The ULTRAPRO COMFORT PLUG Partially Absorbable Hernia Repair Device is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

Device Description

ULTRAPRO COMFORT PLUG is a sterile, single-use partially absorbable hernia repair device designed for open extra-peritoneal abdominal wall repair, particularly groin hernia repair, to provide permanent support during and following wound healing. ULTRAPRO COMFORT PLUG consists of a three-dimensional plug, which fills the defect and a flat pre-shaped onlay patch, which lays on the defect to reinforce the weak area around the defect. The Plug is composed of an undyed ULTRAPRO Mesh. Dyed ribs, made from dyed (D&C Violet No. 2) polydioxanone polymer film, are laminated to the Plug mesh. The onlay patch is a pre-shaped, dyed ULTRAPRO Mesh. The ULTRAPRO Mesh is manufactured from approximately equal parts of absorbable poliglecaprone 25 monofilament fibers and non-absorbable polypropylene monofilament fibers. The device is available in different sizes.

AI/ML Overview

This document describes a 510(k) submission for the ULTRAPRO COMFORT PLUG™ Partially Absorbable Hernia Repair Device. This is a medical device and not an AI/ML-based diagnostic system, thus many of the requested criteria (like sample size for test/training, number of experts, MRMC studies, ground truth establishment, etc.) are not applicable to this type of regulatory submission. The performance assessment for this device focuses on biocompatibility, physical dimensions, shelf life, and animal model efficacy, rather than diagnostic accuracy metrics common in AI/ML studies.

Here's a breakdown of the available information based on your request, highlighting what is not applicable:

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

The document does not present a formal table of quantitative acceptance criteria for device performance with specific metrics like sensitivity, specificity, or AUC, as would be common for diagnostic AI/ML devices. Instead, the device's performance is demonstrated through a comprehensive testing program that confirms safety and effectiveness in line with its intended use and provides substantial equivalence to predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility (per ISO 10993-1:2009)	Passed tests for cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, subchronic toxicity, genotoxicity, and local tissue response and absorption study.
Device Dimensional Measurement	Bench testing conducted for device dimensional measurement and comparison, indicating conformance. Specific measurements or criteria are not detailed in this summary.
Shelf Life	Shelf life testing was conducted. Specific duration or stability metrics are not detailed in this summary.
Performance/Efficacy in Animal Model (Hernia Repair)	Efficacy study evaluating mesh compression, tissue integration, and tissue reaction was conducted in an animal model. Infection potentiation study was also done. Results demonstrate the device "performs as intended." Specific quantitative outcomes are not detailed.
Substantial Equivalence to Predicate Devices (ULTRAPRO PLUG™, BARD Mesh Perfix™ Plug)	Performance data (bench and animal testing) supports that the device is "as safe and as effective" as the predicate devices for the intended use, and shares "same intended use, fundamental scientific technology, and principles of operation."

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

Sample Size for Test Set: Not explicitly stated in terms of patient numbers or a "test set" in the context of diagnostic data. The document mentions "bench and animal testing." For animal studies, specific numbers of animals are not provided in this summary.
Data Provenance: The studies were conducted by the manufacturer, Johnson & Johnson MEDICAL GmbH, in Germany. The nature of the studies (biocompatibility, bench, animal models) means the data is prospective for the purpose of demonstrating device safety and performance. No patient data provenance (e.g., country of origin, retrospective/prospective) is relevant here as it's a hardware medical device submission.

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

Not Applicable. This is a hardware medical device, not an AI/ML diagnostic. There is no "ground truth" established by human experts in the way that would apply to image interpretation or diagnostic accuracy studies. The "ground truth" for this device's performance is based on established biological and engineering principles, and validated test methods (e.g., ISO standards for biocompatibility).

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

Not Applicable. No adjudication method is relevant as this is not a diagnostic accuracy study involving human readers.

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 a physical medical device (surgical mesh), not an AI-assisted diagnostic tool.

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

Not Applicable. This is a physical medical device. There is no "algorithm only" performance.

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

The "ground truth" for this device's acceptance is based on:
- Validated Test Standards: ISO 10993-1:2009 for biocompatibility.
- Engineering Specifications: For device dimensions and physical properties.
- Biological Response in Animal Models: Evidence of "efficacy study evaluating mesh compression, tissue integration, and tissue reaction and infection potentiation study."
- Comparison to Predicate Devices: Demonstrating equivalence in materials, function, and performance to legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This device is not an AI/ML model that requires a training set.

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

Not Applicable. As above, no training set or associated ground truth.

