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Angiodynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
The intended use of the AngioDynamics Mariner Angiographic Catheters is to deliver radiopaque contrast media to the vasculature during angiographic procedures.

AngioDynamics Mariner Angiographic Catheters are sterile, single use, disposable devices designed to delivery radiopaque contrast media to selected sites in the vascular system. The AngioDynamics Mariner Angiographic Catheter is hydrophilicly coated at the distal end.

This document is a 510(k) premarket notification for a medical device called the "AngioDynamics Mariner Angiographic Catheter." It is focused on demonstrating substantial equivalence to an existing predicate device rather than presenting a study where acceptance criteria for device performance are evaluated against a specified performance range based on clinical outcomes or a standalone algorithm's accuracy.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of AI/ML or diagnostic performance (e.g., sensitivity, specificity, clinical endpoints), is largely not applicable to this document. The "performance data" referred to in Section I is primarily engineering and material testing to ensure the modified device functions safely and equivalently to its predecessor.

Here's a breakdown of why and what information can be extracted relative to the context of this document:

1. A table of acceptance criteria and the reported device performance:

This document does not present acceptance criteria in terms of clinical performance metrics like sensitivity or specificity. Instead, the "performance data" refers to non-clinical performance and material testing. The acceptance criteria for these tests would typically be specific engineering and material standards or internal company specifications, which are not detailed in this summary.

Explanation: The document states, "The proposed... and predicate... are substantially equivalent to the specified predicate devices based on a comparison of technological characteristics and the results of non-clinical performance and material testing, which include: Static Pressure, Tensile, Friction, Particulate, Biocompatibility per ISO 10993-1." This implies that the new device met the acceptance criteria (likely predefined engineering and material standards) for each of these tests, demonstrating substantial equivalence to the predicate. The specific numerical values or acceptance ranges are not provided in this summary.

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or image-based diagnostic study. The "test set" here refers to the physical units of the device subjected to non-clinical engineering and material tests. The specific number of catheters tested for each performance characteristic (Static Pressure, Tensile, etc.) is not detailed in this summary.
• Data Provenance: Not applicable. These are laboratory-based, non-clinical tests rather than data collected from patients or external sources.

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

• Number of Experts: Not applicable. Ground truth, in the context of clinical or diagnostic accuracy, is not established for these types of engineering performance tests. The "truth" for these tests is determined by standardized measurement protocols and instruments.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in expert opinions for ground truth establishment, which isn't part of these engineering tests.

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:

• MRMC Study: No. This document is for a physical medical device (angiographic catheter), not an AI/ML diagnostic algorithm. Therefore, an MRMC study is not relevant.
• Effect Size of Human Reader Improvement: Not applicable.

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

• Standalone Performance: No. This is a physical medical device and does not involve an algorithm.

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

• Type of Ground Truth: For the engineering and material tests, the "ground truth" is defined by the physical properties and performance specifications of the device, measured by calibrated equipment according to established test methods and standards (e.g., ISO 10993-1 for biocompatibility). There is no "expert consensus" or "pathology" ground truth in this context.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

In summary: This 510(k) submission describes physical performance and material testing for a catheter to demonstrate substantial equivalence to a predicate device, focusing on safety and function rather than diagnostic accuracy or AI/ML performance. Thus, many of the requested items related to clinical study design, expert ground truth, and AI validation are not relevant to the information provided in this document.

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