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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.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "different instruments" were tested, but doesn't quantify how many instances or repetitions were performed per instrument or for the entire set.
• Data Provenance: The study was "Bench testing," indicating it was conducted in a laboratory setting. The location of the testing is not specified, but the applicant is based in Germany. The data is retrospective in the sense that it's a post-design performance evaluation, but not observational or collected from real-world clinical patient data.

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

• Number of Experts: Not applicable. This was bench testing against a known, controlled physical target, not a subjective interpretation task requiring expert consensus.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" was established by the physical setup of the bench test (e.g., precise measurement of actual position vs. navigated position), not through expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC study was not done. This device is a surgical navigation instrument, and the performance assessment described is related to its mechanical and electromagnetic tracking accuracy, not a diagnostic imaging interpretation task requiring human readers.

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

• Standalone Performance: Yes, the described "Bench testing" is a form of standalone performance evaluation. It assesses the device's inherent accuracy in tracking and displaying positions without direct human surgical intervention in a real patient. The navigation system's software and hardware (including instruments) performance are tested in a controlled environment.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by precise physical measurements in a controlled bench test environment. This likely involved highly accurate measurement tools to determine the true position of the instrument's tip, which was then compared to the position reported by the navigation system.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a navigation device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a system involves calibration and internal algorithms, which are developed and refined by the manufacturer, but not typically referred to as a "training set" in the context of regulatory submissions like this unless it's a new AI algorithm component.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a traditional training set for an AI algorithm. The device's internal calibration and algorithmic parameters would have been established during its development and manufacturing processes using engineering principles and testing against known physical standards.

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