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DuoDERM Hydroactive Dressing is indicated for use on chronic wounds such as pressure ulcers, diabetic ulcers and acute wounds such as surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM Hydroactive Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue.

The concept of DuoDERM Hydroactive Dressing is not significantly different from other commercially available absorbent dressings intended to cover exudating wounds.

The provided text describes a 510(k) Premarket Notification for DuoDERM® Hydroactive® Dressing. It focuses on establishing substantial equivalence to another marketed device and expanding claims for moist wound healing and diabetic ulcers, while removing references to third-degree burns.

However, the document does not contain information about acceptance criteria, a specific study proving device performance against such criteria, or details regarding sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The text primarily outlines:

• Intended Use: For chronic wounds (pressure ulcers, leg ulcers, diabetic ulcers) and acute wounds (surgical, traumatic, first and second-degree burns, dermatological excisions).
• Substantial Equivalence: Claimed to ConvaTec's SignaDRESS Hydrocolloid Dressing, based on equivalent intended use and dressing characteristics.
• Safety Data: References "Data/information supporting the safety of DuoDERM Hydroactive Dressing was presented in Premarket Notifications K821656. All testing was performed in accordance with Good Laboratory Practices Regulations." However, the details of K821656 are not provided in this document.
• Contraindications: Known sensitivity to the dressing or its components.
• FDA Response: The FDA determined the device is substantially equivalent but placed limitations on labeling claims (e.g., no labeling for third-degree burns, no claims of accelerating healing, no claims of long-term/permanent dressings, no claims of treatment/cure for wounds).

Therefore, I cannot provide the requested information in the format of acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or MRMC/standalone study results because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence rather than a detailed report of a clinical performance study with specific acceptance criteria.

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