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PosiSep® X BAM Hemostat Dressing/Intranasal Splint is indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to:

• Separate tissue or structures compromised by surgical trauma;
• Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity;
• Help control minimal bleeding following surgery or trauma;
• Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and
• Act as an adjunct to aid in the natural healing process

PosiSep® X BAM is indicated for use as a nasal hemostat to treat epistaxis. PosiSep® X BAM is intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep® X BAM is placed in the nasal cavity after sinus surgery to prevent adhesions, control mild bleeding, and provide a level of protection against bacteria and fungi. PosiSep X BAM is supplied as a compressed foam, and it quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema. Upon hydration, PosiSep® X BAM expands to contact and conform to the surrounding anatomy.

PosiSep X BAM is comprised of N, O-Carboxymethyl Chitosan derived from non-shell fish based Chitosan, modified Cellulose, and antimicrobial agents.

PosiSep® X BAM is fragmentable and eliminated from the site of application by natural excretion through the action of cilia.

The provided text is a 510(k) summary for a medical device called PosiSep® X BAM Hemostatic Dressing/Intranasal Splint. It describes the device, its intended use, and how its substantial equivalence to a predicate device (Hydrofera Bacteriostatic Nasal Dressing) was demonstrated. However, this is NOT a study that evaluates an AI/ML powered device, nor does it contain acceptance criteria or study results for such a device.

The information you requested (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) are typically found in the clinical study report or performance evaluation section of an AI/ML device submission. This document does not contain any of that information.

The document describes performance bench testing for antimicrobial activity of the PosiSep® X BAM device, but this is a physical/chemical performance test of a traditional medical device, not an evaluation of an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot provide the requested information from the given text because it is not relevant to an AI/ML device.

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