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The Tunnel CC is intended to be used with a guidewire to access discrete regions of the peripheral vasculature and to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

The Tunnel CC is a single lumen, over-the-wire endovascular catheter. The design consists of a layered tubing configuration with a hydrophilic, lubricious coating on the distal end to reduce frictional forces. The center stainless steel (SS) tubing which drives functionality including buckling resistance is cut in a continuous spiral jigsaw pattern along most of the length; it ends with longitudinal laser cuts at the distal end enabling the formation of a smooth, tapered tip that is continuous with the shaft body of the catheter. This center SS tube is sandwiched between two polymer tubes where the inside layer is PTFE and the outside layer is PEBAX. A luer hub at the user end allows flushing of saline solutions or contrast media through the inner lumen and facilitates guidewire exchanges. This device comes in 0.014", 0.018" and 0.035" guidewire compatible sizes and lengths of 90cm, 135-cm, 155-cm and 170-cm for each quidewire size.

The catheters are used to navigate tortuous peripheral vasculature while providing axial stability to enhance guidewire and device crossing of discrete lesions of the peripheral vasculature. The catheters are also used to allow for guidewire exchanges and provide a conduit for delivering saline solutions and contrast media.

The provided document is a 510(k) summary for the Tunnel Crossing Catheter (Tunnel CC). It describes non-clinical performance testing conducted to support substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithms with ground truth determination. Therefore, many of the requested categories for a study involving AI performance or human reader analysis are not applicable to this document.

However, I can extract the relevant information regarding acceptance criteria and performance data for this device as it pertains to non-clinical testing.

Here's the information based on the provided text:

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

The document mentions that the device was evaluated in nonclinical testing "in accordance with FDA's recognized standards and pre-established acceptance criteria" and that "in all instances, the Tunnel CC functioned as intended." Specific quantitative acceptance criteria are not detailed in this summary; rather, it refers to compliance with ISO standards and successful completion of various tests.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for each bench or simulated use test. It refers to "nonclinical performance testing." Data provenance is from internal testing conducted by Tractus Vascular, LLC to support the 510(k) submission. This is retrospective testing performed on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving expert-established ground truth for a diagnostic task. The testing involved objective physical and performance characteristics of a medical device according to established engineering and medical device standards.

4. Adjudication method for the test set

Not applicable. There was no adjudication process as it was not a diagnostic study requiring interpretation of results by multiple experts.

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 not an AI-assisted diagnostic device or an MRMC study.

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

Not applicable. This is not an algorithm-only device. It is a physical medical device.

7. The type of ground truth used

For the non-clinical performance tests, the "ground truth" essentially refers to:

• Compliance with recognized standards: ISO 10993, ISO 10555-1, ISO 594-1.
• Meeting pre-established design specifications: For characteristics like tracking, flexibility, torquability, guidewire exchange, buckling resistance, kink resistance, and ability to cross a mock lesion. This would be determined by objective measurements and functional tests against engineering requirements.
• Equivalency to predicate devices: The primary goal of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate.

8. The sample size for the training set

Not applicable. There is no training set for an algorithm as this is a physical medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

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