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Collatek is indicated for dry, light and moderately exudating partial and full thickness wounds such as:

• First and second degree burns
• Severe sunburns
• Superficial injuries, cuts, abrasions and surgical wounds

Collatek Hydrogel may be used under clinical guidance in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:

• Pressure (stage I-IV) and venous stasis ulcers
• Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• Donor sites and grafts

Collatek Hydrogel is a sterile wound-dressing from polyacrylic acid and collagen. The dressing encourages healing by maintaining a moist environment at the wound site in the case of dry of lightly exudating wounds. The collagen used in the dressing is from animals born, raised and slaughtered in the USA.

The provided text is a 510(k) summary for the Collatek Hydrogel wound dressing. It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, materials, safety, sterility, and packaging. This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered medical device.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or AI-specific studies (MRMC, standalone performance) because the document describes a traditional medical device (wound dressing) and not an AI/ML device.

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