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The Polylin with Wings infusion set is intended for use as an influsion administration set for delivery of appropriately labeled fluids or solutions from an external infuston purpo or syringe.

This infusion sol is intended for the subculareous administration of medicine, Including from a portable, external purno to a subsble influsion site. The infusion set is designed to be used in conjunction with a Minitod infusion pump, but may be used in other puntus capable of supporting a Lucr connection to a reservoir, however, care must be exercised by the prescriber and user to ensure delivery accuracy if used with other dovices.

Device materials have been successfully tested for biocompairbility. All components liaving contact with solutions being administered most the ISO 10993 standard for medical devices of this (ype.

This document is a 510(k) summary for a medical device (Polyfin® with Wings Infusion Set). It focuses on demonstrating substantial equivalence to a predicate device and does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would typically be found in a clinical trial report or a performance study summary for an AI/ML-driven device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the format you've provided, as this document does not contain that specific type of data.

Here's why and what kind of document would typically have this information:

• Acceptance Criteria & Performance Studies: These are common in submissions for devices that incorporate more complex algorithms, AI/ML, or those requiring clinical performance validation beyond substantial equivalence to a predicate device with minor design changes.
• This Document's Purpose: This 510(k) summary is for a mechanical infusion set. The primary goal is to show that the "new device introduces no new technological features" and that adding wings (for easier insertion and stability) and modifying the needle guard are non-significant changes that "raise no new issues of safety or effectiveness" when compared to the predicate device.
• Safety and Effectiveness in this Context: For this type of device, safety and effectiveness are primarily demonstrated through biocompatibility testing (mentioned as successfully completed under ISO 10993) and comparison to a legally marketed predicate device, rather than a clinical performance study with specific outcome metrics against acceptance criteria.

To answer your request directly based on the provided text, I can state:

1. A table of acceptance criteria and the reported device performance: Not available in this document. The document states "Device materials have been successfully tested for biocompairbility" and "All components having contact with solutions being administered meet the ISO 10993 standard for medical devices of this type." This reflects a very high-level "acceptance," but not specific performance metrics against defined criteria.
2. Sample sized used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned as it's not applicable to a mechanical infusion set.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an algorithm-driven device.
7. The type of ground truth used: Not applicable in the context of an AI/ML algorithm. The "ground truth" for this device's safety is its successful biocompatibility testing and substantial equivalence to a predicate device.
8. The sample size for the training set: Not applicable; there is no "training set" for this mechanical device.
9. How the ground truth for the training set was established: Not applicable.

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