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

CrossCath Support Catheters with hydrophilic coating are single lumen intravascular catheters, designed to support a wire guide during access of vasculature, allow for exchange of wire guides, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

CrossCath Support Catheters are available in nine different configurations. All models have three radiopaque markers spaced equally along the distal shaft to aid in estimating lengths within the vascular system. The distal radiopaque maker is positioned approximately 3 mm from the catheter tip. Each model has a smaller distal portion for passing through smaller vasculature and a larger proximal portion for additional support. The models with 0.014" and 0.018" end holes have hydrophilic coating at the distal 40 cm portion. The models with 0.035" end holes have hydrophilic coating at the distal 60 cm portion.

Here's an analysis of the provided text regarding the CrossCath Support Catheter, outlining the acceptance criteria and study details based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The provided text does not explicitly state quantitative acceptance criteria for each test. Instead, it offers a general statement that the results of these tests "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." This is typical for a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting detailed test reports. The implied criteria are derived from the nature of the tests and the intended use of the device.

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

• Sample Size for the Test Set: Not specified. The document lists the types of tests performed but does not provide details on the number of units tested for each.
• Data Provenance: Not explicitly stated. The tests were performed by "Cook Incorporated," indicating they were likely internal tests; however, the country of origin of the data (e.g., in terms of where the samples were manufactured or tested) is not mentioned beyond the company's location in Bloomington, IN, USA. The study appears to be retrospective in the sense that the testing was performed on a completed device design to demonstrate its performance characteristics.

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

• Not Applicable. This device is a medical instrument (catheter), not a diagnostic algorithm that requires expert human interpretation for ground truth establishment. The "ground truth" for these tests would be objective measurements and adherence to established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is not a diagnostic device requiring human interpretation, there's no "adjudication method" in the sense of expert consensus on image or data interpretations. The tests performed are objective, measurable, and evaluated against predetermined specifications by engineers or technicians.

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 (catheter), not an AI diagnostic tool. Therefore, an MRMC study or a study involving human readers with/without AI assistance would not be relevant.

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

• Not Applicable. As mentioned above, this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used:

• For the physical tests (Tensile, Leakage, Burst Pressure, Flow Rate, Accelerated Aged): The "ground truth" is defined by engineering specifications and validated testing methodologies that ensure the device meets its functional requirements.
• For Biocompatibility Testing: The "ground truth" is established through recognized industry standards (e.g., ISO 10993) and testing protocols designed to assess biological responses to materials.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing process would involve iterative development and testing, analogous to "training" in a broad sense, but not a distinct dataset for algorithm training.

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

• Not Applicable. As there is no "training set" for an algorithm, this question is not relevant. The "ground truth" for the device's design and manufacturing is established through adherence to quality systems (e.g., ISO 13485), engineering principles, and regulatory requirements (e.g., 21 CFR Part 820 for good manufacturing practices), which guide the development and production of medical devices.

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