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The Marathon™ Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

The Marathon™ Flow Directed Micro Catheters are single-lumen, endhole catheters designed for the sub selective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. Microcatheter may be used with stylet, guidewire or introducer sheath to increase the rigidity of the distal section during introduction into the guiding catheter.

The provided text describes a 510(k) premarket notification for a medical device, the Marathon™ Flow Directed Micro Catheter. The document focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and bench testing.

However, the provided text DOES NOT contain information regarding:

• AI/Algorithm performance: This document is for a physical medical device, not an AI or algorithmic diagnostic tool.
• Acceptance criteria for an AI model: The acceptance criteria listed are for physical characteristics and performance of a catheter.
• Sample size for a test set or training set for an AI model: No AI model is being evaluated.
• Data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance: These are all concepts relevant to the evaluation of AI/ML-based medical devices or diagnostic algorithms, which are not the subject of this document.
• Effect size of human reader improvement with AI assistance: Not applicable.
• Type of ground truth used (pathology, outcomes data, etc.): Not applicable in this context.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of an AI/ML model, nor can I answer the specific questions about AI model testing that were asked.

The document instead focuses on demonstrating the substantial equivalence of the Marathon™ Flow Directed Micro Catheter to a predicate device (K093750) through bench testing and biocompatibility assessments.

Here's the relevant information about the device's acceptance criteria and proven performance based on the provided text, re-framed to address the questions where applicable, but noting when the question is not relevant to this document.

1. A table of acceptance criteria and the reported device performance (for the physical device, not AI):

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

• This document is for a physical medical device and discusses bench testing, not an AI model's test set.
• Sample Size for Bench Testing:
  • Specific sample sizes for each bench test are not explicitly stated in this summary table, only the results. However, typical regulatory submissions for physical devices involve testing a statistically representative number of units.
• Data Provenance: Not applicable in the terms used for AI. The data originates from internal laboratory bench testing conducted by the manufacturer (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular).
• Retrospective/Prospective: Not applicable in this context. These are lab tests.

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 evaluated through engineering bench tests and biocompatibility testing, not through expert-labeled diagnostic data for an AI model.

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

• Not applicable. This is for a physical device, not an AI test set requiring human adjudication.

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 document is about a physical medical device (catheter), not an AI system that assists human readers. No MRMC study was conducted or is relevant.

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

• Not applicable. This is not an AI algorithm.

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

• For the biocompatibility tests, the "ground truth" is established by standard biological assays and the observation of cellular and blood responses against established safety thresholds.
• For the bench performance tests, the "ground truth" is the physical properties and performance characteristics of the catheter as measured against predefined engineering specifications and international standards (e.g., ISO 10555-1, ISO 80369). These are objective measurements.

8. The sample size for the training set:

• Not applicable. There is no AI model requiring a training set described here.

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

• Not applicable. There is no AI model or training set described here.

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The Marathon™ Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

The Marathon™ Micro Catheters are single-lumen, endhole catheters designed for the subselective infusion of physician specified therapeutic agents or contrast media in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. The stylet accompanying the catheter is used to increase the rigidity of the distal section during introduction into the guiding catheter.

This document is a 510(k) summary for the Marathon™ Flow Directed Micro Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove device performance against specific metrics. Therefore, several requested elements cannot be extracted directly from the provided text.

Here is the information that can be gleaned and a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document describes "in vitro and in vivo tests" that were performed, but it does not specify quantitative acceptance criteria (e.g., "Visualization must be X to Y" or "Biocompatibility must pass ISO 10993 XYZ levels"). Instead, it states that the device is "substantially equivalent" to predicate devices for various characteristics. This indicates that the performance was assessed against the predicates, but the exact acceptance thresholds are not provided.

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

• Sample Size: Not specified.
• Data Provenance: The document states "MTI performed in vitro and in vivo tests." This implies the testing was conducted by or for Micro Therapeutics, Inc. However, it does not specify the country of origin of any patient data (if applicable to "in vivo tests," which could also refer to animal studies) or whether the data was retrospective or prospective. Given the nature of a 510(k) for a micro catheter, "in vivo" could refer to animal models rather than human patient data for demonstrating substantial equivalence for engineering characteristics.

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

• This information is not provided. The 510(k) summary does not mention expert review or ground truth establishment in the context of device performance testing.

4. Adjudication Method for the Test Set

• This information is not provided. There is no mention of an adjudication process for any test results.

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

• No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (a micro catheter), not an AI algorithm.
• Therefore, there is no effect size related to human readers improving with AI assistance.

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

• No, this is not applicable. The device is a physical micro catheter, not an algorithm.

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

• This information is not explicitly stated in relation to the "in vitro and in vivo tests." The "ground truth" for a physical device like a catheter would typically be its measured physical properties (e.g., dimensions, force, flow rates) and biological compatibility, verified against established standards or predicate device performance.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, there is no "training set" for a physical medical device.

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