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The CenterCross Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.

The CenterCross Catheter is a sterile, single-use, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature to facilitate exchange of guidewires and other interventional devices.

The CenterCross Catheter consists of an inner shaft, outer sheath, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily expandable and retractable nitinol structure, which when deployed by the physician expands to the width of the artery to aid interventionalists in establishing greater support near the treatment site.

Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The CenterCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The CenterCross Catheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate devices.

The provided text is a 510(k) Premarket Notification for the CenterCross Catheter, which is a medical device. This type of document is a submission to the FDA demonstrating that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than establishing novel acceptance criteria or conducting studies to prove independent performance against such criteria as one might find for a truly novel device or an AI/software as a medical device (SaMD).

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance simply does not apply or is not detailed in this type of regulatory submission.

However, I can extract the information that is present:

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

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic or algorithmic device. Instead, it lists general "Nonclinical Testing Summary" categories. The "acceptance criteria" are implied to be "meeting established specifications" which allow for a substantial equivalence determination, rather than specific quantitative thresholds. The "reported device performance" is summarized as the device "meets the established specifications necessary for consistent performance for its intended use" and "functions to its specifications and intended use."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify sample sizes for non-clinical bench testing. The data provenance is "bench testing" and an "in vivo animal validation study." No human data or specific country of origin for data is mentioned, which is typical for pre-market submissions of physical devices where initial verification and validation are often done in-house or through contract labs. These are typically prospective tests performed for the purpose of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable and not provided. The testing described is primarily mechanical and material characterization, and an animal study. "Ground truth" in the context of expert medical interpretation (e.g., for imaging or diagnostic algorithms) is not relevant here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. Adjudication methods are typically used for establishing ground truth in clinical studies involving human interpretation or uncertain outcomes, not for bench testing of physical device performance.

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:

No MRMC study was conducted or is mentioned. This type of study is relevant for AI/SaMD devices that assist human readers (e.g., radiologists interpreting images), which is not the nature of the CenterCross Catheter.

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

This is not applicable as the CenterCross Catheter is a physical medical device, not an algorithm or software. Standalone performance for an algorithm is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical testing is based on established engineering specifications, recognized standards, and the expected functional performance of catheters. For the "in vivo animal validation study," the "ground truth" would be the observed physiological response and device performance within the animal model, assessed by researchers or veterinary professionals, but specifics are not detailed.

8. The sample size for the training set:

This is not applicable. "Training set" refers to data used to train machine learning models. The CenterCross Catheter is a physical device and does not involve a training set in this context.

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

This is not applicable since there is no training set for a machine learning model.

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