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Rubicon Control Support Catheter is intended to facilitate placement and support of guidewires and other interventional devices within the peripheral vasculature and to allow for exchange of guidewires, and provide a conduit for the delivery of saline or contrast solutions.

The Rubicon™ Control Support Catheter is a sterile, single use, single lumen, over the wire (OTW) device designed for use in the peripheral vasculature. The catheter is designed to facilitate placement and support of guidewires and other interventional devices, to allow for exchange of guidewires and provide a conduit for the delivery of saline or contrast solutions. The shaft design is a tri-layer extrusion with a braided middle layer. There are three (3) radiopaque markerbands spaced equally along the distal most markerband is approximately 2 mm away from the distal end of the catheter tip to aid in positioning the system during the procedure. The distal 40 cm portion of the catheter is coated with a hydrophilic coating to aid device insertion through the guide sheath or guide catheter is available with a straight tip and an angled tip. The catheter is available in shaft lengths 65 cm, 90 cm, 135 cm, and 150 cm compatible with 0.014'' (0.356 mm), 0.018'' (0.457 mm), and 0.035'' (0.889 mm) guidewires. The 0.035' support catheter is compatible with 5Fr sheath; the 0.014" and 0.018" are compatible with 4Fr sheath.

There are no accessories supplied with the device.

The provided text describes the 510(k) summary for the Rubicon™ Control Support Catheter. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing (mechanical and biocompatibility). It does not involve a study related to AI/algorithm performance, human-in-the-loop performance, or the analysis of medical images for diagnostic purposes.

Therefore, many of the requested criteria (e.g., acceptance criteria for AI performance, sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of medical device submission.

Here's an analysis based on the information available:

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

The document does not provide a table with quantitative acceptance criteria and reported performance values for each mechanical test. It states that "Non-clinical performance evaluations support substantial equivalence," implying that the device met the internal acceptance criteria for these tests. The types of mechanical tests performed are listed under "Mechanical testing":

• Simulated use testing
• Catheter Bond Strength
• Catheter Body Burst Pressure
• Contrast Flow Rate
• Tip Pull Test
• Torque Strength
• Particulate Evaluation
• Coating Integrity
• Shelf Life and Packaging

For Biocompatibility, the document states the evaluation was conducted to ensure the device meets "recommended biocompatibility endpoints as outlined in ISO 10993-1," listing the following tests:

• Cytotoxicity
• Sensitization
• Irritation
• Systemic toxicity
• Hemolysis
• Pyrogen Testing

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

This information is not detailed in the provided summary. The tests performed are primarily bench tests on the physical device, not on clinical data. Therefore, concepts like country of origin or retrospective/prospective data provenance are not relevant here. The sample sizes for the mechanical and biocompatibility tests are not specified.

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 is not applicable. The "ground truth" for this device's performance is established through physical measurements and chemical analyses in a lab setting, not through expert radiology reads or similar clinical interpretations.

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

This is not applicable. Adjudication methods are relevant for subjective assessments, particularly in clinical image interpretations. For mechanical and biocompatibility testing, standard laboratory protocols and quantitative measurements are used.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This submission concerns a physical medical device (catheter) and its mechanical/biocompatibility performance, not an AI algorithm.

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

This is not applicable. There is no AI algorithm component being evaluated in this submission.

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

The "ground truth" for this device is based on physical and chemical measurements against established engineering and biocompatibility standards (e.g., ISO 10993-1). It's not derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning model.

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

This is not applicable as there is no training set for an AI model.

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