Synergy™ Tissue Matrix is intended to be used for implantation to reinforce 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.

The device 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,

Synergy Tissue Matrix 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.

Device Description

Synergy Tissue Matrix is an implantable biologic mesh comprised of non-crosslinked bovine pericardium. Synergy Tissue Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Synergy™ Tissue Matrix, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Biocompatibility	ISO 10993-1 compliance	Acceptable and equivalent to predicate devices.
	Viral inactivation	Satisfactory results (implied by overall biocompatibility).
	Pyrogen testing	Satisfactory results (implied by overall biocompatibility).
	Residual chemicals assessment	Satisfactory results (implied by overall biocompatibility).
Biomechanical Performance	Tensile strength	Equivalent to predicate devices and satisfies mechanical performance requirements for intended use.
	Burst strength	Equivalent to predicate devices and satisfies mechanical performance requirements for intended use.
	Suture pull-out strength	Equivalent to predicate devices and satisfies mechanical performance requirements for intended use.
Physical/Chemical/Structural Characterization	(General characterization)	Comparable to predicate devices.
In Vivo Performance	Tissue response/functionality	Normal tissue healing response and confirms remodeling capability.
Substantial Equivalence	Materials	Equivalent to Veritas and PROPatch.
	Physical characteristics	Equivalent to Veritas and PROPatch.
	Performance characteristics	Equivalent to Veritas and PROPatch.
	Biological attributes	Equivalent to Veritas and PROPatch.
	Indications for Use	Substantially equivalent to OrthADAPT, PROPatch, and CuffPatch (with specific exclusions).

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

The document does not specify a distinct "test set" in the context of clinical studies with human subjects or a defined dataset for AI evaluation. The evaluations are primarily based on:

Bench Testing: Mechanical properties (tensile strength, burst strength, suture pull-out) would involve samples of the device itself. No specific sample sizes are mentioned.
Animal Implant Studies: These are in vivo (live animal) studies. The number of animals used is not specified.
Biocompatibility Testing: Conducted in vitro (laboratory) or in vivo (animal) according to ISO 10993-1. Specific sample sizes are not provided.
The provenance of the data is not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical/laboratory-based and animal studies, not human clinical trials. They are likely prospective for the specific tests performed on the Synergy™ Tissue Matrix.

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

Not applicable. This device is a surgical mesh; the ground truth for its performance is established through objective physical, chemical, and biological testing as well as animal studies, not through expert consensus on interpreting data (like images).

4. Adjudication Method for the Test Set

Not applicable, as the evaluation methods are objective measurements and animal observations, rather than interpretation by multiple experts.

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 medical device (surgical mesh), not an AI/software-as-a-medical-device (SaMD) that involves human readers or AI assistance.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

Objective measurement standards: For biocompatibility (e.g., ISO 10993-1), pyrogenicity, residual chemicals.
Engineered performance metrics: For biomechanical properties (tensile strength, burst strength, suture pull-out).
Histopathological and physiological observations: From animal implant studies (normal tissue healing, remodeling capability).
Chemical and physical characterization: Material composition, structure, etc.

These are established by recognized scientific and engineering principles and standards, not expert consensus on ambiguous data.

8. The Sample Size for the Training Set

Not applicable. This type of device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no "training set" for this device.

Summary

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K113460 page 1/2 JAN 11 2012
510(K) SUMMARY
1 Submitter Information

A. Company Name:	Synovis Orthopedic and Woundcare, Inc.
B. Company Address:	6 Jenner, Suite 150 Irvine, CA 92618
C. Company Phone:	(949) 502-3240
D. Company Facsimile:	(949) 502-3241
E. Contact Person:	Amy Boucly Manager, Regulatory Affairs/Quality Assurance
F. Date:	01/04/12

2 Device Identification

A. Device Trade Name:	Synergy™ Tissue Matrix
B. Common Name:	Surgical Mesh
C. Classification Name(s):	Mesh, Surgical
D. Classification Regulation:	878.3300
E. Device Class:	Class II
F. Device Code(s):	FTM
G. Advisory Panel:	General and Plastic Surgery

3 Identification of Predicate Devices### Identification of Predicate Devices 3

Synergy Tissue Matrix is substantially equivalent to the following surgical mesh devices, which are cleared for commercial distribution in the United States:

OrthADAPT® Bioimplant, Pegasus Biologics, Inc., K043388, K071065 .
Veritas® Collagen Matrix, Synovis Surgical Innovations, K002233, K030879, ● K062915
CuffPatch® Surgical Mesh, Organogenesis, Inc. K042809 .
PROPatch® Soft Tissue Repair Matrix, CryoLife, Inc., K061892, K101587 .

4 Device Description

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5 Statement of Intended Use

Synergy is intended to be used for implantation to reinforce 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.

Synergy 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.

6 Biocompatibility and Performance Data

Biocompatibility testing, biomechanical bench testing, characterization testing and in vivo performance testing have been conducted to evaluate the biological safety and biomechanical performance characteristics of Synergy.

Biocompatibility testing was performed in accordance with ISO 10993-1 (Biological Evaluation of medical devices - Part 1: Evaluation and testing within a risk management process). Other safety testing included a viral inactivation study, pyrogen testing and residual chemicals assessment. Results indicate that the device biocompatibility profile is acceptable and equivalent to the predicate devices.

Biomechanical testing, including tensile strength, burst strength and suture pull-out strength was performed and results indicate that the device is equivalent to the predicate devices and satisfies mechanical performance requirements for its intended use. Additionally, results of physical, chemical and structural characterization testing indicate that the device is comparable to predicate devices.

Animal implant studies were performed to confirm the functionality and tissue response characteristics of the Synergy Tissue Matrix. Results indicate a normal tissue healing response and confirm the subject device's remodeling capability.

7 Comparison with Predicate Devices

The Synergy Tissue Matrix is equivalent to Veritas and PROPatch with respect to materials, physical and performance characteristics and biological attributes. It is also substantially equivalent to the OrthADAPT, PROPatch and CuffPatch in indications for use and physical, chemical and biomechanical characteristics.

Indications for use do not include urinary incontinence, rectal or vaginal prolapse, or other pelvic floor surgery.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black-and-white design, and the text is in a sans-serif font.

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

JAN 1 1 2012

Synovis Orthopaedic and Woundcare, Incorporated % Ms. Amy Boucly Manager, Regulatory Affairs/Quality Assurance 6 Jenner. Suite 150 Irvine, California 92618

Re: K113460

Trade/Device Name: Synergy™ Tissue Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: November 18, 2011 Received: November 22, 2011

Dear Ms. Boucly:

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. 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 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

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Page 2 - Ms. Amy Boucly

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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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૨૦ા

Indications for Use

510(k) Number (if known):

K113460

Device Name:

Synergy™ Tissue Matrix

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number.	K113460
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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.