance study in the way implied by your request. The "Summary on Non-Clinical Testing" section notes that "design verification activities for functional testing were performed with their respective acceptance criteria to ensure that software modifications and hardware addition do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, it does not detail these acceptance criteria or the specific results.

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