Xylos® Macro-Porous Surgical Mesh is intended to be used for implantation to reinforce and protect soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures. This mesh may be used for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Xylos® Macro-Porous Surgical Mesh is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Xylos® Macro-Porous Surgical Mesh is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

Xylos® Macro-Porous Surgical Mesh is indicated for open and endoscopic procedures and is intended for one-time use only.

Device Description

Xylos® Macro-Porous Surgical Mesh is a flexible, non-resorbable implant composed of microbial-derived cellulose; there are no animal or human derived components in the device. Xylos® Macro-Porous Surgical Mesh is strong, conformable, biocompatible and includes macro-pores to facilitate tissue in-growth. The device is not subject to degradation or weakening by the action of tissue enzymes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Disclaimer: This device is a surgical mesh, not an AI-powered diagnostic tool. Therefore, many of the typical questions related to AI device evaluation (such as multi-reader multi-case studies, effect size of AI assistance, standalone performance, and ground truth establishment for training/test sets in an AI context) are not applicable to this submission. The information provided focuses on the regulatory submission for a physical medical device.

Acceptance Criteria and Device Performance for Xylos® Macro-Porous Surgical Mesh

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing for mechanical properties and biocompatibility. The acceptance criteria are implicit in the claim of "substantial equivalence" to predicate devices, meaning the Xylos® Macro-Porous Surgical Mesh must perform at least as well as, or equivalently to, the predicate devices in the measured physical properties and biocompatibility.

Acceptance Criterion (Implicit)	Reported Device Performance and Evidence
Mechanical Equivalence to specified predicate devices	"Xylos® Macro-Porous Surgical Mesh was subjected to mechanical performance tests typical for surgical mesh products (tensile strength, burst strength, and suture pull out strength). This testing demonstrated that Xylos® Macro-Porous Surgical Mesh is mechanically equivalent to the predicate devices: Pegasus' OrthADAPT Bioimplant (K071065), Ethicon's Mersilene Mesh (Pre-amendment), and Covidien's Parietex Composite Mesh (K040998)."
Sufficient Physical Strength for Intended Use	"Further, animal study results show that Xylos® Macro-Porous Surgical Mesh possesses sufficient physical strength for the intended use."
Biocompatibility Equivalence to specified predicate device	"Xylos® Macro-Porous Surgical Mesh is substantially equivalent in biocompatibility to Xylos® Securian® Tissue Reinforcement Matrix (K083823) because they have the identical material composition." "The material has demonstrated its biocompatibility via testing as defined in ANSI/AAMI/ISO 10993 Biological evaluation of medical devices."

2. Sample Size Used for the Test Set and Data Provenance:

Mechanical Testing: The document does not specify exact sample sizes for the mechanical tests (tensile strength, burst strength, suture pull-out strength). It refers to "mechanical performance tests typical for surgical mesh products."
Animal Study: The document does not specify the sample size for the animal study.
Biocompatibility Testing: The document does not specify the sample size for biocompatibility testing, but indicates it was conducted "as defined in ANSI/AAMI/ISO 10993 Biological evaluation of medical devices."
Data Provenance: The origin of the animals or the specific details of the testing environment (country, etc.) are not provided. The studies appear to be prospective tests conducted specifically for this device's submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable as the submission is for a physical surgical mesh, not an AI device requiring expert interpretation of output. The "ground truth" for this device's performance is established through direct physical and biological testing against established standards and predicate devices.

4. Adjudication Method for the Test Set:

Not applicable for a physical device. Performance is measured objectively through standardized tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This is not applicable. This is not an AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable. This is not an AI device.

7. The Type of Ground Truth Used:

Mechanical Performance: The ground truth is objective measurement against established engineering standards and comparative data from the identified predicate devices.
Biocompatibility: The ground truth is established through adherence to international standards for biological evaluation of medical devices (ANSI/AAMI/ISO 10993) and comparison to a predicate device with identical material composition that was previously cleared for biocompatibility.
Physical Strength for Intended Use: The ground truth is derived from the results of an animal study.

8. The Sample Size for the Training Set:

This is not applicable. This is not an AI device that requires a training set in the machine learning sense. The "training" for this device involved its design and manufacturing processes based on knowledge of similar products and materials.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable. As stated above, this is not an AI device.

Summary

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Xylos® Corporation

AUG 2 5 2011

Section 5: 510(k) Summary

Sponsor:	Xylos Corporation838 Town Center DriveLanghorne, PA 19047
Contact:	Dr. Gonzalo Serafica838 Town Center DriveLanghorne, PA 19047Phone: 215-867-0220 ext. 612Facsimile: 215-741-4804al.serafica@xyloscorp.com
Date submitted:	June 3, 2011
Proprietary Name:	Xylos® Macro-Porous Surgical Mesh
Common Name:	Surgical Mesh
Regulation Classification:	878.3300
Classification Status:	Class II
Product Codes:	FTM
Predicate Device:	Xylos® Securian® Tissue Reinforcement Matrix (K083823)OrthADAPT Bioimplant (K071065), PegasusParietex Composite Mesh (K040998), CovidienMersilene Mesh (Pre-amendment), Ethicon Inc.

