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The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and contrast agents.

The MicroCross Catheter is a sterile, single lumen over-the-wire catheter to be used for the exchange and support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter also infuses and delivers saline and contrast agents.

The MicroCross Catheter consists of a catheter shaft and a proximal hub that provides strain relief. The MicroCross Catheter is offered with a working length of 155cm and is compatible with 0.018" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.

This document describes the premarket notification (510(k)) for the Roxwood Medical, Inc. MicroCross Catheter. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical targets and reported performance values for each criterion. It lists several non-clinical tests performed, implying that the device met internal specifications for each. These tests are:

The document states: "All testing was performed in accordance with recognized standards. The collective results of the non-clinical testing demonstrate that the MicroCross Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device."

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

The document does not specify the exact sample sizes used for each non-clinical test. The testing is described as "extensive bench testing," and the data provenance is implicitly from laboratory (bench) testing, not human or animal subjects. Details such as country of origin are not applicable as this relates to bench testing.

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

This information is not applicable. The device is a physical medical catheter, and "ground truth" in the context of expert review for medical image analysis or similar diagnostic devices is not relevant here. Performance was assessed via engineering and material testing standards.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical bench testing of a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic performance evaluations, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The MicroCross Catheter is a physical catheter, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted.

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

This information is not applicable. The MicroCross Catheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through adherence to recognized engineering and material standards, as well as the specifications required for the device's intended function. For example, for "Dimensional Inspection," the ground truth would be the design specifications, and the device's measured dimensions would be compared against these. For "Tensile Strength," the ground truth would be the specified minimum tensile strength, and the device's tested strength would need to meet or exceed this.

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

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

This information is not applicable, as there is no training set for this physical medical device.

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The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and contrast agents.
The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and deliver saline and contrast agents.

The MicroCross Catheter is a sterile, single lumen over-the-wire catheter to be used for the exchange and support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter also infuses and delivers saline and contrast agents.
The MicroCross Catheter consists of a catheter shaft and a proximal hub that provides strain relief. The MicroCross Catheter is offered in working lengths of 150cm and 155cm and is compatible with 0.014" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.
Subsequent to conventional guidewire placement, interventional tools such as angioplasty, stent, and atherectomy devices, may be used to provide therapeutic benefit. The MicroCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The MicroCross Catheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.

The provided text describes the MicroCross Catheter, a percutaneous catheter, and its substantial equivalence to a predicate device. However, it does not describe any clinical studies involving AI algorithms or human readers. The acceptance criteria and testing summarized are for the physical device itself, not for an AI's performance.

Therefore, I cannot provide information on the following points for an AI device based on this document:

• A table of acceptance criteria and the reported device performance for an AI.
• Sample size used for the test set and data provenance for an AI.
• Number of experts used to establish ground truth for the test set and their qualifications for an AI.
• Adjudication method for an AI test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI.
• The sample size for the training set for an AI.
• How the ground truth for the training set was established for an AI.

However, I can provide the acceptance criteria and a summary of the study for the physical device as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance (for the MicroCross Catheter)

The document lists various non-clinical tests performed to demonstrate the device's performance and substantial equivalence. The "acceptance criteria" are implied to be the established specifications met by the device during these tests, leading to a conclusion of proper functioning and substantial equivalence. Specific quantitative acceptance criteria or detailed numerical performance metrics for each test are not provided in this summary. Instead, the document states that the device "meets the established specifications necessary for consistent performance."

Study Proving Device Meets Acceptance Criteria:

The study was a series of extensive non-clinical (bench) tests conducted on the MicroCross Catheter.

Summary of the Study:

The study involved various tests designed to evaluate the physical, mechanical, functional, and biological performance characteristics of the MicroCross Catheter. These tests are listed in the table above and include assessments such as dimensional inspection, hydrophilic coating, simulated use, contrast flush injection, leak, torque strength, kink resistance & flexibility, pressurized flow rate, tensile strength, Luer compliance, corrosion, particulate, LAL, biocompatibility, sterilization adoption, and packaging and shelf-life.

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

• Sample Size: Not specified quantitatively in the document. The general term "extensive bench testing" is used.
• Data Provenance: Not applicable in terms of geographical origin or retrospective/prospective clinical data, as these were lab-based bench tests performed by the manufacturer, Roxwood Medical, Inc.

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

This is not applicable as the "ground truth" for these physical device tests is based on engineering specifications, recognized standards, and direct measurement/observation of physical properties and performance, not expert human interpretation of medical images or patient data.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review of medical cases where ambiguity exists. For bench testing, results are typically determined by established test methods and direct measurement against predefined specifications, not by consensus among human adjudicators.

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

No, this was not done as the document describes a physical medical device, not an AI algorithm.

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

No, this was not done as the document describes a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical testing was based on:

• Established engineering specifications
• Recognized industry standards (e.g., for biocompatibility, sterility)
• Direct physical measurements and functional performance evaluations (e.g., flow rates, tensile strength).

8. The Sample Size for the Training Set:

Not applicable. This device is a physical catheter, not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for this physical device.

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