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The devices FlexPointer 1.5 Single Use and FlexTube 3 Single Use are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The devices are indicated for use with the Fiagon Navigation system using electromagnetic navigation.

The devices are 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 Single Use and FlexTube 3 Single Use are disposable instruments intended to be used with the Fiagon Navigation system. The FlexPointer 1.5 Single Use is an electromagnetically navigated pointing device (malleable, sensor within the tip). The FlexTube 3 Single Use is an electromagnetically navigated suction device (malleable, sensor within the tip).

Each device incorporates a sensor device, which is tracked by the navigation system within 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).

The provided text describes a 510(k) submission for the Fiagon Navigation - FlexPointer 1.5 Single Use and FlexTube 3 Single Use devices. The primary purpose of the submission is to gain clearance for modified versions of previously cleared instruments, specifically a change in material and a change from reprocessed to sterile, single-use, disposable devices. The FDA's review determines substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study proving compliance, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria. However, it states the performance benchmark for accuracy.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The protocol for the bench test on the anatomical skull phantom states: "total 15 x 15 fiducial markers are touched." This indicates 225 individual measurements/trials were conducted for the accuracy testing. It's important to note this is a measure of the device's accuracy in a controlled phantom setting, not a clinical patient sample size.
• Data Provenance: The study was a bench test performed in a laboratory setting. The country of origin of the data is not specified, but the applicant, Fiagon GmbH, is based in Hennigsdorf, Germany. This was a prospective test, as it was specifically performed to demonstrate the device's performance for this regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The ground truth for the bench test was established by known positions of fiducial markers on an anatomical skull phantom. This type of ground truth does not typically involve human experts in the same way as, for example, expert radiological review. The "ground truth" here is the precisely engineered and known physical locations on the phantom.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of bench test. The comparison is between the device's reported position and the pre-defined, known position of the fiducial marker on the phantom. There is no human interpretation or adjudication involved in establishing the "correct" measurement.

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, an MRMC comparative effectiveness study was not performed. The device is a navigation instrument, not an AI-assisted diagnostic tool for image interpretation. The study focuses on the physical accuracy of the device itself.

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

The accuracy testing described is effectively a standalone device performance test. It evaluates the device's ability to accurately locate a point in space when used with the Fiagon Navigation system. While a human operator physically touches the fiducial markers, the "performance" being measured is the accuracy of the device and navigation system's calculation and display, independent of clinical human interpretation error.

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

The ground truth used was known, precisely manufactured positions of fiducial markers on an anatomical skull phantom. This is a highly controlled and objective physical ground truth.

8. The sample size for the training set

This document describes a 510(k) submission for a physical medical device (navigation instruments), not a software or AI algorithm that requires a training set in the conventional machine learning sense. Therefore, no training set sample size is applicable or mentioned.

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

As there is no training set for an AI algorithm mentioned, this question is not applicable.

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