Device Description:

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Xylos® Corporation

Indications for Use:

X ylos® Macro-Porous Surgical Mesh is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Xylos® Macro-Porous Surgical Mesh is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

Xylos® Macro-Porous Surgical Mesh is indicated for open and endoscopic procedures and is intended for one-time use only.

Technological Characteristics:

Xylos® Macro-Porous Surgical Mesh is a thin, conformable, non-resorbable surgical mesh intended for use in soft tissue and tendon repairs. Like its predicate devices, it is intended to be sutured in place and provide reinforcement for healing soft tissue and tendon. It is composed of microbial cellulose, a naturally occurring biopolymer hydrogel and contains no animal or human-derived materials. Xylos® Macro-Porous Surgical Mesh has the identical material composition to five previously cleared surgical devices: Xylos® Surgical Mesh (K081882), Xylos® Securian® Tissue Reinforcement Matrix (K083823), Xylos® Porous Surgical Mesh (K090880), Xylos® MTA® Protective Sheet (K090788) and Xylos® Vessel Guard (K100984). The material has demonstrated its biocompatibility via testing as defined in ANSI/AAMI/ISO 10993 Biological evaluation of

CONFIDENTIAL

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Xylos® Corporation

medical devices. It is not subject to degradation or weakening by the action of tissue enzymes. Macro-pores are incorporated into the device to facilitate tissue in-growth.

Xylos® Macro-Porous Surgical Mesh may be easily cut into any desired shape or size without fraying or unraveling. It is presented ready-to-use in a sterile double-pouched package.

Xylos® Macro-Porous Surgical Mesh is substantially equivalent in biocompatibility to Xylos® Securian® Tissue Reinforcement Matrix (K083823) because they have the identical material composition.

Performance Testing:

Xylos® Macro-Porous Surgical Mesh was subjected to mechanical performance tests typical for surgical mesh products (tensile strength, burst strength, and suture pull out This testing demonstrated that Xylos® Macro-Porous Surgical Mesh is strength). mechanically equivalent to the predicate devices: Pegasus' OrthADAPT Bioimplant (K071065). Ethicon's Mersilene Mesh (Pre-amendment), and Covidien's Parietex Composite Mesh (K040998). Further, animal study results show that Xylos® Macro-Porous Surgical Mesh possesses sufficient physical strength for the intended use.

Substantial Equivalence:

Xylos® Macro-Porous Surgical Mesh is substantially equivalent to the following previously cleared devices, Xylos® Securian® Tissue Reinforcement Matrix (K083823), Pegasus' OrthADAPT Bioimplant (K071065), Covidien's Parietex Composite Mesh (K040998) and Ethicon's Mersilene Mesh (Pre-amendment). J Xylos® Macro-Porous Surgical Mesh has the same intended use and the same or similar indications, technological characteristics, and principles of operations as these predicate devices. Performance data demonstrates that Xylos® Macro-Porous Surgical Mesh is mechanically equivalent to Pegasus' OrthADAPT Bioimplant (K071065), Ethicon's Mersilene Mesh (Pre-amendment), and Covidien's Parietex Composite Mesh (K040998). Xylos® Macro-Porous Surgical Mesh is identical in material composition to Xylos® Securian® Tissue

CONFIDENTIAL

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Xylos® Corporation

Reinforcement Matrix (K083823) and therefore, substantially equivalent in regard to biocompatibility. Thus, Xylos® Macro-Porous Surgical Mesh is substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The emblem is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G61 Silver Spring, MD 20993-0002

Xylos Corporation % Dr. Gonzalo C. Serafica VP Technology and Intellectual Property 838 Town Center Drive Langhorne, Pennsylvania 19047

Re: K111584

Trade/Device Name: Xylos® Macro-Porous Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: August 12, 2011 Received: August 15, 2011

Dear Dr. Serafica:

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 misbarading 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 aft the Act or any Federal statutes and regulations administered by other Federal agencies. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Dr. Gonzalo C. Serafica

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 100-1050.

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.html 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 (2) 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 Inc.
(800) 638, 2041 -7 (201) 706 - 700 - 2017 - 11:00 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Millman

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

Enclosure

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Section 4: Indications for Use Statement

510(k) Number: K | | | 5 84

Xylos® Macro-Porous Surgical Mesh Device Name:

Indications for Use:

Xylos® Macro-Porous Surgical Mesh is indicated for open and endoscopic procedures and is intended for one-time use only.

Prescription Use AND/OR -

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use -------

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1
Daniel Kline by UKM

CONFIDENTIAL

Division Sien Division of Surgical, Orthopedic, and Restorative Devices

. Page 15 of 52

510(k) Number K111564

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.