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The CenterCross ULTRA 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 Ultra Catheter is a sterile, 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 Ultra Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A key element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall 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 Ultra Catheter in and of itself does not provide therapeutic beyond simple facilitation of guidewire and device support. The CenterCross Ultra Catheter is similar in its design and achieves its intended use by means of the same mechanisms as the predicate device.

This document is a 510(k) premarket notification for the Roxwood Medical CenterCross Ultra Catheter. As such, it is focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study where acceptance criteria for a novel device performance were established and met.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number and qualifications of experts, adjudication method, MRMC study, training set information, and direct effect size of AI improvement) are not applicable to the information provided in this document. This document describes bench testing for performance and characterization, not clinical study results evaluating diagnostic accuracy or reader performance with an AI device.

Here's an extraction of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in a manner typical for a clinical study with specific metrics like sensitivity, specificity, or reader improvement. Instead, it states that "All testing was performed in accordance with recognized standards" and the "collective results of the non-clinical testing demonstrate that the CenterCross Ultra Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device."

The types of testing performed and confirmed to meet specifications are:

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This document refers to bench testing of a medical device, not a study involving human subjects or data collected from patients. Therefore, there is no "test set" in the context of patient data, nor data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for a device's physical and mechanical performance is established through engineering specifications and recognized testing standards, rather than expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to human reader studies where disagreement needs to be resolved.

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 conventional medical device (catheter), not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the device performance is based on established engineering specifications, recognized industry standards, and relevant regulatory requirements for the physical, mechanical, and biological properties of percutaneous catheters. This includes objective measurements of dimensions, forces, material integrity, and biological safety as detailed in the testing categories.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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The CenterCross Ultra 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 Ultra 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 Ultra Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A kev element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall 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 Ultra Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire and device support. The CenterCross Ultra Catheter is similar in its design and achieves its intended use by means of the same mechanisms as the predicate device.

The provided text describes a 510(k) premarket notification for the CenterCross Ultra Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the CenterCross Catheter (K140910). The information provided is primarily focused on non-clinical bench testing to show that the new device performs to specifications and is comparable to the predicate.

Here's an analysis based on the categories requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria or detailed numerical performance results for the CenterCross Ultra Catheter. Instead, it states that "All testing was performed in accordance with recognized standards" and "The collective results of the non-clinical testing demonstrate that the CenterCross Ultra Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device."

Summary of Tested Aspects:

2. Sample Size Used for the Test Set and Data Provenance

The document only mentions "Extensive bench testing" but does not specify the sample sizes (n) for each of the non-clinical tests conducted.
The data provenance is non-clinical bench testing, meaning it was performed in a laboratory setting. There is no information regarding country of origin or whether the data is retrospective or prospective, as these terms are typically relevant for clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the document describes non-clinical bench testing, not a study involving human subjects or expert assessment for ground truth determination. The "ground truth" for these tests would be the established engineering specifications and recognized standards themselves.

4. Adjudication Method for the Test Set

This section is not applicable as the document describes non-clinical bench testing. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert opinions or outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission focuses on non-clinical bench testing to demonstrate substantial equivalence, not a clinical study involving human readers and AI assistance.

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

This section is not applicable. The device is a medical catheter, not an algorithm or AI. The testing described is bench testing of the physical device.

7. The Type of Ground Truth Used

For the non-clinical bench tests, the "ground truth" is implicitly the established engineering specifications and recognized industry standards that the device was tested against. The document states, "All testing was performed in accordance with recognized standards."

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical catheter, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This section is not applicable for the same reason as above; it is a physical device, not an AI model.

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