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The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter.

The SOLOPASS® System is a neuronavigational system that collects intraoperative ultrasound imaging referenced to a skull mounted fixation device, allowing the user to plan the desired placement for external ventricular drain (EVD). The system utilizes two-dimensional imaging data with simultaneously captured location data to build a three-dimensional model of the anatomy. Once the user has chosen a catheter placement location, the fixation device is locked in place to guide a catheter towards the intended anatomic location.

The SOLOPASS® System consists of three main sub-systems:

1. The Patient Interface Device (PID): A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter Guide.
2. The Ultrasound Probe "The Probe": A custom cranial "burr-hole" style probe used to collect intraoperative ultrasound image data from the patient.
3. The Workstation: A custom, portable unit that includes a dedicated operating system, imaging software application, and 27" monitor for displaying the User Interface. The Workstation is the primary interface of the other subsystems and is controlled by the included foot pedal.

The SOLOPASS® System provides 2mm Imaging Accuracy at 4-7cm depth and 3mm Targeting Accuracy at 6cm depth.

The provided text describes the SOLOPASS® System, a neuronavigational system that collects intraoperative ultrasound imaging and positional data to aid in the frontal placement of an intra-ventricular catheter. The document details the device's comparison to a predicate device and summarizes non-clinical testing performed to support its substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

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

The document primarily focuses on two key performance metrics related to accuracy: "System Targeting Accuracy" and "System Imaging Accuracy."

Additionally, other acceptance criteria are implicitly met by passing various tests:

• Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating, non-pyrogenic, negative for acute systemic toxicity, bacterial endotoxins

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