(22 days)
Bard® Mesh is indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects.
Bard® Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.
The Bard® Mesh is a nonabsorbable, sterile mesh designed for the reinforcement of soft tissue where weakness exists, i.e., repair of hernias and chest wall defects. The Bard® Mesh Pre-Shaped is a nonabsorbable, pre-trimmed sterile mesh designed for reinforcement of inguinal hernias. The Bard® Mesh is offered in several sizes of rectangular flat sheets and in several pre-shaped configurations, known as Bard® Mesh Pre-Shaped. Bard® Mesh product family products consist of the standard, rectangular or square sizes which can be trimmed as needed to provide surgeons with more freedom to customize the prosthesis prior to implantation. The Bard® Mesh portfolio currently ranges from 1" x 4" to 10" x 14" rectangle mesh. The Bard® Mesh is comprised of knitted polypropylene monofilaments in a square or rectangular flat sheet with selvage edges. The Bard Mesh Pre-Shaped is comprised of knitted polypropylene monofilaments in a pre-shaped configuration with a pre-cut into a shape commonly used by surgeons to protect the spermatic cord or similar structure as part of an inguinal hernia repair. All clinical, biological, and technical characteristics of the Bard® Mesh and Bard® Mesh Pre-Shaped are identical except that Bard® Mesh Pre-Shaped is only indicated for inguinal hernias due to the pre-cut/pre-shaped nature of the product.
The provided document is an FDA 510(k) clearance letter for a medical device called Bard® Mesh. However, this document does not contain the information typically found in a study demonstrating how an AI/algorithm-driven device meets acceptance criteria.
The Bard® Mesh is a surgical mesh, a physical medical device used to reinforce soft tissue, such as in hernia repair. It is a Class II device, and the clearance is based on its substantial equivalence to a preamendment predicate device (meaning it was marketed before May 28, 1976).
The document specifically mentions:
- "As there are no new or increased risks identified, no verification or validation activities are required for these labeling changes. Design verification testing was conducted to support the performance of the pre-shaped configuration." This indicates that for this type of physical device and the nature of the changes (labeling and a pre-shaped configuration), extensive clinical studies or complex performance evaluations are not required in the same way they would be for a novel diagnostic or AI-powered device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic algorithms, is not present in this 510(k) letter. This clearance is based on the device's established technological characteristics and historical use, demonstrating its equivalence to a long-marketed product, rather than proving performance against specific acceptance criteria through a new study as would be done for an AI device.
§ 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.