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.

Device Description

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.

AI/ML Overview

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.

Summary

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Kos 2155

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7.0 510(k) Summary of Safety and Effectiveness:

A. Submitter Information:

(((1) 2 0 2005

Submitter's Name:	Davol, Inc.
Address:	Subsidiary of C. R. Bard, Inc.100 Sockanossett CrossroadCranston, RI 02920
Telephone:	401-463-7000, Ext. 2386
Fax:	401-463-3845
Contact Person:	Lucinda L. Fox

B. Device Name:

Trade Name:	Bard® Large Pore Soft Mesh and Soft Mesh Pre-shaped
Common/Usual Name:	Surgical Mesh
Classification Name:	Surgical Mesh, Polymeric

C. Predicate Device Names:

Trade Name:	Bard Mesh (Davol Inc.)
Trade Name:	Ethicon Mersilene Polyester Fiber Mesh (Ethicon, Inc.)
Trade Name:	Ethicon Prolene Soft Polypropylene Mesh (Ethicon, Inc.)

D. Device Description:

E. Intended Use:

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KOS-2155

212

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 inquinal hernia defects.

F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

Bard Soft Mesh product and the Predicate Bard Mesh have the same indication: reinforce soft tissue, i.e., repair of hernias and chest wall defects.

The Proposed Product has similar physical attributes and performance characteristics as the Predicates Bard Mesh, Mersilene Mesh, and Prolene Soft Mesh. Furthermore, it has the same materials and similar manufacturing methods as the Predicate Bard Mesh.

The key differences in the Proposed Product compared to the Predicate Products are the diameter of the polypropylene monofilament and the knit pattern of the mesh. In order to create a thinner, lighter weight mesh and reduce the amount of material used in the mesh compared to traditional monofilament polypropylene meshes, the Proposed Product is constructed from monofilaments with a diameter of approximately 0.048 inches. However, the weights (grams/square inch) of both Predicates Prolene Soft (0.0287) and Mersilene Mesh (0.0274) are comparable to the Soft Mesh (0.0282).

G. Performance Data

Biocompatibility and bench testing have been completed and support the safety and effectiveness of Bard Large Pore Soft Mesh for its intended use. 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. Laboratory test results demonstrate that the material chosen and the design utilized in manufacturing Bard Large Pore Soft Mesh will meet the established specifications necessary for consistent performance during its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Public Health Service

OCT 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lucinda L. Fox Manager, International Regulatory & Clinical Affairs Davol Inc. Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, Rhode Island 02920

Rc: K052155

Trade/Device Name: Bard" Large Pore Soft Mesh and Soft Mesh Prc-shaped Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 4, 2005 Received: August 8, 2005

Dear Ms. Fox:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) rins ictir witi anow you to organization of substantial equivalence of your device to a legally premated predicated on "caresults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you don't office of Compliance at (240) 276-0115. Also, please note the regulation entitled, Coniact the Office of Courter notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation on your corpumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Barbara Precht
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1052155 Indications for Use

510(k) Number (if known): Unknown

Bard® Large Pore Soft Mesh and Soft Mesh Pre-shaped Device Name:

indications for Use:

Prescription Use 7 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Beulare Mueh)

Division of General, Restorative, and Neurological Devices

E10(k) Ni

FDA Page 1 of 1

Davol Inc.
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ONFIDENTIAL

Regulation Number and Section

§ 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.