(25 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 pelvic 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.
BioBlanket™ Surgical Mesh is comprised of a single layer porous, cross-linked collagen patch that is supplied sterile and for one-time use.
The provided document is a 510(k) summary for the Kensey Nash Corporation's BioBlanket™ Surgical Mesh. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance data derived from clinical studies with specified acceptance criteria in the same way an AI/ML device would.
Therefore, the information requested in the prompt, which is typically relevant for AI/ML device performance studies, is not explicitly available within this 510(k) summary. These include:
- Acceptance criteria and reported device performance table: The document states the device "passed the requirements of all tests" but does not define specific acceptance ranges or thresholds.
- Sample size and data provenance for test set: Not applicable for a device of this nature as there's no "test set" in the context of AI/ML evaluation. Pre-clinical or clinical studies for surgical meshes would involve animal or human subjects, but this detail is not provided.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone algorithm performance: Not applicable.
- Type of ground truth used: For surgical meshes, "ground truth" would typically come from histological analysis, biomechanical testing outcomes, or clinical outcomes, but this is not specified.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
Instead, the document states:
"BioBlanket™ Surgical Mesh has been subjected to biocompatibility, integrity, in-vitro and in-vivo performance tests. The device passed the requirements of all tests."
This indicates that various types of non-clinical (and possibly some clinical) tests were performed, and the device met the internal requirements of those tests. However, the specific acceptance criteria and detailed results are not part of the 510(k) summary provided. Substantial equivalence is primarily based on similarity in intended use, technological characteristics, performance, and material to previously cleared 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.