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The Micro Catheter and Guidewire System is intended for the infusion of contrast media into the peripheral vasculature. The Micro Catheter and Guidewire system is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis.

Micro Catheter and Guidewire System consists of a catheter, a guidewire, and accessories. The accessories include a flushing device, a shaping mandrel, an insertion tool, and a torque device. The catheter is consist of a hub, a stress relief tube and a catheter body. The catheter body has three layers. The inner layer is a PTFE tube, the middle layer is consist of stainless steel wire reinforce and platinum-iridium alloy radiopaque distal marker, and the outer layer is polyamides of different hardness mixed with pigment. There is also a hydrophilic coating on the catheter surface. The guidewire is consist of a nitinol core, a polymer jacket with hydrophilic coating over its entire surface and a radiopaque distal marker. It has a white marker at the proximal end to indicate the length inserted into human body and its relative position with the catheter.

The provided text is a 510(k) premarket notification for a medical device (Micro Catheter and Guidewire System). This type of document is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets a specific set of quantitative acceptance criteria through a clinical study or a study directly measuring performance against predetermined thresholds for an AI/software as a medical device.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design for AI/software, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details is not present in this document. This document details the physical characteristics, intended use, and bench testing for a physical medical device.

Here's why the information is not here, and what type of information is provided:

• Acceptance Criteria & Reported Device Performance (Table 1): The document does not provide a table of quantitative acceptance criteria for performance in the way you'd expect for, say, an AI diagnostic tool (e.g., "sensitivity > 90%"). Instead, it lists various bench tests conducted (e.g., Catheter Sizes, Coating Integrity, Peak tensile force, etc.) and states that "The data provided demonstrate that the Micro Catheter and Guidewire System is substantially equivalent to the predicate device." This implies the device passed these bench tests, but the specific numerical acceptance criteria and measured values are not detailed in this public summary.

• Sample size and data provenance for test set: Not applicable for this type of device and study. Bench testing is performed on physical samples.

• Number of experts and qualifications for ground truth: Not applicable. Ground truth for physical device bench testing is based on engineering specifications and direct measurement.

• Adjudication method: Not applicable.

• MRMC comparative effectiveness study: Not applicable. This is a physical device, not an AI or imaging diagnostic tool that assists human readers.

• Standalone performance: Not applicable in the context of AI performance. The document describes the standalone performance of the physical device through bench testing.

• Type of ground truth used: For this device, the "ground truth" is defined by engineering specifications, material properties, and physical testing standards (e.g., ISO 10555.1, ISO 11070).

• Sample size for training set & How ground truth for training set was established: Not applicable. This is not a machine learning/AI device.

What the document does provide in relation to "proving the device meets acceptance criteria":

The document focuses on demonstrating substantial equivalence to a predicate device, which is the primary regulatory pathway for 510(k) submissions. This is achieved by:

1. Indications for Use: Stating that the device has the same intended use as the predicate device (infusion of contrast media, drug infusion in intra-arterial therapy, infusion of embolic materials for hemostasis into peripheral vasculature).
2. Technological Characteristics: Highlighting similarities in design (catheter, guidewire, accessories, provided sterile, single use, hydrophilic coating, platinum-iridium alloy radiopaque marker).
3. Performance Data: Listing a comprehensive set of biocompatibility tests (e.g., Cytotoxicity, Sensitization, Hemolysis study) and bench tests (e.g., Catheter Sizes, Coating Integrity, Tensile force, Burst pressure, Guidewire Fracture test, Torque strength, Simulated use). These tests demonstrate that the device performs as intended and is safe, similar to the predicate. The implication is that the results of these tests met internal acceptance criteria to support the claim of substantial equivalence.

In summary, while the document indirectly "proves the device meets acceptance criteria" by stating its substantial equivalence based on safety and performance tests, it does not provide the detailed quantitative acceptance criteria and study particulars you've asked for, as those typically relate to AI/software performance rather than a physical medical device.

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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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