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The Broadway 8 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system.

The Broadway 8 Catheter is a single lumen, flexible, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. It has a radiopaque marker band on the distal end and a luer hub at the proximal end. The Broadway 8 Catheter shaft has a lubricious hydrophilic coating at the distal end to reduce friction during use. It is packaged with a FastPass Delivery Assist Catheter, two rotating hemostasis valves (RHVs) and two peel-away introducer sheaths.

The FastPass Delivery Assist Catheter may be used in conjunction with the Broadway 8 Catheter to facilitate the introduction of the Broadway 8 Catheter into distal vasculature and aid in navigation to distal anatomy. The FastPass Delivery Assist Catheter has a lubricious hydrophilic coating at the distal end to reduce friction during use.

The provided text is a 510(k) summary for the Stryker Neurovascular Broadway 8 Catheter. It outlines the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence. However, this document does not describe acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML device.

The acceptance criteria tables and study details typically requested for AI/ML device performance (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, ground truth establishment by multiple experts, sample sizes for training and test sets, etc.) are not applicable to this 510(k) summary, as the Broadway 8 Catheter is a physical medical device (a percutaneous catheter), not an AI/ML software device.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance related to AI/ML metrics. The performance data provided is for physical bench testing (e.g., tensile strength, particulate, kink resistance) and an animal study assessing vascular safety, which are relevant to a catheter but not to AI/ML performance.
• Sample sized used for the test set and the data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, training set sample size, and how training ground truth was established. These details are specific to the development and validation of AI/ML algorithms and are not found in the provided document for this physical device.

The document focuses on demonstrating substantial equivalence of the catheter to a predicate device through:

• Bench Testing: Verifying physical properties, mechanical integrity, and material characteristics (e.g., Dimensional Verification, Tensile Strength, Particulate, Coating Integrity, Kink Resistance, Burst Pressure, Simulated Use Testing).
• Animal Study: Assessing vascular safety and navigation performance in a swine model compared to the predicate device.
• Biocompatibility Testing: Ensuring the materials are safe for biological interaction.

The "Conclusions" section reiterates that the device is substantially equivalent based on these aspects, not on AI/ML performance.

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