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Rx Indication: Under professional medical care, SURECELL Gelling Fiber Wound Dressing may be used for the management of: Leg ulcers (Stage I-IV), Diabetic ulcers, Surgical wounds (e.g. post-operative, donor sites, dermatological), Pressure ulcers, Burns (1st and 2nd degree), and Surgical or traumatic wounds which have been left to heal by secondary intention. SURECELL Gelling Fiber Wound Dressing maintains a moist wound environment. SURECELL Gelling Fiber Wound Dressing may also be used for the local management of wounds such as wounds that have been surgically or mechanically debrided, donor sites, and traumatic wounds.

OTC Indication: SURECELL Gelling Fiber Wound Dressing Over-the-Counter is indicated for minor Burns, minor abrasions and minor Lacerations, minor superficial cuts. SURECELL Gelling Fiber Wound Dressing is intended for the maintenance of a moist wound environment.

SURECELL™ Gelling Fiber Wound Dressing is a sterile non-woven wound dressing composed of hydrophilic fiber (a mixture of chitosan and chitosan derivatives). This soft and highly absorbent dressing vertically absorbs wound exudate and creates a comfortable clear gel to maintain a moist environment for optimal wound healing.

This is a medical device 510(k) summary for a wound dressing, not an AI/ML device. Therefore, the requested information about acceptance criteria, study design, ground truth, and expert involvement for an AI/ML device is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the SURECELL Gelling Fiber Wound Dressing to a predicate device (MedTrade Products AQUANOVA Super-Absorbent Dressing) based on similar intended use, design, mechanisms of action, technology, and materials. It outlines various performance tests conducted for this wound dressing, but these are standard tests for physical and biological properties of a medical device, not related to the performance of an AI algorithm.

Specifically, the "Performance Data" section mentions:

• Bench testing: absorbency, gelling characteristics, pH, loss on drying, residue on ignition, heavy metals, bacterial endotoxins, breaking strength, packaging sealing, and sterility.
• Biocompatibility testing: cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute toxicity, implantation.
• Sterilization validation testing.
• Shelf life stability testing.

These are typical tests for a physical medical device and do not involve AI/ML performance metrics, ground truth establishment by experts, or sample sizes for AI training/test sets.

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