Search Results

The CXI™ Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

The CXI™ Support Catheter consists of a 2.3, 2.6, or 4.0 French catheter with hydrophilic coating. The catheter includes four (4) radiopaque markers to assist in fluoroscopic visualization of the catheter during use. The 2.3, 2.6, or 4.0 French catheters allow acceptance of a 0.014 inch diameter (0.36 millimeters) wire guide, a 0.018 inch diameter (0.45 millimeters) wire guide, or a 0.035 inch diameter (0.89 millimeters) wire guide, respectively. The catheter is available in four lengths: 65, 90, 135, and 150 cm, with a straight or angled distal tip.

The provided text describes a Special 510(k) for a device modification of the CXITM Support Catheter. This type of submission focuses on demonstrating that the modified device remains substantially equivalent to its predicate devices, rather than establishing a completely new claim of safety and effectiveness through extensive clinical trials. Therefore, the information provided primarily pertains to non-clinical (engineering) tests and biocompatibility rather than studies involving human subjects or AI performance.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each engineering test or biocompatibility test. It mentions that "appropriate engineering tests were also performed on aged product to ensure that the CXI™ Support Catheter meets the performance requirements throughout the duration of shelf life," implying tests were conducted on multiple samples, including those simulating aging.

• Data Provenance: The tests are described as engineering and biocompatibility tests carried out by Cook Incorporated, likely in a laboratory setting. There is no mention of human subject data, country of origin of data, or whether it was retrospective or prospective, as these are not relevant for this type of device modification submission.

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

This information is not applicable to the provided document. The "ground truth" for the engineering and biocompatibility tests would be the physical measurements and chemical analyses performed against established specifications (e.g., ISO standards). Expert consensus in a medical diagnostic sense is not involved.

4. Adjudication method for the test set

This information is not applicable. The tests are objective measurements against predetermined scientific and regulatory standards (e.g., ISO 10555-1, ISO 10993-1). There is no "adjudication" in the sense of reconciling divergent expert opinions.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This document pertains to a physical medical device (catheter) and its engineering performance and biocompatibility, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable. The device is a physical catheter, not an algorithm.

7. The type of ground truth used

The ground truth used for these tests is based on:

• International Standards: Specific sections of ISO 10555-1 (Catheters for intravascular use - Sterile, single-use catheters - Part 1: General requirements) and ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
• Engineering Specifications: Predetermined acceptance criteria based on the device's design, intended use, and expected performance under "proper clinical use" conditions (e.g., maximum pressure, maximum flow rate).
• Analytical Chemistry and Biological Assays: For biocompatibility testing, the ground truth is derived from the results of tests such as cytotoxicity, sensitization, hemolysis, etc., which are interpreted against established biological safety thresholds.

8. The sample size for the training set

This information is not applicable. As stated, this is for a physical medical catheter and involves engineering and biocompatibility testing, not machine learning or AI.

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

This information is not applicable, as there is no "training set" in the context of this device modification submission.

Ask a specific question about this device