Summary

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510(K) SUMMARY

MAY 3 0 2014

Applicant:	Ethicon Inc.P.O. Box 151Route 22 WestSomerville, NJ 08876USAPhone: +1-908-218-3323Fax: +1-908-218-2595
Date:	May 12, 2014
Contact Person:	Rey Librojo
Proprietary Device Name:	ULTRAPRO COMFORT PLUGTMPartially Absorbable Hernia Repair Device
Common Device Name:	Surgical Mesh
Classification:	Class IIRegulation Number 878.3300 - Surgical Mesh, polymeric;Product Code: FTL
Predicate Devices:	ULTRAPRO PLUG™ (ETHICON, Inc.) - K070224;BARD Mesh Perfix™ Plug (Davol, Inc.) - K922916
Manufacturer:	Johnson & Johnson MEDICAL GmbHRobert-Koch-Strasse 122851 NorderstedtGermany

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Description of the Device Subject to Premarket Notification:

ULTRAPRO COMFORT PLUG™ is a sterile, single-use partially absorbable hernia repair device designed for open extra-peritoneal abdominal wall repair, particularly groin hernia repair, to provide permanent support during and following wound healing. ULTRAPRO COMFORT PLUG™ consists of a three-dimensional plug, which fills the defect and a flat pre-shaped onlay patch, which lays on the defect to reinforce the weak area around the defect. The Plug is composed of an undyed ULTRAPRO™ Mesh. Dyed ribs, made from dyed (D&C Violet No. 2) polydioxanone polymer film, are laminated to the Plug mesh. The onlay patch is a pre-shaped, dyed ULTRAPRO™ Mesh. The ULTRAPRO™ Mesh is manufactured from approximately equal parts of absorbable poliglecaprone 25 monofilament fibers and non-absorbable polypropylene monofilament fibers. The device is available in different sizes.

Indications for Use:

The ULTRAPRO COMFORT PLUG™ Partially Absorbable Hernia Repair Device is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

Summary of Technological Characteristics of New Device to Predicate Devices:

Similarity:

The principle of operation and fundamental scientific technology of the proposed device are equivalent to the predicate devices. ULTRAPRO COMFORT PLUG™ and the predicate devices function in the same manner - they are designed as plug plus onlay patch devices for open extraperitoneal abdominal wall repair, particularly groin hernia repair. The polymer materials in the proposed device is identical to that of Ultrapro Plug, which is composed with approximately equal parts of absorbable poliglecaprone 25 monofilament fibers and non-absorbable, polypropylene monofilament fibers. The mash knitting structure of both plug and onlay patch of ULTRAPRO COMFORT PLUG™ is the same as the onlay patch material of ULTRAPRO Plug the proposed device has similar 3-D physical shapes as that of Bard Mesh Perfix Plug. Difference:

The plug material for proposed device is composed of undyed ULTRAPRO™ Mesh. Dyed ribs, made from dyed (D&C Violet No. 2) polydioxanone polymer film, are laminated to the Plug mesh to provide better visibility to the plug for ease of insertion into the defect and fixation.

Performance Data:

ULTRAPRO COMFORT PLUG™, Partially Absorbable Hernia Repair Device underwent an extensive safety and performance testing program, including bench and animal testing, to support that the device meets the requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate devices. The tests conducted include:

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Biocompatibility testing in accordance to the tests recommended in the ISO 10993-. 1:2009 standard including cytotoxicity, sentitization, acute systemic toxicity, pyrogenicity, subchronic toxicity, genotoxicity, and local tissue response and absorption study
Bench testing including device dimensional measurement and comparison, and shelf life . testing
Performance testing in animal model including efficacy study evaluating mesh . compression, tissue integration, and tissue reaction and infection potentiation study.

The ULTRAPRO COMFORT PLUG™ Partially Absorbable Hernia Repair Device has the same intended use, fundamental scientific technology, and principles of operation as its predicate devices. Performance data demonstrates that the device is as safe and as effective as the predicate devices for the intended use. Thus we conclude that the proposed device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Asenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

May 30, 2014

Ethicon, Inc. Reynaldo Librojo Director, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, NJ 08876

Rc: K133198

Trade/Device Name: ULTRAPRO COMFORT PLUG Partially Absorbable Hernia Repair Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: May 22, 2014 Received: May 28, 2014

Dear Mr. Reynaldo Librojo,

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 enacument 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). and Cosmetic room reat 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code 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

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Page 2 - Mr. Librojo

CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ethicon Inc. October 2013

INDICATIONS FOR USE STATEMENT 4

510(k) No (if known):	K133198
Device Name:	ULTRAPRO COMFORT PLUG TM
	Partially Absorbable Hernia Repair Device
Indications for Use:	The ULTRAPRO COMFORT PLUG TM Partially Absorbable Hernia Repair Device is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

V Prescription Use __ (Part 2) 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)

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Peter L. Hudson -S

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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.