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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 with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The CXI" Support Catheter will be available in catheter sizes of 2.6 and 4.0 French and with catheter lengths of 65, 90, 135, and 150 centimeters. The catheters will be supplied sterile and are intended for one-time use.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CXI™ Support Catheter:

Summary:

The provided text describes a 510(k) premarket notification for the CXI™ Support Catheter. The core of the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (CXI™ Support Catheter, K072724). This means the acceptance criteria are primarily focused on showing that the new device performs at least as well as, and is as safe and effective as, the predicate device, despite minor modifications in available sizes and coaxial use. The study presented is an animal study.

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document doesn't explicitly state quantitative "acceptance criteria" for each performance parameter (e.g., "pushability must exceed X newtons"). Instead, it states that the overall testing showed the devices were "adequate or better" in these parameters, supporting the claim of substantial equivalence. This is common in 510(k) submissions where comparison to a predicate is key.

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

• Sample Size: The document does not specify the exact sample size (number of animals or trials). It simply states "Animal Testing."
• Data Provenance: The study was "Animal Testing," implying it was conducted in a controlled laboratory setting. The country of origin is not specified, but given the company (Cook Incorporated) is based in Bloomington, Indiana, USA, it's highly probable the testing was conducted within the USA or under US regulatory guidelines. It is a prospective study, as it describes tests performed to demonstrate performance.

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

This type of information is generally not applicable to a preclinical animal study involving medical devices like catheters. The "ground truth" here is the direct, observable physical performance of the catheter in the animal model. The assessment of "adequate or better" would likely have been conducted by the study investigators (engineers, veterinary staff, and potentially physicians) based on predefined metrics or observations relevant to catheter performance. The document does not specify the number or qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable in the context of this preclinical animal study. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or data by multiple human experts, where there can be inter-reader variability. Here, the performance metrics are physical characteristics directly observed or measured during the animal procedure.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. An MRMC study involves human readers (e.g., radiologists) interpreting cases with and without AI assistance to measure differences in diagnostic accuracy or efficiency. The provided submission is for a medical device (catheter) and relies on preclinical (animal) testing to demonstrate substantial equivalence, not a diagnostic AI algorithm.

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

No, this question is not applicable. The device in question is a medical catheter, not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The ground truth used for the animal testing was the direct, observable and measurable physical performance of the catheter in the animal model, as assessed against expected performance parameters for such a device (e.g., ease of introduction, pushability, trackability, flexibility, torquability, withdrawal, and post-use integrity). This is a form of empirical ground truth based on experimental observation.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument (catheter), not a machine learning model. Therefore, there is no "training set" in the context of AI. The "training" in manufacturing of such devices refers to internal process validation and quality control, not data-driven model training.

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

This question is not applicable as there is no training set in the context of an AI device.

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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.

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Intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures including peripheral use.

The Cxi Support Catheter consists of a 2.6 French catheter with hydrophilic coating. The catheter includes four (4) radiopaque markers to assist in fluoroscopic visualization of the catheter during use. The inner diameter allows acceptance of a 0.018-inch (0.45mm) wire guide. The catheter is available in two lengths, 90 and 150 cm, with a straight or angled distal tip.

The provided text is a 510(k) Premarket Notification for the Cxi Support Catheter. It describes the device, its intended use, and its substantial equivalence to predicate devices, but does not describe an AI/ML powered device, an algorithm, or a study involving human readers or expert ground truthing.

Therefore, I cannot provide information on:

• Acceptance criteria for an AI/ML device or its reported performance. The "acceptance criteria" discussed in the document refer to design verification tests for a physical medical catheter.
• Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth for an AI/ML device. These concepts are not applicable to the physical catheter described.
• Sample size for training set or how ground truth was established for a training set. Again, these relate to AI/ML development, which is not the subject of this document.

However, I can extract the information relevant to the medical device (Cxi Support Catheter) as presented in the document, which pertains to its physical and functional characteristics.

Here's the relevant information from the document regarding the device's testing:

1. Table of Acceptance Criteria (Test Performed) and Reported Device Performance (Implied as "Met")

The document lists the tests performed, implying that the device met the requirements for these tests to assure reliable design and performance. Specific numerical acceptance criteria or detailed performance metrics are not provided in this summary.

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

• Sample Size: The document does not specify the sample size used for any of the listed tests.
• Data Provenance: The tests were conducted by Cook Incorporated. The document does not specify the country of origin of the data beyond that it was generated internally by the manufacturer for regulatory submission in the USA. These appear to be retrospective tests conducted on manufactured product samples.

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

This concept is not applicable. The tests performed are engineering and biocompatibility tests on a physical device, not interpretative tasks requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication is typically for interpretative clinical data, not for objective engineering or material property tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, not for a physical catheter.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the tests involved engineering specifications, material standards, and possibly biological safety standards. For example:

• Freedom of Leakage, Burst Pressure, Tensile Strength, Bending, Flow Rate: These would be compared against pre-defined engineering design specifications and performance limits.
• Biocompatibility: This would be assessed against recognized biocompatibility standards (e.g., ISO 10993 series), potentially using in vitro or in vivo testing to determine lack of toxicity, irritation, etc.

8. The Sample Size for the Training Set

This concept is not applicable. There is no AI/ML model or "training set" for a physical catheter.

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

This concept is not applicable.

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