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For the management of oral wounds and sores, including:

• Denture sores
• Oral ulcers (non-infected or viral)
• Oral dicorp (surgical wounds)
• Suture sites
• Burns
• Extraction sites
• Surgical wounds
• Traumatic wounds

Not Found

The provided text is a letter from the FDA regarding a medical device, Hycure Oral/Hycure Oral Smart Gel, and discusses its regulatory classification, labeling limitations, and substantial equivalence.

It does not contain any information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert involvement for a medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

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(for the indications for use stated in the enclosure)

Not Found

This document is a marketing clearance letter from the FDA for the HYCURE™ device, a wound dressing. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices and outlines limitations on labeling claims.

Ask a specific question about this device