(30 days)
NeuraWrap™ Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
NeuraWrap™ nerve protector is an absorbable collagen implant that provides a nonconstricting encasement for injured peripheral nerves for protection of the neural environment. NeuraWrap is designed to be an interface between the nerve and the surrounding tissue. When hydrated, NeuraWrap is an easy to handle, soft, pliable, nonfriable, porous collagen conduit. The wall of the conduit has a longitudinal slit that allows NeuraWrap to be spread open for easy placement over the injured nerve. The resilience of the collagen conduit allows NeuraWrap to recover and maintain closure once the device is placed around the nerve. NeuraWrap is provided sterile, non-pyrogenic, for single use only, in double peel packages in a variety of sizes.
The provided text for the NeuraWrap™ Nerve Protector does not describe a study involving an AI/Machine Learning device. Therefore, it's not possible to generate the requested information based on your input.
The document details a 510(k) submission for a physical medical device (an absorbable collagen implant) and focuses on its substantial equivalence to predicate devices, biocompatibility, and mechanical/physical property testing. It does not mention any AI components, algorithms, or performance metrics typically associated with AI/ML device evaluations.
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).