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The FlexPointer 1.5 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.

It 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. ENT related anterior skull base procedures.

The Fiagon Navigation - FlexPointer 1.5 is a reusable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated devices that is

• a. Navigated pointing devices (maleable, sensor within the tip)
  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)

This document describes the Fiagon FlexPointer 1.5mm, an electromagnetically navigated pointing device intended for aiding in precisely locating anatomical structures during ENT surgeries. The primary purpose of the submission is to gain clearance for a geometrically modified instrument for the existing Fiagon Navigation system (K133573).

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   95% confidence level of bench accuracy < 2mm	All 95% confidence levels were < 2mm
   Bench accuracy comparable to unmodified devices (Fiagon FlexPointer and FinePointer) with mean values of 0.9 mm and 1.2 mm	Mean bench accuracy of 1.1 mm (Standard deviation 0.27 mm)

2. Sample size used for the test set and the data provenance:

   • Sample size: Not explicitly stated. The document mentions "testing was performed" and "A mean bench accuracy of 1.1 mm (Standard deviation 0.27 mm) was measured," implying a quantitative assessment, but the number of measurements or samples is not specified.
   • Data provenance: The testing appears to be bench testing (laboratory-based simulations) performed by the manufacturer, Fiagon GmbH, presumably in Germany. The document does not indicate the use of patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The ground truth for bench accuracy testing would typically be established by precise metrology equipment or highly accurate measurement systems, not human experts.

4. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data. For bench testing, the "ground truth" is determined by the measurement instruments themselves.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This document does not mention any MRMC study or evaluation of human reader performance with or without AI assistance. The device is a "navigated pointing device" for image-guided surgery, not an AI for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • The performance data presented is for the device's accuracy in a standalone capacity (bench testing), without considering its use by a human surgeon in a clinical setting. The "algorithm" here is the electromagnetic tracking technology. The "bench accuracy" assessment is a standalone evaluation of the device's measurement capability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for the bench accuracy testing would have been established by highly precise metrological measurements using calibrated instruments designed for determining spatial coordinates, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

   • Not applicable. This device is an image-guided surgical instrument that uses electromagnetic tracking, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its accuracy is based on the physics of electromagnetism and precision manufacturing.

9. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this device.

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