(117 days)
The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue and is also intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
The Miromatrix Biological Mesh is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.
The provided text is a 510(k) summary for the Miromatrix Biological Mesh, which is a surgical mesh. This document describes the device, its intended use, and its substantial equivalence to a predicate device. It primarily focuses on a labeling change rather than a new medical AI device or diagnostic algorithm.
Therefore, the requested information regarding acceptance criteria and performance studies for an AI/diagnostic algorithm cannot be extracted from this document. The document describes a biological mesh and a change to its instructions for use (allowing quilting of multiple meshes). The "performance data" mentioned (Section 7) refers to a risk analysis and verification/validation activities related to the quilting of the mesh, not to the performance of an AI or algorithmic medical device in a clinical setting.
Specifically, there is no mention of:
- A table of acceptance criteria and reported device performance for an AI/diagnostic algorithm.
- Sample sizes for test sets, data provenance, or training sets for an AI.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI.
- Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
- Standalone performance studies for an AI algorithm.
- Types of ground truth for an AI (pathology, outcomes data, etc.).
The "acceptance criteria" referred to in the document are about the quilted mesh meeting pre-determined acceptance criteria for the individual cleared mesh (a physical biological product), not for an AI.
§ 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.