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The Polyin OR with Wings infusion set is intended for use an influsion administration set for delivery of appropriately labeled finids or solutions from an external influsion punp or syringe.

This infusion set is intended for the subculancous administration of medicine, including insulin, from a portable external pump to a suitable infusion site. The infusion set is designed to be used in conjunction with a Minited infusion pump, but may be used in other purness capable of supporting a I her connection to a reservoir; however, care must be excreised by the prescriber and user to ensure dolivery accuracy if used with other devices. Device thaterials luve been successfully tested for biocompatibility. All components luxing contact with solutions being administered meet the ISO 10993 standard for modical devices of this type.

This document, K964456, describes a 510(k) summary for the "Polyfin QR® with Wings Infusion Set." It's important to note that this is a pre-market notification for a medical device, and the content provided is a summary for regulatory approval, not a detailed scientific study report.

Based on the provided text, it's not possible to extract the requested information regarding acceptance criteria and a study proving those criteria were met in the way one would for a diagnostic AI device or a device requiring extensive clinical trials for performance claims. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through material biocompatibility and mechanical design changes.

Here's an attempt to address your questions based solely on the provided text, with significant limitations due to the nature of the document:

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

Limitations: The document does not provide quantifiable performance metrics (e.g., flow rates, leakage rates, or specific clinical outcomes) or explicit numerical acceptance criteria beyond meeting a standard (ISO 10993) and asserting no new safety/effectiveness issues.

Regarding the "study that proves the device meets the acceptance criteria":

The document does not describe a traditional "study" in the sense of a clinical trial or a performance study with a test set of human subjects or expert readers, as would be common for diagnostic or AI devices. Instead, the "proof" is based on:

• Biocompatibility testing: Mentioned implicitly as "successfully tested" against ISO 10993. No details on the type of test, sample size, or specific results are provided.
• Comparison to a predicate device: The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device. The changes (addition of wings) are deemed not to raise new issues of safety or effectiveness, implying that the performance assumed safe and effective for the predicate device holds for the new device.

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

• Sample Size: Not applicable/Not provided. There is no mention of a "test set" in the context of clinical data or performance evaluation of statistical significance. The "testing" referred to is for biocompatibility of materials.
• Data Provenance: Not applicable/Not provided.

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)

• Not applicable. This device is an infusion set, not a diagnostic tool requiring expert interpretation for ground truth establishment.

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

• Not applicable. There's no "test set" and no expert review process described.

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. This device is not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a mechanical infusion set, not an algorithm.

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

• Not applicable for a "ground truth" as you'd define it for a diagnostic study. The "truth" here is compliance with safety standards and functional equivalence to a predicate device, demonstrated through material testing and design comparison.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable.

In summary: K964456 is a 510(k) pre-market notification that relies on demonstrating substantial equivalence and compliance with material safety standards for an infusion set. It does not contain the kind of detailed performance study data, expert evaluations, or AI-related metrics that would be found in submissions for diagnostic or AI-powered devices. The "proof" here is primarily through material testing and a comparison to a previously approved device, with the assumption that minor physical changes do not alter fundamental safety or effectiveness.

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