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The catheter is intended to be used for the controlled selective infusion of physician specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy.

The Flow Rider Flow Directed Micro Catheter is a single lumen infusion catheter designed to be flow directed into the distal vasculature. The Flow Directed Micro Catheter has a hydrophilic coating to provide lubricity for navigation of vessels. A standard luer lock adapter on the proximal hub is used for the attachment of accessories. The catheter tip is indicated by a radiopaque marker to facilitate fluoroscopic visualization.

The provided text describes the 510(k) Summary of Safety and Effectiveness for the Flow Rider™ Flow Directed Micro Catheter. This is a medical device submission, and the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence to predicate devices, rather than a clinical trial proving specific performance metrics against a predefined threshold. Therefore, the information requested will be framed within the context of regulatory approval for a medical device.

Here's the breakdown of the information requested:

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

For a 510(k) submission, "acceptance criteria" are not typically presented as quantitative thresholds for clinical performance but rather as successful completion of various tests demonstrating the device's safety, effectiveness, and substantial equivalence to predicate devices. The "reported device performance" refers to the successful outcomes of these tests.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each physical test (e.g., how many catheters were burst tested or torqued). For the animal studies, the number of animals used or the number of procedures performed is not explicitly stated.
• Data Provenance: The document does not specify the country of origin for the testing data. Given the submitting company (Micro Therapeutics, Inc.) is based in San Clemente, CA, USA, it's highly probable the testing was conducted in the USA. The studies mentioned (biocompatibility, physical, animal) are prospective in nature, as they are performed specifically to evaluate the new device.

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)

This type of information is not applicable to a 510(k) submission for a catheter based on the provided text. The "ground truth" for this device is established through objective engineering tests (physical properties), standardized biocompatibility assays, and in vivo animal studies demonstrating functional equivalence to existing devices. There is no mention of human expert evaluation or consensus for establishing "ground truth" for the performance characteristics reported.

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

Not applicable. This device's evaluation relies on objective measurements and observations in laboratory and animal settings, rather than human review with an adjudication process.

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. The Flow Rider™ Flow Directed Micro Catheter is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of AI assistance is irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" in this context is established through:

• Engineering specifications and standards: For dimensional inspection, tensile strength, burst pressure, flow rate, and torque.
• Standardized biological assays: For biocompatibility testing (ISO 10993-1:1992(E)).
• Physiological and functional observations during animal studies: To demonstrate the catheter's ability to be flow-directed, infuse agents, and navigate vasculature, in comparison to predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

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