(85 days)
Bard® Soft Mesh is indicated for the repair of ventral, incisional, and inguinal hernias.
Bard® Soft Mesh Pre-Shaped is indicated for the repair of inguinal hernias.
The Bard® Soft Mesh is a nonabsorbable, sterile mesh designed for reinforcement of soft tissue deficiencies in adults with ventral, incisional, and inguinal hernias. The Bard® Soft Mesh Pre-Shaped is a nonabsorbable, sterile mesh designed for reinforcement of soft tissue deficiencies in adults with inguinal hernias. The knit construction allows the mesh to be stretched in both directions, in order to accommodate and reinforce tissue defects. The Bard® Soft Mesh is comprised of knitted polypropylene monofilaments in a rectangular flat sheet ranging from 2" x 4" to 12" x 12" with smooth radiused corners. The Bard® Soft Mesh Pre-Shaped is comprised of knitted polypropylene monofilaments in a pre-shaped configuration pre-cut into a shape commonly used by surgeons to protect the spermatic cord or similar structure as part of an inguinal hernia repair.
This 510(k) clearance letter pertains to a surgical mesh (Bard Soft Mesh), not an AI/software device. Therefore, the detailed questions about acceptance criteria, study design referencing AI performance, expert consensus, MRMC studies, training and test sets, and ground truth establishment are not applicable to this submission.
The 510(k) is for changes to the labeling of an existing device, with no changes to the device itself. The primary purpose of the submission is to align the labeling with European medical device regulations and to document historical product changes (like adding a new size) that were previously handled via internal documentation.
Here's a breakdown of the relevant information provided in the document:
1. Acceptance Criteria and Device Performance:
Since this 510(k) is not for a new device or a functional change, but rather for labeling updates and documentation of previous minor changes, the concept of "acceptance criteria" for a new device performance study (like for an AI model) does not apply. The acceptance criteria here are implicitly related to demonstrating that the labeling changes and historical product modifications do not impact the safety or effectiveness of the device and maintain substantial equivalence to the predicate device.
The document states: "Through the risk analysis conducted, it was determined that the labeling changes described in this 510(k) do not result in any new or increased risks. As there are no new or increased risks identified, no verification or validation activities are required for these labeling changes."
"Non-clinical testing including mesh thickness, mesh knit construction, mesh pore size, mesh density, tensile strength, device stiffness, ball burst (strength), tear resistance, device stiffness, and suture pull out were considered in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh issued on March 2, 1999. The non-clinical testing supported those historical changes taken under documentation to file, including dimensional line extension, do not impact the safety or effectiveness of the subject device nor do they impact the substantial equivalence between the subject and predicate devices."
Therefore, the "performance" shown is that the device, with its updated labeling and previously documented size extension, continues to meet the physical and mechanical properties expected of a surgical mesh and is substantially equivalent to the predicate.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance | Study Type |
|---|---|---|---|
| Risk Assessment | No new or increased risks from labeling changes or historical modifications. | Determined that labeling changes and historical modifications do not result in any new or increased risks. | Risk Analysis |
| Physical Properties | Maintenance of established physical properties (mesh thickness, knit construction, pore size, density). | Non-clinical testing supported that historical changes (e.g., dimensional line extension) do not impact safety or effectiveness. | Non-Clinical Testing |
| Mechanical Properties | Maintenance of established mechanical properties (tensile strength, device stiffness, ball burst (strength), tear resistance, suture pull out). | Non-clinical testing supported that historical changes (e.g., dimensional line extension) do not impact safety or effectiveness. | Non-Clinical Testing |
| Substantial Equivalence | Subject device remains substantially equivalent to the predicate device. | "The subject device and predicate device have the same intended use and technological characteristics... The subject device... is substantially equivalent to the predicate device." | Comparison Assessment |
2. Sample Size for Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. This submission is based on non-clinical testing of physical device properties and a comparison to a predicate, not clinical studies with a "test set" of patient data for an AI model. The "test set" refers to the specific mesh samples used for physical and mechanical property testing. The document states "Non-clinical testing including mesh thickness, mesh knit construction, mesh pore size, mesh density, tensile strength, device stiffness, ball burst (strength), tear resistance, device stiffness, and suture pull out were considered," implying relevant samples of the mesh were tested, but specific sample numbers are not provided in this summary.
- Data Provenance: Not applicable in the context of patient data. The "data" pertains to the characteristics of the physical mesh device.
3. Number of Experts used to establish ground truth:
- Not applicable. There is no "ground truth" establishment by experts in the context of an AI model's performance on patient data. The non-clinical testing results establish the performance of the physical device.
4. Adjudication Method:
- Not applicable. No expert adjudication process for an AI model's output is relevant to this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not an AI-assisted diagnostic device study.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This is not an algorithm.
7. Type of Ground Truth Used:
- Not applicable in the context of an AI model. The "ground truth" for this device's performance is established by objective non-clinical engineering and material property testing methods as per relevant standards (e.g., those referenced in the 1999 FDA guidance for surgical mesh).
8. Sample Size for Training Set:
- Not applicable. No AI model is being trained here.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
§ 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.