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PosiSep " and PosiSep" X Hemostat Dressings are topical dressings for the temporary treatment of bleeding wounds such as surgical wounds (post operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. PosiSep"" and PosiSep"" X are intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep™ and PosiSep™X Hemostat Dressings are sterile hemostats comprised of modified Chitosan particles and polysaccharide binders. Chitosan has well known hemostasis properties and, when combined with carboxymethylcellulose and hydroxyethylcellylose binders, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep" and PosiSep™ X Hemostat Dressings have the identical material composition as the currently market cleared Hemostasis ExcelArrest Topical Hemostat. The PosiSep " and PosiSep " X Hemostat Dressings are used for topical wounds. The dressings quickly dehydrate blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.

The provided text describes the 510(k) summary for PosiSep™ and PosiSep™ X Hemostat Dressings. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. Instead, it relies on a "substantial equivalence" argument to predicate devices.

The available information regarding testing is general:

• Biocompatibility testing was performed using ISO 10993 and FDA guidance.
• Sterilization was validated using gamma radiation to assure a sterility assurance level (SAL) of 10⁻⁶.
• Performance Bench Testing was performed for PosiSep™ X Hemostat Dressings to demonstrate physical and functional requirements were met.

Since specific performance data and acceptance criteria are not explicitly detailed in the provided text, the response below will reflect the lack of this information.

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for PosiSep™ and PosiSep™ X Hemostat Dressings does not explicitly state specific acceptance criteria or report detailed device performance results in a manner that would typically be seen in a clinical or robust standalone performance study demonstrating adherence to pre-defined criteria.

Instead, the submission primarily relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "Conclusion" section states, "Through the data and information presented, Hemostasis, LLC considers the PosiSep™ and PosiSep™ X Hemostat Dressings substantially equivalent to the predicate devices already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design and functional performance and present no new concerns about safety and effectiveness."

Here's an breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria	Reported Device Performance
   Functionality	"Physical and functional requirements were met" (for PosiSep™ X Hemostat Dressings based on Performance Bench Testing). However, no specific metrics or thresholds are provided.
   Biocompatibility	"Pass the biocompatibility requirements for their intended use" based on ISO 10993 and FDA guidance. No specific test results or acceptance values are given.
   Sterility	Sterilized using a validated gamma radiation method to assure a sterility assurance level (SAL) of 10⁻⁶. This implies meeting the SAL requirement.
   Hemostatic Efficacy	No specific performance metrics (e.g., time to hemostasis, percentage of successful hemostasis) or acceptance criteria are reported in this document. The claim is based on being substantially equivalent to predicates known for hemostatic properties.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified for any of the mentioned tests (Biocompatibility, Sterilization, Performance Bench Testing).
   • Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable/Not specified. The provided document points to bench testing and biocompatibility assessments, not a study involving expert-established ground truth for performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable/Not specified. This is typically relevant for studies involving human interpretation or clinical endpoints, which are not detailed here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable. This device is a topical hemostat dressing, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This device is not an algorithm or AI system. Its performance evaluation would be through bench testing, in-vitro, or in-vivo (animal or human) studies. The document only vaguely mentions "Performance Bench Testing" for "physical and functional requirements."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not explicitly defined in the provided document for its performance claims. For biocompatibility, the "ground truth" would be the established acceptable limits for biological response as defined by ISO 10993. For sterilization, it's the demonstration of SAL 10⁻⁶. For hemostatic efficacy, the document does not provide details on how "ground truth" was established, relying instead on substantial equivalence.

8. The sample size for the training set

   • Not applicable. This device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

   • Not applicable. This device is not an AI/ML model that requires a training set.

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