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The Polyethylene Catheter is intended for use in angiographic procedures.

The Polyethylene Catheter, the subject of this submission, is a sterile, single use device designed for use in angiographic procedures. The Polyethylene Catheter is available in the 3.0 Fr size and is manufactured in lengths of 35, 40, 50, 55 and 65 centimeters. Each configuration includes a Luer lock adapter and a single lumen shaft.

This document is a 510(k) summary for the Cook Incorporated Polyethylene Catheter. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document mentions "test articles" and "sample size" for specific tests (e.g., biocompatibility) but does not provide exact numerical sample sizes for each test in the provided text. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. However, given that this is a 510(k) submission, the testing would typically be prospective and conducted at the manufacturer's facilities or accredited labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This document is for a physical medical device (Polyethylene Catheter) and focuses on engineering and material performance testing rather than diagnostic accuracy involving human interpretation of clinical data. Therefore, the concept of "experts" establishing a "ground truth" for a test set in the same way it would apply to an AI/imaging device is not relevant here. The "ground truth" for these tests is defined by the established international standards (e.g., ISO, BS EN ISO) and their specified methodologies and acceptance criteria.

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

Not applicable. This is not a study involving human readers or clinical interpretation requiring adjudication. Performance is assessed against predefined engineering and material standards.

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 physical medical device, 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 a physical medical device, not an algorithm.

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

The "ground truth" for the performance tests in this submission is defined by international and national standards (e.g., ANSI AAMI ISO 10993-1:2009(R)2013, BS EN ISO 10555-1:2013) that outline established methodologies, specifications, and acceptance criteria for measuring the physical, mechanical, and biological properties of medical catheters. For biocompatibility, it's about meeting the requirements of the cited ISO standard. For mechanical tests, it's about meeting the requirements and values specified in the BS EN ISO standard's annexes.

8. The sample size for the training set:

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

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

Not applicable. As above, this is a physical medical device.

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The Polyethylene Catheter is intended for use in angiographic procedures.

The Polyethylene Catheter, subject of this submission, is a sterile, single use device designed for use in angiographic procedures. The Polyethylene Catheter is available in 5.0. 6.7, 7.1. and 7.2 French sizes and is manufactured in lengths of 30 to 100 centimeters. Each configuration includes a luer lock adapter and a single lumen shaft.

The provided text is a 510(k) Pre-market Notification for a medical device called the "Polyethylene Catheter." This document focuses on demonstrating substantial equivalence to a predicate device through various performance and biocompatibility tests. It does not describe a study involving algorithms, AI, or human-in-the-loop performance. Instead, it details engineering and biological safety tests for a physical medical catheter.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for AI, training set size and ground truth establishment) are not applicable to this type of device and submission.

Here's the information that can be extracted from the provided text according to your request, with an emphasis on the parts that are directly addressed by the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified for individual tests. The document refers to "the applicable testing" for the Polyethylene Catheter, implying a sufficient number of samples were tested to meet regulatory requirements for each test.
• Data provenance: Not specified. This refers to laboratory testing of manufactured devices, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This device is a physical catheter, and the "ground truth" for its performance is established through standardized laboratory engineering and biological safety tests following international standards (ISO, ANSI). There are no human experts establishing ground truth in the sense of medical diagnosis from images.

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

• Not Applicable. See point 3. Testing results are objective measurements against established standards.

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 physical medical device, not an AI or diagnostic software.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this device's performance is objective measurement against established physical and chemical properties and biological reactions as defined by international standards (e.g., ISO 10555-1 for catheters, ISO 10993-1 for biocompatibility). These standards set the criteria for mechanical strength, leakage, dimensions, and biological safety.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning algorithm.

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

• Not Applicable. This is a physical medical device, not a machine learning algorithm.

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