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The HemCon Bandage OTC is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Bandage OTC also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.

The HemCon Bandage PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.

Hem Con ChitoFlex PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.

The HemCon Patch PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.

The HemCon Strip First Aid PRO is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Strip First Aid PRO also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.

The HemCon Strip PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.

The HemCon® Bandage family of products are lyophilized (freeze dried) chitosan based dressings designed to optimize the muco adhesive surface density and structural integrity of chitosan at the site of injury. The bandages are soft, pliable, off-white, non-woven, lamellar dressings composed of a non-mammalian biocompatible, hydrophilic cellulose polymer, poly-N-acetylglucosamine (NAG), isolated from arctic shrimp "Pandalus Borealis' chitosan.

When applied directly to a wound the dressing controls bleeding. The chitosan dressings offer an antibacterial barrier against a wide range of gram positive and gram negative organisms including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.

The HemCon Bandage Family of products may be manufactured to any size and are currently available in sizes: 1.5" x 1.5", 1" x 4", 2" x 2", 2"x 4", 4"x 4",3" x 9″ and 3" x 28".

The HemCon Bandage family products are safe, durable, highly effective, and do not contain human proteins or clotting factors.

Here's a summary of the acceptance criteria and study information for the HemCon® Bandage family of products, based on the provided text:

Acceptance Criteria and Reported Device Performance

Although specific numerical acceptance criteria (e.g., "hemostasis achieved in X% of cases") are not explicitly stated as strict pass/fail thresholds in the provided text, the studies aimed to demonstrate the device's ability to achieve hemostasis in specific scenarios and provide an antibacterial barrier. The reported performance below reflects the positive outcomes that led to the substantial equivalence determination.

Study Details:

1. Sample sizes used for the test set and data provenance:

   • Antibacterial Testing: Specific sample size for each organism strain not specified, but multiple single strains of various gram-positive and gram-negative organisms were tested. Data provenance is not explicitly stated but implies laboratory testing.
   • Animal Studies: 9 heparinized sheep (retrospective/prospective not specified, but implied prospective for testing purposes).
   • Clinical Study 1 (Epistaxis): 20 human subjects on anticoagulant therapy (interventional, prospective).
   • Clinical Study 2 (Catheterization): 70 subjects treated with HemCon, 66 subjects treated with control (interventional, randomized open-label, prospective).

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • The document does not mention the use of experts to establish ground truth for the test sets in the traditional sense of consensus reading for image analysis or similar tasks.
   • For the animal and clinical studies, ground truth (hemostasis, rebleeding, adverse events) was established by direct observation and clinical assessment by the study investigators.

3. Adjudication method for the test set:

   • Not applicable as the studies described do not involve expert adjudication of results in the way typically seen for diagnostic device studies (e.g., image interpretation). Clinical outcomes were directly observed and recorded.

4. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. The studies focused on device performance against a control/standard of care, not on improving human reader performance with AI assistance.

5. Standalone (algorithm-only) performance:

   • Yes, the studies describe the standalone performance of the HemCon devices. These are material-based medical devices, not AI algorithms. Their performance was evaluated directly without human-in-the-loop assistance in the context of interpretation, but rather in their direct application to wounds.

6. Type of ground truth used:

   • Biocompatibility: In-vitro (cytotoxicity, sensitization, irritation) and in-vivo (systemic toxicity, implantation) biological reactions, following international and USP standards.
   • Antibacterial Barrier: Laboratory testing results of log reduction values against specific bacterial strains.
   • Animal Studies: Direct observation and angiography to confirm hemostasis in sheep.
   • Clinical Studies: Direct clinical observation by physicians (cessation of bleeding, rebleeding, adverse events) as defined by study protocols.

7. Sample size for the training set:

   • Not applicable. These are material-based medical devices, not AI/ML algorithms that require training sets.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set was used.

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