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The Spectranetics Quick-Cross Support Catheters are a guidewire exchange and infusion device designed for use in the vascular system. The catheters are intended to support a guidewire during access of the vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The Spectranetics Quick-Cross Support Catheters are intravascular catheters, available in seven (7) models:
518-032 0.014" diameter catheter, 135cm length
518-033 0.018" diameter catheter 90 cm length
518-034 0.018" diameter catheter 135 cm length
518-035 0.018" diameter catheter 150 cm length
518-036 0.035" diameter catheter 90 cm length
518-037 0.035" diameter catheter 135 cm length
518-038 0.035" diameter catheter 150 cm length

Model number 518-032 has a shaft of varying stiffness with a proximal shaft diameter of 3.0 Fr. tapering to a distal shaft diameter of 1.9 Fr.

Model numbers 518-033, 518-034, and 518-035 have a shaft of varying stiffness with a proximal shaft diameter of 3.4 Fr. tapering to a distal shaft diameter of 2.2 Fr.

Model numbers 518-036, 518-037, and 518-038 have a shaft of varying stiffness with a proximal shaft diameter of 4.8 Fr. tapering to a distal shaft diameter of 3.7 Fr.

All models have three (3) radiopaque markers located at their tapered distal tip. A standard female luer is placed on the proximal end of each model. The distal 40 cm of each model is coated with a lubricious, hydrophilic coating.

The provided text describes a 510(k) premarket notification for the Spectranetics Quick-Cross Support Catheter. This document asserts substantial equivalence to predicate devices based on non-clinical testing rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

2. Sample sized used for the test set and the data provenance:

• Sample size: Not specified.
• Data provenance: "Bench testing." The document does not specify country of origin or if the data was retrospective or prospective, as it's not a clinical study.

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

• Not applicable as this is not a clinical study involving expert interpretation of data or images. The "ground truth" for non-clinical testing would be the physical properties and performance metrics of the device itself.

4. Adjudication method for the test set:

• Not applicable, as there's no interpretation by experts involved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This is a non-clinical 510(k) submission for a medical device (catheter), not an AI or imaging diagnostic device that would typically undergo MRMC studies.

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

• Not applicable. This device is not an algorithm.

7. The type of ground truth used:

• For non-clinical testing, the "ground truth" refers to the established standards or expected performance characteristics for physical properties (e.g., tensile strength, flow rate, biocompatibility testing results). The document does not specify these standards or the specific results. It only states that the testing provided "reasonable assurance that the device will perform in a safe and effective manner."

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable.

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