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The Fiagon Navigation – Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation - Extended Instrument Set ENT is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. Skull base procedures for ENT access.

The Fiagon Navigation - Extended Instrument Set ENT are reusable instruments intended to be used with the Fiagon Navigation system. The instruments in the Set are electromagnetically navigated devices that are

• Navigated suction instruments (malleable, designed to be bendable by hand, sensor a. within the tip, attachable to standard surgical vacuum suction systems)
• b. Navigated pointing devices (flexible, sensor within the tip)
• c. Registration probe (designed for non.sterile patient registration)
• d. Instrument adaptors (designed for mechanical connection to cylindric schaped surgical instruments of different diameters)

Each device incorporates a sensor device which is tracked by the navigation system with in the low-energy magnetic field of a field generator (part of the navigation system)

The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)

Here's a breakdown of the acceptance criteria and study information for the Fiagon Navigation - Extended Instrument Set ENT, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" in a numerical target format (e.g., "accuracy must be less than X mm"). Instead, it compares the device's performance to that of its predicate devices. The implied acceptance criterion is that the new device's accuracy should be comparable to or better than the predicate devices, specifically remaining under 2mm at the 95% confidence level.

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