The Medlinx Surgical Mesh is intended to be implanted to reinforce soft tissue where weakness exists for the repair of hernias and other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Description

The Medlinx Surgical Mesh is a sterile, implantable, single-layer polymeric mesh that is comprised of non-absorbable polyvinylidene fluoride (PVDF) and absorbable poly(1,4-butylene adipate) (PBA). The PBA plasticizer increases the flexibility of the mesh, and it is partially absorbed once implanted.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the "Medlinx Surgical Mesh." This document focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for performance in a clinical study with an AI device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI device is not applicable to this document.

However, I can extract information related to the device's characteristics and the types of testing conducted to support its substantial equivalence.

Here's a breakdown of what can be inferred from the provided text, addressing your questions where applicable, and stating "Not Applicable" or "Not Provided" when the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional medical device (surgical mesh), not an AI device, there are no "acceptance criteria" in the sense of predictive performance metrics (like sensitivity, specificity, AUC) against a ground truth. Instead, the "performance" relates to its material characteristics and biological interactions compared to predicate devices.

Performance Metric Area	Reported Medlinx Surgical Mesh Performance
Biocompatibility	"The biocompatibility testing showed the comparable safety profile of the Medlinx Surgical Mesh and the predicates." (Tests included: In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, In Vitro Bacterial Reverse Mutation (AMES), In Vitro Chromosome Aberration, In Vitro Mammalian Cell Gene Mutation, Intramuscular Implantation, In Vitro Hemolysis, Pyrogenicity, Sub-Chronic Systemic Toxicity)
Bench Testing	"Bench testing demonstrated that the device is substantially equivalent for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result." (Tests included: Mesh Density, Tensile Strength, Device Stiffness, Suture Pullout Strength, Burst Strength, Tear Resistance, Residual levels of heavy metals, Polymer purity, Biodegradation, PBA Extraction, Expiration Dating) Specific numerical acceptance criteria and direct performance values (e.g., "Tensile Strength > X MPa") are not provided in this summary, only the conclusion of substantial equivalence.
Animal Testing	Implied similarity to predicates based on the guidance followed, but no specific performance metrics or outcomes are directly stated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable. This is not an AI device evaluated on a clinical test set. The "testing" involved laboratory bench tests, in vitro tests, and animal studies. Specific sample sizes for these tests are not provided in this summary.
Data Provenance: Not applicable. The tests are laboratory-based and animal studies, not human clinical data with provenance like country of origin.

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)

Not applicable. This is a traditional medical device. "Ground truth" in the context of expert consensus for AI model evaluation is not relevant here. The "truth" for these tests comes from established scientific and engineering principles (e.g., measuring tensile strength, observing cellular reactions).

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

Not applicable. No expert adjudication for a test set is described.

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 device. No MRMC study was conducted.

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

Not applicable. This is not an AI device.

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

Not applicable in the AI context. For this medical device, the "truth" is established through:
- Biocompatibility Standards: Compliance with established biological safety guidelines (e.g., ISO 10993 series, implicitly followed as per the guidance document).
- Engineering Standards: Measurement against defined physical and mechanical properties (e.g., tensile strength, burst strength as per ASTM or similar standards, implicitly followed).
- Animal Models: Observations in animal studies to assess in vivo response to implantation.

8. The sample size for the training set

Not applicable. This is not an AI device; there is no training set.

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

Not applicable. This is not an AI device; there is no training set.

Summary

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510(k) Premarket Notification

Medlinx Acacia Pte Ltd

Medlinx Surgical Mesh

510(k) Summary

DEC 1 3 2012

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for the Medlinx Surgical Mesh is provided below.

Device Common Name: Polymeric Surgical Mesh

Device Proprietary Name: Medlinx Surgical Mesh

Submitter:

Medlinx Acacia Pte Ltd 10 Anson Road #31-10 International Plaza Singapore 079903

Date Prepared:

November 6, 2012

21 CFR 878.

Classification Regulation:

Product Code:

Class:

Panel:

R. A. Fisher

General & Plastic Surgery Devices

FTL

Predicate Devices:

Ethicon, Inc's ULTRAPRO Mesh (K033337) C.R. Bard's Marlex Mesh (K922916)

3300

Indication for Use:

Device Description:

Comparison to the Predicate

The Medlinx Surgical Mesh has similar indications for use and technological characteristics as Ethicon Inc.'s UltraPro Mesh and C.R. Bard's Marlex Mesh. All

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510(k) Premarket Notification

K120844 Page 2/2

Medlinx Acacia Pte Ltd Medlinx Surgical Mesh

three meshes are manufactured with a non-absorbable polymer material. The Medlinx Surgical Mesh and the UltraPro Mesh both have a partially absorbable polymer material. All three are available in a similar range of sizes.

Mechanical testing; biocompatibility testing and animal testing were conducted per the recommendations in: Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance - Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh," dated March 2, 1999." The following tests were conducted:

Biocompatibility Testing In Vitro Cytotoxicity Skin Sensitization (Maximization Method) Intracutaneous Reactivity Acute Systemic Toxicity In Vitro Bacterial Reverse Mutation (AMES) In Vitro Chromosome Aberration In Vitro Mammalian Cell Gene Mutation Intramuscular Implantation In Vitro Hemolysis Pyrogenicity Sub-Chronic Systemic Toxicity

Bench Testing Mesh Density Tensile Strength Device Stiffness Suture Pullout Strength Burst Strength Tear Resistance Residual levels of heavy metals Polymer purity Biodegradation PBA Extraction Expiration Dating

The biocompatibility testing showed the comparable safety profile of the Medlinx Surgical Mesh and the predicates. Bench testing demonstrated that the device is substantially equivalent for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Summary of Substantial Equivalence:

Based on the indications for use, technological characteristics and performance test results, the Medlinx Surgical Mesh is substantially equivalent to the predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 2, 2013

Medlinx Acacia Pte Ltd % Biologics Consulting Group Mr. Stephen P. Rhodes Senior Consultant, Medical Devices 3502 Dundee Drive Chevy Chase, Maryland 20815

Re: K120844

Trade/Device Name: Medlinx Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: December 13, 2012 Received: December 13, 2012

Dear Mr. Rhodes:

This letter corrects our substantially equivalent letter of December 13, 2012.

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 (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 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Stephen P. Rhodes

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

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3.0 Indications for Use Statement

510(k) Number (if known):_K120844

Device Name: Medlinx Surgical Mesh

Indications for Use:

The Medlinx Surgical Mesh is intended to be implanted to reinforce soft tissue where weakness exists for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

ゃ

Prescription Use __ × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(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)

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K120844

Page 1 of 1

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.