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The Polyfin extension set is intended for use as a fluid delivery set for medication from an external infusion pump.

The new device is a 42 inch or 60 inch length of Polyfin® with Luer connectors at each end. The device at the proximal end to a medication reservoir, such as the MiniMed reservoir, model 103, and at the distal end to an infusion set such as the Polyfin infusion set, model 106. The Polyfin extension set may also be used to administer drugs labeled for intravenous administration from an external pump by attaching the distal end to a "Y-site" or "Heparin lock."

This document is a 510(k) summary for a medical device (Polyfin Infusion Extension Set Model 128). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Information about sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any test or training set.
3. Details about MRMC comparative effectiveness studies or standalone algorithm performance.

The document is purely a regulatory submission describing a device and its perceived equivalence to a predicate device, focusing on statements about safety and effectiveness without providing the underlying study data you are asking for.

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