(268 days)
Hemoblock S (Prescription): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations
Hemoblock S (OTC): To control bleeding of minor lacerations, minor cuts and minor abrasions
The Hemoblock_S (Hemoblock_S (Prescription Use) and Hemoblock_S (OTC Use)) for being placed on the U.S.A Market is single use, hemostatic dressing made of Chitosan and Cotton. This device is called to Hemoblock Gauze on the Republic of Korea Market.
Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Hemoblock_S acts as a mechanical barrier against bleeding by turning into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Hemoblock_S is provided in two different types to accommodate a variety of treatment regions, according to being based on the whether strap yan which is consisted with Nylon and handle for remove a device into any wound, with following;
- Gauze(N) Type: There is not strap yarn part on the Hemoblock_S
- Gauze(S) Type: There is strap yarn part on the Hemoblock_S
The Hemoblock_S is individually packaged in a foil pouch and is Irradiation sterilized in accordance with ISO 11137 Series.
The provided text does not contain information about the acceptance criteria and performance of a device based on a study; instead, it is a 510(k) premarket notification summary for a hemostatic dressing called "Hemoblock S". The document details the device's characteristics, its comparison to a predicate device, and non-clinical testing performed (biocompatibility, sterilization, shelf-life, and general performance tests like appearance, dimension, tensile strength, absorption, X-ray impermeableness, and in vitro blood clotting test). It also mentions an animal study for hemostatic testing.
There is no mention of a study involving a test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or specific acceptance criteria with reported device performance in the context of diagnostic accuracy or AI assistance. The performance tests mentioned are related to the physical properties and sterilization of the dressing, not its diagnostic or assistive capabilities for human readers.
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information regarding acceptance criteria and study results for device performance in the context of the questions asked.
N/A