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The Skyway Support Catheter is to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature and to facilitate placement of guidewires and other interventional devices.

The Skyway Support Catheters are 3F O.D. catheters that taper to a 1.9F tip and are compatible with a 0.014" standard guide wires. The Skyway catheters have a working length of 130-135cm and contains positioning markers at 95 and 105cm which provide a visual indication of the relative positions of Skyway and the end of a standard 105cm guide catheter. A single radiopaque markerband at tip of the catheter provide for a radiographic means of locating the tip position. The softer, distal end of the catheter is coated with a hydrophilic coating to assist passage through the guide catheter and vessels while the proximal end of the catheter contains a strain relief and a standard luer hub. The catheters are provided in both an over-the-wire (OTW) and rapid exchange (RX) versions. The RX version has a uniquely designed RX port to facilitate exchange of short guidewires. A 120cm stiffening mandrel is included with the Skyway RX version to provide support and pushability.

The provided document is a 510(k) premarket notification for the Skyway™ Support Catheter. It indicates that no clinical evaluations of this product have been conducted. Therefore, it is impossible to provide the requested information about acceptance criteria and a study proving the device meets them, as such a study was not performed.

The submission relies on non-clinical testing and substantial equivalence to predicate devices (Lumend Percutaneous Catheter and Quick-Cross Catheter) to establish safety and effectiveness.

Here's a breakdown of why the requested information cannot be provided based on the given text:

1. A table of acceptance criteria and the reported device performance: Not available. The document states, "Testing conducted included assessments of the design verification of the Skyway Support Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Skyway Support Catheter for its intended use." However, specific acceptance criteria or performance metrics are not listed.

2. Sample size used for the test set and the data provenance: Not available. No clinical test set was used. "Non-clinical testing" is mentioned, which typically refers to bench or animal studies, but no details on sample size or data provenance are provided for these.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was used.

4. Adjudication method: Not applicable, as no clinical test set was used.

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: Not applicable. This is a medical device (catheter), not an AI-powered diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used: For non-clinical testing, ground truth would be established through engineering specifications, material analyses, and established testing protocols. Specific types (e.g., pathology, outcomes data) are not mentioned as they relate to clinical studies, which were not performed.

8. The sample size for the training set: Not applicable. This refers to AI/machine learning models, which are not relevant to this device submission.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission demonstrates substantial equivalence primarily through non-clinical testing (design verification and biocompatibility) and comparison to predicate devices, rather than through a clinical study with defined acceptance criteria and performance data as would be typically required for a novel device or AI software.

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