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The GuideWire 0.6 Single Use 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, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.

The Fiagon Navigation - GuideWire 0.6 Single Use is a disposable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated pointing 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).

This document is a 510(k) summary for the Fiagon Navigation - GuideWire 0.6 Single Use. It's a special 510(k) to clear a modified version of an already cleared device, primarily changing from a reprocessed device to a sterile, single-use, disposable one. Therefore, the "study that proves the device meets the acceptance criteria" largely focuses on demonstrating that the modifications do not negatively impact the device's performance or raise new safety/effectiveness concerns compared to the predicate device.

Here's an attempt to extract the requested information based on the provided text, recognizing that a 510(k) summary is designed to summarize, not provide the full detail of, the underlying studies. As such, some specific details might be less granular than typically expected for AI/software device studies.

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

The document does not explicitly state numerical acceptance criteria with corresponding reported performance for the modified device in a table format. It generally states that "Testing was performed in order to determine device precision and accuracy of the modified device" and "Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system."

However, since this is a Special 510(k) for a modified version of a predicate device (Fiagon Navigation - Guidewire 0.6, K160369), the implied acceptance criterion is that the modified device's performance (precision, accuracy, functionality) must be comparable to or not worse than the predicate device. The conclusion states: "the GuideWire 0.6 Single Use has been shown to be substantially equivalent to the comparable device GuideWire 0.6 and the modified device does not present any new issues of safety or effectiveness." This implies the tests successfully demonstrated this equivalency.

Therefore, we can infer the following (with details inferred or generally stated due to lack of specificity in the summary):

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

The document does not specify the sample size used for the test set, the country of origin of the data, or whether it was retrospective or prospective. It generally refers to "Testing was performed."

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)

This section is not applicable (N/A) as the device is a stereotactic navigation guidewire, not an AI/software device that requires expert ground truth for interpretation of medical images or data. The "ground truth" for a guidewire's precision and accuracy would typically be established through physical measurements against reference standards in a controlled test environment.

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

N/A. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of performance testing for a physical medical device like a guidewire.

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

N/A. This is a physical medical device (guidewire) and not an AI/software device that would involve human readers or AI assistance for image interpretation.

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

N/A. This is a physical medical device, not an algorithm. The performance of the guidewire itself (precision, accuracy) would be evaluated in a standalone manner (without a human interpreting its output, but rather observing its physical performance or software-displayed position). The document states "Testing was performed in order to determine device precision and accuracy of the modified device."

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

For a device determining "precision and accuracy" of a physical instrument in navigation, the ground truth would typically be established by highly accurate physical measurement systems (e.g., optical tracking systems, mechanical fixtures with known dimensions, or other calibration tools) within a controlled laboratory setting. The document does not specify the exact methods but implies standard metrology for precision and accuracy.

8. The sample size for the training set

N/A. This is a physical guidewire, not an AI/software device requiring a training set.

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

N/A. This is a physical guidewire, not an AI/software device requiring a training set.

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