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The High-Flo Silver Polyethylene Catheter is intended for the delivery of contrast media and therapeutic agents to the peripheral, carotid, and coronary vasculature, not including the neurovasculature.

The High-Flo Silver Polyethylene Catheter, subject of this submission, is a sterile, single use device designed for use in angiographic procedures. The High-Flo Silver Polyethylene Catheter is available in a 5.5 French size and is manufactured in lengths of 65 to 100 centimeters. Each configuration includes a luer lock adapter, connecting cap, and a single lumen braided shaft.

The acceptance criteria and device performance for the High-Flo Silver Polyethylene Catheter are detailed in 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 explicitly state the specific sample sizes used for each of the performance tests (e.g., number of catheters tested for tensile strength, burst pressure, etc.). It generally refers to "applicable testing" and that "the predetermined acceptance criteria were met."

The provenance of the data is internal to Cook Incorporated, as these are engineering and biocompatibility tests conducted directly on the device. It is not patient data, so concepts like "country of origin" or "retrospective/prospective" do not apply in the typical clinical study sense. These are laboratory-based, pre-market validation tests.

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

This information is not applicable to the reported tests. The ground truth for these tests is established by objective, standardized engineering and biocompatibility test methods (e.g., ISO standards) and measurable physical properties and biological responses, rather than expert consensus on a clinical diagnosis or image interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation by multiple readers to establish a ground truth for diagnostic accuracy. The tests described are objective, quantitative laboratory tests.

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:

No MRMC comparative effectiveness study was mentioned or performed. This device is a physical medical instrument (catheter), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance does not apply to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. As mentioned, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for these performance tests is based on objective, measurable criteria defined by international standards (e.g., BS EN ISO 10555-1:2013, ANSI AAMI ISO 10993-1:2009(R)2013) and the inherent physical and chemical properties of the device materials and design. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning context. The product development process involves design iterations and engineering testing, but not machine learning training.

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

Not applicable, as there is no "training set" for this physical device.

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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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