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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 working length sizes 110cm, 130cm, 150cm, 165cm and 175cm 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.

This document is a 510(k) premarket notification for the Maestro Microcatheter and primarily focuses on demonstrating substantial equivalence to a predicate device. It describes performance testing conducted to support this claim, but it does not detail a study involving AI or human readers, or provide specific acceptance criteria and reported device performance in the manner typically seen for AI/CADe devices.

Therefore, many of the requested sections about AI/CADe study design cannot be answered from the provided text.

Here is the information that can be extracted or inferred from the document regarding acceptance criteria and performance, as appropriate for a medical device cleared via 510(k) demonstrating equivalence:

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

The document does not explicitly present a table of acceptance criteria alongside reported performance for each specific test in numerical detail as would be expected for an AI system's metrics (e.g., sensitivity, specificity, AUC). Instead, it broadly states that the conducted tests met "predetermined acceptance criteria."

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes bench and design validation testing, not a clinical study involving a "test set" of patient data. Therefore, the concepts of sample size for a test set, data provenance, and retrospective/prospective do not apply in the context of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as this is bench and design validation testing for a physical medical device, not a diagnostic AI system requiring expert-established ground truth.

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

Not applicable for the reason stated above.

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 submission is for a microcatheter, not an AI or CADe device. No MRMC study was conducted.

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

Not applicable. This is not an algorithm or AI device.

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

For the bench and design validation tests, the "ground truth" implicitly refers to physical measurements, engineering specifications, and established limits defined by relevant standards (e.g., ISO 10555-1) and internal product requirements. The tests assessed characteristics like effective length, tensile force, leakage, pushability, trackability, etc., against predefined pass/fail criteria.

8. The sample size for the training set

Not applicable. No training set is involved for this type of device submission.

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

Not applicable. No training set is involved.

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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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