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CELOX Antibacterial Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.

CELOX Antibacterial Trauma Gauze may be used for the management of partial and full thickness wounds 1st and 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology and pressure ulcers/sores (partial and full thickness), surgical wounds and donor sites.

CELOX Antibacterial Trauma Gauze (Silver containing Antibacterial Dressing) is a soft, sterile, non-woven gauze dressing. This dressing is composed of Chitosan, Chitosan derivatives and structural woven gauze materials with the addition of Ionic Silver. The silver ions present in the dressing help to inhibit bacterial growth in the dressing. The dressing absorbs high amounts of wound fluid and bacteria, conforms to the wound surface, maintains a moist and creates a soft, cohesive gel that aids in the removal of non-viable tissue (autolytic debridement). The moist wound healing environment and the ability to inhibit bacterial growth in the dressing provided by the CELOX Antibacterial Gauze support the body's healing process.

This document is a 510(k) summary for the CELOX Antibacterial Trauma Gauze. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted directly from this document.

The document primarily states that the device is substantially equivalent to a predicate device (AQUANOVA Ag K100693 and CELOX Trauma Gauze K0917953) because it shares similar raw materials, manufacturing route, intended use, indications, product design, composition, and processing. The main difference highlighted is the addition of ionic silver as an antibacterial agent.

It also mentions that the product was "evaluated through standard biocompatibility tests (ISO 10993) and antimicrobial testing with appropriate organisms." However, it does not provide the specific acceptance criteria for these tests or the detailed results of the evaluations.

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