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The D-Stat® Dry Wrap hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The D-Stat® Dry Wrap Hemostatic Bandage consists of a lyophilized pad containing bovinederived thrombin as an aid to hemostasis (King Pharmaceuticals license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. The sterile device is sold in a foil pouch and is ready to use. The end user removes the D-Stat Dry Wrap from the pouch and applies the device to the bleeding site. Included is a transparent sterile bandage attached to the primary packaging to apply over the hemostatic pad. The pad has a slit approximately half the length of the pad to allow for the wrapping of the pad around vascular access catheters, like PICC (peripherally inserted central catheter) lines.

The D-State Dry Wrap is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical carrier to bleeding.

I apologize, but the provided text from the FDA 510(k) notification for the D-Stat® Dry Wrap Hemostatic Bandage does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a Substantial Equivalence (SE) determination letter, which means the FDA has reviewed the device and determined it is "substantially equivalent" to legally marketed predicate devices. This determination is primarily based on comparing the new device's indications for use and technological characteristics to those of existing, approved devices.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on this document.

The document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." (Page 1)
• "The D-State Dry Wrap is substantially equivalent to the currently marketed Thrombix™ Patch Thrombin Hemostasis Patch and D-Stat® Dry Clear Hemostatic Bandage products based on a comparison of the indications for use and technological characteristics of the device." (Page 4, Conclusion 6)

This type of FDA letter does not typically include detailed performance study results or acceptance criteria that would be found in a full clinical trial report or a performance validation study.

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