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The HemCon Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon Bandage also controls bleeding in patients following hemodialysis.

The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

HemCon ChitoFlex™ Surgical is intended for use as a dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.

It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries.

The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

The HemCon dressings are a hemostatic chitosan dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the dressing also controls bleeding in patients following hemodialysis.

The provided text is a 510(k) Substantial Equivalence Determination letter and associated documents for the HemCon Bandage, HemCon Bandage OTC, and ChitoFlex-Surgical devices. It does not include information about acceptance criteria or a specific study proving the device meets those criteria, as it's primarily focused on demonstrating substantial equivalence to predicate devices for expanded indications for use.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment from this document.

However, I can extract information related to the device's indications for use and the basis for its substantial equivalence. The document states:

"In vivo testing evaluated the efficacy of the Hemcon Bandage versus control to provide hemostasis in femoral artery catheter puncture sites. This data supports the effectiveness of the Hemcon Bandage in achieving hemostasis at percutaneous catheter sites."

This indicates that some in vivo testing was performed to support the effectiveness of the device for a specific new indication. However, it does not provide details on:

• Specific acceptance criteria used in that test.
• The exact study design (e.g., sample size, methodology, statistical analysis, full results).
• Details about the ground truth methods, experts, or training data for any AI component (as this is a medical device, not an AI/ML device in this context).
• Any multi-reader multi-case (MRMC) or standalone comparative effectiveness studies.

The document focuses on establishing substantial equivalence based on similar intended use, indications, and the fact that the majority of predicate devices are chitosan-based dressings. It lists several predicate devices, implying that their performance and safety data would have been considered during the initial clearance of those devices and serve as a basis for comparison.

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