(29 days)
The GuideWire 0.6 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)
The provided text describes the 510(k) premarket notification for the Fiagon Navigation – GuideWire 0.6. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria for a novel AI device. Therefore, much of the requested information (like multi-reader multi-case studies, expert adjudication for ground truth, or details on a training set for an AI) is not applicable or not available in this document.
However, I can extract the available performance data and infer an acceptance criterion based on the comparison to the predicate device.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bench accuracy comparable to the predicate device (mean 1.24 mm, SD 0.44 mm) | Mean bench accuracy of 1.27 mm (Standard deviation 0.4 mm) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size (e.g., number of measurements or trials) used for the bench accuracy test for the new device or the predicate. The data provenance (country of origin, retrospective/prospective) is also not mentioned, as this is a bench test, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a bench accuracy test, not a clinical study involving expert interpretation of medical images.
4. Adjudication method for the test set
Not applicable. This was a bench test.
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
Not applicable. This document describes a medical device (guidewire) used in image-guided surgery, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a guidewire, a physical instrument, not an algorithm.
7. The type of ground truth used
For the bench accuracy test, the 'ground truth' would be the known, precisely measured physical position or target, against which the device's measured position is compared. This is inherent to a bench accuracy test of a navigation device.
8. The sample size for the training set
Not applicable. This device is a physical instrument, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).