(220 days)
QuikClot is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
QuikClot is a bulk granular hemostatic agent, which is placed on or into a moderate to severe wound to effect adsorption, and coagulation of same.
QuikClot is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss.
The effect of QuikClot is purely physical, not chemical in nature. QuikClot has an unusually high adsorptive effect on liquid. This rapid adsorption of water as a blood component serves to concentrate platelets, and increase the speed and effect of their clotting capabilities. This rapid adsorption also diminishes the volume of the liquid present in the wound as a sponge effect, to facilitate clotting.
The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation.
Used in conjunction with a sterile bandage and pressurizing wrap, QuikClot will reduce blood loss dramatically, and significantly increase survivability of highvolume catastrophic wounds.
I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance, sample size for testing or training, expert involvement, adjudication methods, or MRMC studies.
The document is a 510(k) summary for a device called "QuikClot." It focuses on demonstrating substantial equivalence to a legally marketed predicate device (RDH Bandage) rather than detailing specific performance against acceptance criteria in the context of an AI/ML device.
Here's why the requested information cannot be extracted:
- Device Type: QuikClot is described as a "bulk granular hemostatic agent," which is a physical device, not an AI/ML device. The questions you've asked are highly specific to AI/ML device validation.
- Study Focus: The studies mentioned ("Invitro and Invivo testing on rats, rabbits and larger mammals," "biocompatibility testing") are geared towards demonstrating the hemostatic properties and safety of the physical product, not the performance of an algorithm.
- Regulatory Context: A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, meaning it's as safe and effective as a device already on the market. It doesn't typically require the type of detailed performance criteria and AI-specific studies you've inquired about.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, AI performance, expert review, or data origins.
N/A