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Collexa may be used for the management of wounds such as:

• Diabetic ulcers
• · Venous ulcers
• . Pressure ulcers
• Ulcers caused by mixed vascular etiologies .
• Full-thickness & partial thickness wounds .
• Abrasions .
• Traumatic wounds .
• 1st and 2nd degree burns .
• Dehisced surgical wounds .
• Exuding wounds .

Collexa is a collagen matrix sponge with a polyurethane foam backing intended for topical use on wounds as described in the intended use section of this 510(k) summary. The polyurethane foam is absorbent and acts as a reservoir for wound exudates. The product is supplied sterile for single use only.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study conducted to prove the device meets acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

The document is a 510(k) summary for a medical device called Collexa, a topical wound dressing. It primarily focuses on demonstrating substantial equivalence to predicate devices and includes information about the device's intended use, description, and biocompatibility. While it mentions that "Biocompatibility testing has confirmed that Collexa meets all the biocompatibility testing requirements in accordance with ISO 10993-1:2009," it does not provide details of this testing or present specific acceptance criteria or performance results in the format you requested.

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