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Avogel® is intended for use in the management of hypertrophic scars.

Avogel® is a sheet of hydrogel with a polyurethane film backing.

Here's an analysis of the provided text regarding the Avocet device (Avogel® Hydrogel Dressing) and its acceptance criteria, structured according to your request:

Based on the provided document (K981353 510(k) Summary), the Avogel® Hydrogel Dressing is a Class I medical device that received clearance through the 510(k) pathway by demonstrating substantial equivalence to previously marketed predicate devices. This means the primary "acceptance criterion" for this type of submission is not a specific performance metric against a numerical threshold, but rather the demonstration that the new device is as safe and effective as existing legally marketed devices for the same intended use.

Therefore, the "study that proves the device meets the acceptance criteria" is the submission of evidence demonstrating this substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a Class I device based on substantial equivalence, the "acceptance criteria" are qualitative declarations of similarity to predicate devices, and the "reported device performance" is a comparative statement.

| Acceptance Criterion (Implicit) | Reported Device Performance |
| :-------------------------------------------------------------

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