(264 days)
BioBlanket™ Surgical Mesh is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to defects of the thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvice floor, hernias, suture line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one time use.
DioBlanket™ Surgical Mesh is comprised of a single layer porous, cross-linked collagen patch that is supplied sterile and for one-time use.
The provided text describes a submission for a 510(k) premarket notification for the BioBlanket™ Surgical Mesh. This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices, and as such, it focuses on demonstrating equivalence rather than establishing novel performance criteria through clinical trials designed to prove efficacy or specific performance metrics against acceptance criteria.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or its provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Details on a standalone (algorithm only) performance study.
- The type of ground truth used for a test set (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the document states:
Performance Data:
"BioBlanket™ Surgical Mesh was subjected to biocompatibility, integrity, in-vitro and invivo performance tests. The device passed the requirements of all tests."
This statement indicates that the device underwent a set of pre-defined tests (biocompatibility, integrity, in-vitro, and in-vivo) and met their respective requirements. However, the specific acceptance criteria for these tests and the detailed results are not provided in this summary. The focus is on demonstrating that the device is "substantially equivalent in terms of intended use, technological characteristics, performance and material" to previously cleared predicate devices.
§ 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.