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The Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.

The Maestro Microcatheter is available in 2.8F (proximal) / 2.1F (distal) size and 110cm, 130cm and 150cm lengths. The distal tip of the microcatheter is offered in straight or pre-shaped 45 degree and swan neck configurations. The proximal end of the catheter consists of a molded winged hub with a tapered strain relief. The outer surface of the distal 80cm of the microcatheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the catheter into the vasculature. The microcatheter incorporates a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The Maestro Microcatheter is offered with two 3ml syringes.

The provided text is a 510(k) premarket notification for a medical device (Maestro Microcatheter) and does not contain information about a study proving the device meets acceptance criteria related to an AI/algorithm-driven medical device.

Instead, it describes the bench testing performed for a physical medical catheter to demonstrate its substantial equivalence to a predicate device. The tests are focused on the physical and mechanical properties of the catheter, not on the performance of a diagnostic algorithm or AI system.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance of an AI/algorithm device based on the given text. The text does not mention:

• A table of acceptance criteria and reported device performance for an AI/algorithm.
• Sample sizes for a test set or data provenance for an AI/algorithm's performance.
• Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
• Adjudication methods for an AI/algorithm's test set.
• MRMC studies or effect sizes for human readers with and without AI assistance.
• Standalone performance data for an algorithm.
• Types of ground truth (expert consensus, pathology, outcomes data) relevant to an AI/algorithm.
• Sample size for a training set for an AI/algorithm.
• How ground truth for a training set was established for an AI/algorithm.

The document lists "Performance Testing-Bench" and "Design Validation" categories with specific physical tests (e.g., Tensile Force, Flow Rate, Kink Resistance, Trackability, Pushability). The conclusion drawn is that "The results of the testing demonstrated that the subject 2.8F/2.1F Maestro Microcatheter met the predetermined acceptance criteria applicable to the safety and efficacy of the device. This has demonstrated the subject is substantially equivalent to the predicate device." However, the specific acceptance criteria values for each of these physical tests are not detailed in the provided summary.

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