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The Shockwave CS Guide Catheter is intended to access the coronary venous system and may be used alone (9F) or in a dual catheter delivery (e.g., 9F with 7F). The catheter serves as a conduit for the introduction of interventional/diagnostic devices introduced into the coronary venous system.

The Shockwave CS Guide Catheter is a single lumen catheter consisting of a PTFE liner, stainless steel braid, and polymer outer jacket. The transition segments of the catheter have a gradual decrease in stiffness starting from the proximal shaft segment and ending at the distal tip. The Shockwave CS Guide Catheter features a curved distal shaft with radiopaque tip. The proximal end of the guide catheter has a standard luer fitting for connecting to a hemostasis valve. The proximal luer also includes a curve indicator to match the direction of the guide catheter tip curvature and provides a tactile and visual cue to the user. The Shockwave CS Guide Catheter is provided EO sterile and is for single use only.

The provided FDA 510(k) clearance letter for the Shockwave CS Guide Catheter does not contain the detailed information requested regarding acceptance criteria and the study proving device performance in the context of clinical or AI-assisted diagnostic performance.

The document primarily focuses on:

• Substantial equivalence to a predicate device (Boston Scientific Acuity Pro Lead Delivery System).
• Device description and indications for use.
• Non-clinical bench testing (biocompatibility, design verification, sterilization, packaging) to demonstrate engineering performance and safety.

Therefore, I cannot provide a detailed answer to most of your questions based on the input provided. The document describes a traditional medical device clearance, not one involving software/AI with diagnostic performance studies as would be typical for your detailed request.

However, I can extract the information that is present regarding the non-clinical testing.

Based on the provided 510(k) Summary, here's what can be extracted and what is NOT present:

The device in question, the "Shockwave CS Guide Catheter," is a physical medical device (a catheter) intended for accessing the coronary venous system. The performance testing described in the document is primarily non-clinical bench testing to demonstrate the physical and material properties of the catheter, its safety (biocompatibility, sterility), and its ability to function as intended (e.g., flexibility, torque strength, compatibility).

This type of device clearance typically does not involve human reader studies, AI performance metrics, or complex ground truth establishment as would be seen for diagnostic AI/software devices.

Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing):

Information NOT Present in the Document and Why (Context for AI/Diagnostic Devices):

The following points are typically relevant for AI/diagnostic software clearances, but are not applicable or detailed in this 510(k) for a physical medical catheter:

1. Sample sizes used for the test set and the data provenance: Not applicable for a physical device's non-clinical bench testing. Bench tests use defined quantities of devices or materials, not patient data sets.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to engineering specifications and performance within a laboratory setting, not clinical diagnostic accuracy.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There's no clinical "test set" requiring human adjudication as understood for AI/diagnostic studies.
4. 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 device is a catheter, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm involved.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, "ground truth" equates to engineering specifications, validated test methods (e.g., ISO standards), and pre-defined acceptable ranges for physical properties.
7. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a standard 510(k) clearance for a physical medical device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to a rigorous battery of non-clinical, benchtop engineering tests and biocompatibility assessments, rather than clinical efficacy studies or AI performance evaluations as implied by your detailed request.

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