The proposed Composix E/X Mesh will be elliptical in shape and manufactured from a single layer of knitted polypropylene monofilament. A single layer of expanded polytetrafluoroethylene (ePTFE) will be attached to this mesh with polytetrafluoroethylene (PTFE) monofilament thread. The peripheral edge of the polypropylene mesh will be heat sealed to the ePTFE layer.

AI/ML Overview

The provided text is a 510(k) summary for the Composix E/X Mesh, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.

Therefore, many of the requested categories (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, specific ground truth types with numbers) are not applicable to this type of regulatory submission and information provided.

However, I can extract the information that is present:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: Non-toxic and non-sensitizing to biological tissues consistent with intended use.	Biocompatibility test results show that the material used in the design and manufacture of the device are non-toxic and non-sensitizing to biological tissues consistent with their intended use.
Bench Testing: Materials and design meet established specifications for consistent performance during intended use.	Laboratory test results demonstrate that the materials chosen and the design utilized in manufacturing the Composix E/X Mesh will meet the established specifications necessary for consistent performance during their intended use.

Study Details (Information Not Applicable or Not Provided in this Document)

Sample size used for the test set and the data provenance: Not applicable. This document refers to biocompatibility and bench testing, not a clinical study with a "test set" in the context of AI/diagnostic device evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established by experts for this type of device submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 a mesh implant, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly described in terms of a "ground truth" for a diagnostic study. The "ground truth" for biocompatibility would be the established safety profiles for the materials, and for bench testing, it would be the pre-defined engineering specifications for mechanical properties.
The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE COMPOSIX E/X MESH

A. Submitter Information

Submitter's Name: Address:

Telephone: Fax: Contact Person: Date of Preparation: Davol, Inc. Subsidiary of C. R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920 401-463-7000 ext. 2529 401-463-3845 Ruth C. Forstadt August 25, 2000

B. Device Name

Composix E/X Mesh

Predicate Device Name C.

Trade name: Composix Mesh (Davol Inc.) SpermaTex Mesh (Davol Inc.)

D. Device Description

E. Intended Use

The Composix E/X Mesh is intended for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

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

The Composix E/X Mesh and the predicate Composix Mesh have the same intended use, which is for the reconstruction of soft tissue deficiencies, such as the repair of hernias and chest wall defects. The technological characteristics are the same or similar to the predicate

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devices in that the materials used to manufacture these products are similar to the predicate polypropylene and ePTFE meshes. Differences include the material used to attach the layers, the shape, the number of layers of mesh, the thickness of the ePTFE layer and the edge design.

G. Performance Data

Biocompatibility and bench testing have been completed and support the safety and effectiveness of the Composix E/X Mesh for its intended use. The biocompatibility test results show that the material used in the design and manufacture of the device are non-toxic and non-sensitizing to biological tissues consistent with their intended use.

Laboratory test results demonstrate that the materials chosen and the design utilized in manufacturing the Composix E/X Mesh will meet the established specifications necessary for consistent performance during their intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2000

Ms. Ruth C. Forstadt Regulatory Affairs Administration Davol. Inc. 100 Sockanossett Crossroad Canston, Rhode Island 02920

Re: K002684 Trade Name: Composix E/X Mesh Regulatory Class: II Product Code: FTL Dated: August 25, 2000 Received: August 28, 2000

Dear Ms. Forstadt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Ruth C. Forstadt

This letter will allow you to begin marketing your device as described in your 510(k) This letter will allow you to begin marketing your also and ence of your device to a
premarket notification. The FDA finding of substantial equivalence of your device and th premarket notification. The FDA miding of substance of subscribed 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 If you desire specific advice for your actives and as a suces), please contact the Office of and additionally 809.10 for in Vitto diagnolice as researchs on the promotion and Compliance at (501) 594-4395. Aduntonatify office of Compliance at (301) 594-4639.
advertising of your device, please contact the Office of Compliance to promories Also, please note the regulation entitled, "Misbranding by reference to premarket Also, please note the regulation cities, " maller general information on your responsibilities under the notification" (21 CFK 807.97). Other general Manufacturers Assistance at its toll-free Act may be obtained from and 1443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N Millhuser

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: _Composix E/X Mesh

Reconstruction of soft tissue deficiencies, such as for Indications for Use: the repair of hernias and chest wall defects.

14002684

(Please do not write below this line – Continue on another page if needed)

.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801,109)

(Division Sign-Off)

Division of General Restorative, Devices 510(k) Number _ 00 2684 Over-the Counter Use

(Optional Format 1-2-96)

Davol Inc. 510(k) for Composix E/X Mesh August 25, 2000

CONFIDENTIAL

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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.