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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 < 2.15 Eu/device.
• Thermal, Electrical, Mechanical Safety: Pass IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AIM 7351731, IEC/EN 60529 (IPX7).
• Cleaning, Disinfection, Sterilization: Pass validation for cleaning and VHP sterilization of Ultrasound Probe (SAL 10^-6), and gamma sterilization of single-use PID (SAL 10^-6).
• Ship and Shelf Life Functional Test: Pass ISTA 3A, ISO 11607-1, and shelf-life aging (PID shelf life: 12 months).
• 2D Imaging Qualification: Pass verification of ultrasound requirements (imaging depth, image accuracy, active element check, and other specifications).
• Cranial Mounting Mechanical Testing: Met acceptance criteria for mean pullout strength of anchor and mean ratio of yield strength vs. insertion torque.
• Hardware Verification: Pass verification of system electrical design requirements.
• Software Verification and Validation: Pass, demonstrating that all software requirements were appropriately implemented and conformity to IEC 62304.
• Design Validation Study: Pass, user needs were successfully validated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The provided text does not explicitly state the numerical sample size for the test set for each specific performance test (e.g., how many measurements were taken for targeting accuracy, or how many units were tested for biocompatibility). The studies are listed as "Nonclinical Testing," "Verification Bench Testing," and "Design Validation," which typically imply controlled laboratory or simulated environments rather than patient data.

• Data Provenance: The studies are "Nonclinical" and "Bench Testing," suggesting they are laboratory or simulation-based rather than patient data. There is no information provided about the country of origin or whether data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

The document does not mention the involvement of experts in establishing the "ground truth" for the non-clinical and bench testing. These types of tests typically rely on highly controlled physical setups and precise measurement tools to establish ground truth, rather than human interpretation.

For the Design Validation Study, "user needs were successfully validated." While this implies user involvement, the number and qualifications of "users" (presumably clinicians or surgeons) are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. For non-clinical bench testing, adjudication methods for human interpretation are not typically used. The results are quantitative measurements against predefined criteria.

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:

No, an MRMC comparative effectiveness study was not done. The document describes a medical device for surgical guidance, not an AI/CAD system intended to assist human readers in image interpretation or diagnosis. The focus is on the device's accuracy and safety as a tool in a surgical setting.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The performance metrics like "System Targeting Accuracy" and "System Imaging Accuracy" are inherently standalone performances of the device's capabilities, measured in a controlled environment. The device provides "intra-procedural, image guided localization and navigation," which implies it provides data for human users, but the accuracy metrics presented are for the device's output itself.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For the accuracy metrics, the ground truth was established through physical measurements against known standards or reference points in controlled bench test environments. This is typical for navigations systems where accuracy is quantitatively measured directly. The document states:

• "System Targeting Accuracy: Measure targeting accuracy. Acceptance criteria defined based on Reference Device, V-Guide for Ventriculostomies (K141559)."
• "System Imaging Accuracy: Measure imaging accuracy."

This indicates that ground truth was derived from precisely measured physical setups and comparison to a known reference.

8. The sample size for the training set:

Not applicable. The SOLOPASS® System is described as a medical device for navigation and imaging, not as an AI or machine learning system that requires a "training set" in the context of model development. The software component mentioned (and verified against IEC 62304) is for operating the device and processing the imaging/positional data, not for learning from a dataset to perform interpretations or predictions.

9. How the ground truth for the training set was established:
Not applicable, as there is no mention of a training set for an AI/ML model.

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