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The Royal Flush® Catheters are intended for the delivery of contrast media to the peripheral and coronary vasculature, not including the neurovasculature.

The Royal Flush® Catheter subject of this submission is a sterile, single use device designed for use in angiographic procedures. The Royal Flush® Catheter is available in a 3.0 French size and is manufactured in lengths of 30 to 75 centimeters. Each configuration includes a luer lock adapter, connecting cap, and a single lumen shaft.

Here's an analysis of the acceptance criteria and study information for the Royal Flush Catheter based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test. It states that "the Royal Flush® Catheter, subject of this submission, was subjected to applicable testing." The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but given the nature of device testing (mechanical, physical, and biocompatibility), these tests are typically conducted in a controlled laboratory environment.

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

This section is not applicable. The studies described are in vitro and ex vivo engineering and biocompatibility tests, not clinical studies requiring expert interpretation of patient data or images to establish a 'ground truth'. The 'ground truth' here is based on objective measurements and established international standards (e.g., ISO, AAMI).

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for human-in-the-loop studies or clinical trials where expert consensus is needed to establish ground truth from subjective data. The tests performed are objective, with results either meeting or not meeting predefined criteria.

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 section is not applicable. The Royal Flush Catheter is a medical device (intravascular catheter) for contrast media delivery, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

This section is not applicable. As stated above, the Royal Flush Catheter is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The 'ground truth' for these tests is based on objective measurements against established international and industry standards. For example:

• Biocompatibility: Adherence to AAMI ANSI ISO 10993-1:2009(R)2013 standards for cytotoxicity, sensitization, systemic toxicity, etc.
• Mechanical Tests (Tensile, Leakage, Burst): Adherence to BS EN ISO 10555-1:2013 standards.
• Dimensional Verification: Conformance to specified manufacturing tolerances.

8. The Sample Size for the Training Set

This section is not applicable. The Royal Flush Catheter is not an AI/ML device that requires a training set. The "training" for such a physical device involves robust design, materials selection, and manufacturing processes, followed by rigorous testing as described.

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

This section is not applicable for the reasons stated in point 8.

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The Beacon Tip Catheters (HNBR, SCBR, SCBR-/-SHTL) are in angiographic procedures by physicians trained and experienced in angiographic techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

The Beacon Tip Sizing Catheters (WSC, CSC, CAVA) are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. Beacon Tip Sizing Catheters have marker bands that can be used for anatomical measurements.

The Beacon Tip Catheters and Beacon Tip Sizing Catheters subject of this submission are sterile, single use devices designed for use in vascular and non-vascular angiographic procedures. There are three related but unique subfamilies of Beacon Tip Catheters, including: Beacon® Tip Torcon NB® Advantage Catheter, Slip-Cath® Beacon® Tip Catheter, and Shuttle® Select Slip-Cath® Catheter. There are three related but unique subfamilies of Beacon Tip Sizing Catheters, including: Beacon® Tip Centimeter Sizing Catheter, Beacon® Tip Cava Vessel Sizing Catheter, Beacon® Tip White Vessel Sizing Catheter. The subject Beacon Tip Catheters are available in 5.0, 5.5, 6.0 or 6.5 French sizes and are manufactured in lengths of 40 to 125 centimeters. The subject Beacon Tip Sizing Catheters are available in a 5.0 French size and are manufactured in lengths of 70 to 100 centimeters. Each configuration of the subject devices includes a luer lock adapter, connecting cap, and a single lumen shaft. The subject Beacon Tip Sizing Catheters also come with gold marker bands placed at intervals along the distal end of the catheter shaft.

I am sorry, but based on the provided text, I cannot provide the detailed information about acceptance criteria and the study that proves the device meets the acceptance criteria in the format you requested, because the provided text is a 510(k) summary for medical device clearance, not a study report.

Here's why and what information I can extract:

The document is a US FDA 510(k) Premarket Notification summary. Its purpose is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to present a clinical study proving performance against specific quantitative acceptance criteria in the way you're asking for a complex AI/human reader study.

Here's what I can tell you from the document:

• Acceptance Criteria and Reported Performance: The document states that various tests were conducted and that "The predetermined acceptance criterion was met" for most tests, or "performance parameters were acceptable for clinical use," or that values were "in accordance with the applicable values of BS EN ISO 10555-1." However, it does not provide the specific quantitative acceptance criteria or the numerical reported device performance results in a table as you requested. The document only confirms that the criteria were met.

• Sample Size for Test Set and Data Provenance: The document lists several types of tests (Acute Performance, Biocompatibility, Catheter air and liquid leakage, Cyclic bend, Dimensional verification, Dynamic and static burst, Packaging performance, Radiopacity, Tensile testing). However, it does not specify the sample sizes used for these tests, nor does it mention the country of origin or the retrospective/prospective nature of any clinical data or test sets. These are primarily engineering and bench tests, not clinical studies with patients.

• Number of Experts and Qualifications: This information is not provided as these are primarily engineering and bench tests, not studies requiring expert interpretation of clinical images or data for ground truth.

• Adjudication Method (e.g., 2+1, 3+1, none): This is not applicable and not provided for the types of tests described.

• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No MRMC study was done or mentioned. The device is a diagnostic intravascular catheter, not an AI-assisted diagnostic tool that would typically undergo such a study.

• Standalone Performance (Algorithm Only without Human-in-the-Loop Performance): This is not applicable and not provided for this type of medical device. There is no algorithm mentioned.

• Type of Ground Truth Used: For the engineering and biocompatibility tests, the "ground truth" would be the established engineering standards, material specifications, and biological testing protocols (e.g., ISO standards). It's not "expert consensus, pathology, or outcomes data" in the context of clinical interpretation.

• Sample Size for the Training Set: This is not applicable and not provided as there is no mention of an algorithm or AI model requiring a training set.

• How the Ground Truth for the Training Set was Established: This is not applicable and not provided as there is no training set.

In summary, the provided document is concerned with the safety and effectiveness of a physical medical device (catheters) based on non-clinical performance and biocompatibility testing, and its substantial equivalence to predicate devices, rather than the performance of an AI/ML algorithm against clinical acceptance criteria.

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