(101 days)
The Medtronic Fusion Compact computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
The FUSION Compact™ system is a surgical guidance platform that supports use of special application software and associated instruments. The system reformats patient-specific CT or MR images acquired before surgery and displays them on-screen from a variety of perspectives (axial, sagittal, coronal). During surgery, the system tracks the position of specialized surgical probes in or on the patient anatomy and continuously updates the probe position on these images.
While the surgeon's judgment remains the ultimate authority, real-time positional information obtained through the FUSION Compact™ system can serve to validate this judgment as well as guide.
The FUSION Compact™ is an Electromagnetic-based navigation system, also known as an Image Guided System (IGS), which consists of clinical navigation software, a referencing system and platform/computer hardware. Navigation tracks the position of navigated instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. The FUSION Compact™ system is modular and designed for use in medical office or operating room environments to conduct ENT procedures including Endoscopic Skull Base, Lateral Skull Base, and Functional Endoscopic Sinus Surgery (FESS) procedures. The FUSION Compact™ will utilize a monitor and PC all-in-one computer and a free-standing emitter holder option. The system supports the FUSION Compact™ 1.0 software application. The FUSION Compact™ will interface with the existing Electromagnetic (EM) localization system and existing ENT instruments.
The Medtronic FUSION Compact™ Navigation System is a surgical guidance platform used for precisely locating anatomical structures in ENT procedures. The information provided outlines the system's acceptance criteria and the studies conducted to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Accuracy | Maximum error ≤ 3.0 mm at 95% confidence and 99.5% reliability. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that accuracy testing evaluated the FUSION Compact's 3D positional accuracy. The "upper bound of the tip error data" was determined by statistical data analysis. However, it does not specify the exact sample size for the test set (e.g., number of measurements, number of instruments tested).
The data provenance is described as "a pegboard in a surgical office and OR simulated environment with all of the typical instruments and equipment seen in those environments." This indicates that the testing was conducted in simulated environments rather than with actual patient data. The country of origin of this simulated data is not specified.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
The document does not provide information on the number of experts used to establish ground truth for the accuracy testing or their qualifications. Given that the testing involved a "pegboard" and simulated environments, it's unlikely that clinical experts were directly involved in establishing ground truth for individual measurements, but rather for defining the performance requirements.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method for the test set. Since the accuracy testing involved measuring the device's performance against a known physical standard (a pegboard), an adjudication method in the context of human interpretation would not be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focused on the standalone performance of the device's accuracy.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The "Accuracy Testing" described directly evaluates the algorithm embedded within the FUSION Compact™ Navigation System without human intervention for the measurement itself. It states: "Accuracy Testing was conducted to ensure that the FUSION Compact met the prescribed requirement for accuracy. The FUSION Compact System demonstrates performance in 3D positional accuracy with a maximum error ≤ 3.0 mm."
7. Type of Ground Truth Used:
The type of ground truth used for the accuracy testing appears to be based on a physical standard or a precisely measured reference geometry, implied by the use of a "pegboard." This means the ground truth was a known, objective measurement rather than expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
The document does not provide information regarding the sample size for a training set. The descriptions focus on the testing of the final device's performance. As this is a navigation system primarily relying on electromagnetic tracking and image registration rather than machine learning on large clinical datasets, a "training set" in the typical sense of AI/ML might not be applicable or explicitly documented here.
9. How the Ground Truth for the Training Set Was Established:
Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not provided.
§ 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).