(360 days)
Lyograft® is intended for implantation to repair, reinforce and/or supplement soft tissue.
Lyograft is a biological surgical mesh comprised of pure collagen made of bovine pericardium. It is a single layered membrane of connective tissue with the collagen fibers running in three dimensions. Lyophilization causes the formation of a mesh, free of non-collagenous components, with a loose fibrous structure and large communicating pores. Lyograft is a long-term implant that will be incorporated into the patient's tissue over time.
Lyograft is supplied in various sizes ranging from 8x14cm to 20x30cm. It is provided sterile within a double blister package and is for single use. Lyograft is rehydrated in a physiological saline solution and cut to size using aseptic technique prior to use. It is recommended to suture Lyograft in place using nonabsorbable sutures.
The provided text is a 510(k) Summary documenting the substantial equivalence determination for the Lyograft surgical mesh. It focuses on comparing the Lyograft device to a predicate device, TUTOMESH®, rather than presenting acceptance criteria and performance data for a novel AI/software device.
Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/software medical device.
The information you are asking for, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance," are typically relevant to the validation of AI-powered diagnostic or prognostic devices, especially those that interpret medical images or data. The Lyograft device is a physical surgical mesh.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.