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The MicroTract Access System is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23cm in overall length.

The MicroTract Access System contains a 20 gauge Access Needle, a 0.018" Guidewire, and a Dilator Adapter. The Dilator Adapter is a sterile, single use device that is hollow and has a tapered increase in outer diameter on one end. This shape allows the Adapter to fill the excess space between .018" guidewires and dilators with larger inner diameters.

The provided text is a 510(k) summary for the MicroTract Access System, a medical device. It describes the device, its indications for use, and a summary of performance data used to demonstrate substantial equivalence to predicate devices.

However, the document does not contain the level of detail requested regarding specific acceptance criteria, study methodologies (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or outcomes of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

The "Performance Data" section in the summary is very high-level and states: "The MicroTract Access System was subjected to tensile testing to demonstrate that it met ISO11070-1998 specifications for dilators. The System also underwent testing for dimensional specifications, design verification and validation including insertion forces and useability as assessed on a simulated clinical bench model."

This statement confirms that some performance testing was conducted, but it doesn't provide the detailed acceptance criteria or study results in the format requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, ground truth establishment, expert involvement, or MRMC studies for this device based on the information provided. The document focuses on demonstrating substantial equivalence through general performance testing rather than a detailed AI-related study or clinical trial.

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