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For Over-the-Counter Use: SilverSeal Hydrogel Wound Dressing made with X-Static is indicated for the topical management of minor superficial wounds, minor lacerations, minor abrasions and minor first degree burns.

Hydrogel Wound Dressings with X-Static are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. Hydrogel Wound Dressings with X-Static are made of flexible sterile nonadherent hydrogel consisting of water and polymer with nylon fibers coated with metallic silver suspended in the hydrogel.

The provided document is a 510(k) summary for the SilverSeal® Hydrogel Wound Dressing, a medical device. It does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm-based medical device.

The document states:
"Hydrogel Wound Dressing with X-Static is the same product that was cleared in K040019 as the X-Static SilverSeal Hydrogel Wound Dressing. Therefore, the performance data provided in K040019 (section 6.2 pages 12-13 of K040019) is applicable to the 510(k) and no new performance data is provided."

This means that the current submission (K171041) relies on the performance data of a previously cleared device (K040019) and does not include any new studies or performance data. Furthermore, the device is a wound dressing, not an AI or algorithm-based device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment, as these concepts are not applicable to the type of device and submission described in the provided text.

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