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PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint are 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™ and PosiSep™ X are indicated for use as a nasal hemostat to treat epistaxis.

PosiSep" and PosiSep" X are intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint are sterile hemostats comprised of modified Chitosan particles and polysaccharide binders. Chitosan has well known hemostasis properties and, when combined with carboxymethylcellulose and hydroxyethylcellulose binders, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep" and PosiSep" X Hemostat Dressing/Intranasal Splint have the material composition as the currently market cleared Hemostasis PosiSep™ and PosiSep Topical Hemostat. The PosiSep " and PosiSep" X Hemostat Dressing /Intranasal Splint are used for topical wounds and placed in the nasal cavity after surgery or trauma for the treatment of bleeding and as a space occupying stent to separate sinus tissue and prevent adhesions between mucosal surfaces. The dressings quickly dehydrate blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.

PosiSep™ and PosiSep™X are removed from the sight of application by natural excretion and routine flushing to eliminate the material from the nasal cavity and avoid the issues involved with physical removal of a non-fragmenting dressing.

I cannot provide a table of acceptance criteria and reported device performance from the provided text, as the document is a 510(k) summary for a medical device (PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint) and does not contain specific acceptance criteria or detailed performance data in a measurable format.

The document primarily focuses on establishing substantial equivalence to predicate devices for FDA clearance. It mentions "Design verification testing was performed... to demonstrate physical and functional requirements were met" and "Animal and bench testing demonstrated appropriate hemostatic and tissue separation properties," but it does not quantify these requirements or the specific results against numerical acceptance criteria.

Also, the document does not describe a study involving an algorithm or human-in-the-loop performance, as this device is a physical medical dressing/splint, not an AI or digital health device. Therefore, questions related to test sets, ground truth, expert opinions, MRMC studies, or training sets are not applicable to this submission.

Here's an overview of the information that can be extracted from the document:

• Type of Device: Hemostat Dressing/Intranasal Splint (physical medical device).
• Purpose: To control minimal bleeding, separate tissues, prevent adhesions, and aid healing after nasal/sinus surgery or for epistaxis.
• Key components: Modified Chitosan particles and polysaccharide binders.
• Study Types mentioned (but not detailed with acceptance criteria or results):
  • Biocompatibility testing (ISO 10993 and FDA guidance)
  • Sterilization validation (gamma radiation to SAL of 10^-6)
  • Performance Bench Testing (for physical and functional requirements)
  • Animal testing (for hemostatic and tissue separation properties)

Without specific numerical data, I cannot populate the table or answer questions about metrics like sample sizes for test/training sets, adjudication methods, or expert qualifications, as these are not present in the provided 510(k) summary for this type of device.

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