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The Micro Catheter is intended for selective delivery of therapeutic devices and infusion of contrast media into the peripheral and neuro vasculature.

The proposed device Micro Catheter is a single-lumen catheter designed to be introduced over a steerable guidewire into the peripheral and neuro vasculature. The proximal end of the catheter incorporates standard Luer adapter to facilitate the attachment of accessories. The outer surface of the catheter has a lubricious coating at the distal end of the Micro Catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The device is intended for single use and is provided sterile.

The provided document is a 510(k) Pre-market Notification for a medical device called "Micro Catheter". It details non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

However, the document does not contain any information about a study proving the device meets acceptance criteria related to an AI/Machine Learning model, nor does it discuss human reader performance, AI assistance, or the establishment of ground truth for such models. The document focuses on the physical and biological performance of a catheter device through standard engineering and biocompatibility tests.

Therefore, I cannot fulfill your request for the following sections as the information is not present in the provided text:

• A table of acceptance criteria and the reported device performance: The document provides a table of test methods and results for non-clinical performance and biocompatibility, but these are for the physical device, not an AI model.
• Sample sized used for the test set and the data provenance: Not applicable as no AI/ML model testing is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document pertains to the regulatory clearance of a physical medical device (a micro catheter) and its performance is evaluated through standard engineering and biological compatibility tests, not through the evaluation of an AI or machine learning algorithm.

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