(294 days)
The Sonowand is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. The Sonowand is intended for use as a standard neuronavigation system. The Sonowand is intended for use as a stand-alone ultrasound scanner.
Invite is an integrated neuronavigation system with intraoperative imaging capabilities. The main components of the system are a navigation computer running the Invite software application, an ultrasound scanner and a tracking system in a single rack of equipment. Invite can be used as a conventional neuronavigation system based on preoperative MR or CTimages, or as a stand-alone ultrasound scanner for real-time 2D imaging. It can also be used as a combined system where high-quality 3D ultrasound data can be transferred to the navigation system for direct navigation. Thus, the surgeon can navigate not only on a preoperative 3D map (MR or CT), but also on an intraoperative 3D ultrasound map which is only a few seconds old. The acquisition time is less than one minute, which means that the surgeon can typically update the navigation map 5-10 times during the surgery. The problem with brain shift is therefore practically eliminated. The system is contained on a trolley with lockable wheels. This trolley contains power supply, power restrictor, on/off main switch, network and USB ports, an industrial standard PC (navigation computer), the ultrasound unit (GE Vivid-i), probe interface, wiring and cabling. Attached to the trolley is a steel tube column which supports two pendant arms. One of these arms supports an infrared camera (NDI Polaris Spectra). The other arm supports a touch screen. which is the primary user interface. Invite has two functions. It supports the surgeon by showing the position of tools or pointers relative to MR, CT or Ultrasound images (which will normally show features such as brain tumors). It also makes it possible for the surgeon to acquire ultrasound images during operation which can be compared with other images (such as MR or CT) and can be used for supporting the surgeon by showing the position of tools and pointers. The control is primarily by a graphical touch screen (which can be draped). The secondary control is by a footswitch. Data sets (preoperative MR/CT and intraoperative 3D ultrasound) can be used for planning the surgery as well as to navigate in the brain. As the surgery progresses, the accuracy and value of the preoperative images will normally decrease, while ultrasound images will maintain a more precise representation of the true anatomy if these images are updated regularly. Digital snapshots of the screen can easily be stored during surgery for documentation purposes. It is also possible to review the data sets and to store images after surgery.
The provided 510(k) summary for the SonoWand Invite does not contain the detailed study information typically requested for acceptance criteria and device performance.
This document describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. It confirms that the system has been "verified and validated according to specification requirements" and "tested to and complies with all applicable EMC/EMI standards," but does not provide any specific quantitative performance metrics, clinical study design, or results related to efficacy (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance).
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics (e.g., accuracy, precision) are mentioned.
- Sample size used for the test set and the data provenance: No test set or clinical data is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set with ground truth is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, and the device is described as "a tool to aid" rather than a standalone diagnostic.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
What the document does state regarding testing:
- Summary of Testing: "The SonoWand Invite system has been verified and validated according to specification requirements. The system has been also been tested to and complies with all applicable EMC/EMI standards. Applicable testing of the ultrasound components has been performed. Results of the tests performed show the SonoWand Invite is as safe and effective as the predicate devices."
This broadly states that internal validation and verification processes were completed, and that the device meets safety standards, but it does not provide the specific performance data or study details you are asking for. This is common for 510(k) submissions focusing on substantial equivalence to predicate devices, where extensive new clinical performance data might not be required if the device's technology and intended use are similar to already cleared devices.
§ 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).