(63 days)
HemCon ChitoFilex™ Surgical is intended for use as a topical 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 HemCon ChitoFlex™-Surgical Dressing is a sterile chitosan based dressing intended for use as a topical 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, donor sites, dermatalogical, etc.) and traumatic injuries.
I am sorry, but the provided text is a 510(k) premarket notification from the FDA regarding a medical device, the "HemCon ChitoFlex™ -Surgical Dressing". This document confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about:
- Acceptance criteria and reported device performance: The document confirms substantial equivalence but does not specify performance metrics or acceptance criteria for the device itself.
- Study details: There is no mention of any specific study conducted to prove the device meets acceptance criteria, including sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone studies, or the type of ground truth used.
- Training set details: No information about a training set, its sample size, or how its ground truth was established is provided.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided. The document is primarily an FDA clearance letter based on substantial equivalence to existing devices, not a detailed study report.
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