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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):

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.

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Indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects.

The proposed Bard Soft Mesh is a single layer of mesh constructed from polypropylene monofilament with a diameter of approximately 0.004 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 polypropylenc meshes. The proposed device is manufactured utilizing a strong knit design that allows for bi-directional flexibility and tailoring in any direction. The proposed device will be marketed as a stcrile, single use device and will be available in several sizes of rectangular sheets and pre-shaped forms. The option to restcrilize unused mesh has been provided in the instructions for use.

The provided text describes a 510(k) premarket notification for a medical device called "Bard Soft Mesh." This documentation is for regulatory clearance based on substantial equivalence rather than a clinical trial demonstrating efficacy against specific acceptance criteria. Therefore, most of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not applicable or cannot be extracted from this type of regulatory submission.

The document primarily focuses on demonstrating that the Bard Soft Mesh is substantially equivalent to predicate devices already on the market, based on its materials, design, and intended use, supported by biocompatibility and bench testing.

Here's a breakdown of the information that can be extracted or that is not applicable:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Biocompatibility (non-toxic, non-sensitizing)	"The biocompatibility test results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues consistent with its intended use."
   Meeting established specifications for consistent performance during intended use (related to material and design)	"Laboratory test results demonstrate that the material chosen and the design utilized in manufacturing Bard Soft Mesh will meet the established specifications necessary for consistent performance during its intended use."
   Similar physical attributes and performance characteristics as predicates	"The proposed device has similar physical attributes and performance characteristics as the predicates Bard Mesh, ProLite Ultra and Mersilene Mesh. Furthermore, it has the same materials and similar manufacturing methods as the predicate Bard Mesh. The key differences in the proposed device compared to the predicate devices is in the diameter of the polypropylene monofilaments and the knit pattern of the mesh... to create a thinner, lighter weight mesh while also reducing the amount of material... and to allow for a more even stretch in both directions of the prosthesis." (Implies these changes still result in similar performance, confirmed by bench testing).
   Intended Use	"Bard Soft Mesh and the predicate Bard Mesh have an identical intended use. Both devices are indicated to reinforce soft tissue where weakness exists, i.c., repair of hernias and chest wall defects."

   Note: The "acceptance criteria" here are drawn from the statements made about the product's performance relative to its intended use and predicate devices, which are typical for a 510(k) submission.

2. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. The document mentions "biocompatibility and bench testing" but does not detail the sample sizes for these tests.
   • Data Provenance: Not specified, but likely internal lab testing conducted by Davol, Inc. This is not a clinical study involving human patients; it refers to laboratory and material testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable as this is not a study involving expert consensus on images or clinical data. The "ground truth" for biocompatibility and bench testing would be the measured properties relative to established standards or predicate device properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable, as this is not a study requiring adjudication of clinical or imaging data.

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:

   • Not applicable. This is not an AI/software device and no MRMC study was performed or is relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable, as this is not an AI/software device. The "standalone" performance here would refer to the physical and biological properties of the mesh itself, which were assessed through bench and biocompatibility testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the performance data mentioned would be based on:
     • Biocompatibility Standards: Results compared against established safety standards for biological tissues.
     • Material Science Specifications: Measured physical properties (e.g., tensile strength, porosity, flexibility) compared against engineering specifications and predicate device properties.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that uses a "training set."

9. How the ground truth for the training set was established:

   • Not applicable, as there is no training set.

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