(61 days)
BrainLAB's NaviVision is an add-on system for the Siemens mobile x-ray system Siemens Arcadis Orbic, including the 3D option Arcadis Orbic3D, and the Siemens mobile x-ray system Siemens Arcadis Varic. The NaviVision system is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, for which imaging using the Siemens mobile x-ray system has been cleared, and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image and/or image data-based model of the anatomy.
NaviVision is a device that allows surgical planning and navigation on datasets acquired with digital Siemens Carms. No extra navigation platform is required in the surgical theatre, since the BrainLAB navigation computer is built in the Siemens C-arm trolley. NaviVision links a surgical instrument, (tracked by passive marker sensor system) to a virtual computer image, which is either based on an intraoperative patient's intraoperatively acquired 2D fluoro image with a digital Siemens C-arm. The device enables the navigation based on 3D scan data and / or based on acquired fluoro images. Based on 2D fluoro images, the registration is done automatically by using the exact spatial position information of the intra-operatively acquired fluoro images. Based on 3D data, the registration is also done automatically by using the exact spation information of the start position of the scan. Beforehand, the 3D Siemens C-arm has to be calibrated in combination with the navigation system. For 3D data, the paired point matching is also available as a re-registration method. Re-registration is a method to regain the navigation accuracy in case of a movement of the patient's reference. By using this option, another 3D scan is not necessary.
The provided text describes the NaviVision system, but it does not contain a detailed study report that includes specific acceptance criteria and a demonstration of how the device meets those criteria with performance metrics.
The document primarily focuses on:
- Device identification and classification: Trade name, common name, predicate device identification, regulatory class, and product codes.
- Intended Use/Indications for Use: What the device is designed to do and for what medical conditions it's appropriate.
- Device Description: How the device works (linking surgical instruments to image data, auto-registration based on 2D fluoro or 3D data).
- Substantial Equivalence Statement: A general declaration that the device has been verified and validated according to BrainLAB's procedures and found substantially equivalent to predicate devices. This statement implies that safety and effectiveness have been proven, but doesn't present the evidence.
- FDA Correspondence: The FDA's letter confirming substantial equivalence.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, or MRMC study details from the provided text.
The closest the document comes to "acceptance criteria" is the general statement about "verification and validation according to BrainLAB's procedures for product design and development," which "proves the safety and effectiveness of the system." However, the specific metrics and thresholds for "safety and effectiveness" are not listed.
§ 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).