(73 days)
Bard® Large Pore Soft Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Bard Large Pore Soft Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.
The proposed Bard Large Pore Soft Mesh product is a single layer of mesh constructed from polypropylene monofilament with a diameter of approximately 0.048 inches. The mesh is knitted to form a strong, porous, support material. The small diameter of the polypropylene monofilament allows for a thin profile and creates a mesh with increased flexibility and a reduced amount of material compared to traditional monofilament polypropylene meshes. It is manufactured utilizing a strong knit design that allows for bi-directional flexibility and tailoring in any direction and will be marketed as a sterile, single use device available in several sizes of rectangular sheets and pre-shaped forms. Predicates Bard Mesh, Mersilene Mesh, and Prolene Soft are sterile, single use products that can be tailored as well.
The provided document is a 510(k) summary for a surgical mesh device (Bard® Large Pore Soft Mesh). It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain the detailed study information typically found in a clinical study report or a more comprehensive premarket submission that would include acceptance criteria, sample sizes, ground truth establishment, or expert details for evaluating a diagnostic AI device.
Therefore, I cannot fulfill most of your request as the information is not present in the provided text.
Here's what I can provide based on the text:
1. A table of acceptance criteria and the reported device performance
The document mentions "established specifications necessary for consistent performance" and that "Laboratory test results demonstrate that the material chosen and the design utilized in manufacturing Bard Large Pore Soft Mesh will meet the established specifications". However, it does not list the specific acceptance criteria or the quantitative reported device performance values for those criteria. It only provides a qualitative statement of compliance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in the document) | (Not specified, only a qualitative statement of meeting criteria) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "bench testing" but does not detail sample sizes, data provenance, or study design (retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. As this is a surgical mesh (a physical device), the concept of "ground truth" established by experts in the context of diagnostic AI is not directly applicable in the same way. The evaluation would likely involve material scientists, surgeons, and pathologists for biocompatibility, but their roles and numbers are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as the device is a physical surgical mesh, not an AI diagnostic tool. Therefore, a MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical surgical mesh, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, "ground truth" would likely relate to material properties (e.g., tensile strength, pore size, weave pattern), biocompatibility (e.g., cytotoxicity, sensitization), and potentially animal model outcomes for tissue integration. However, the document only qualitatively states that "Biocompatibility and bench testing have been completed" and that "Laboratory test results demonstrate that the material chosen and the design utilized in manufacturing Bard Large Pore Soft Mesh will meet the established specifications." It does not detail how "ground truth" for these measurements was established.
8. The sample size for the training set
This information is not applicable/provided. For a physical medical device, there isn't a "training set" in the sense of machine learning algorithms. Material properties are characterized based on testing of manufactured batches.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated above.
§ 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.