PROseries™ Bioimplants are 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.

PROseries Bioimplants are 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

PROseries Bioimplants are comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, derived from equine pericardial tissue, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (PROseries Bioimplants) and it explicitly states that the device is "substantially equivalent" to a predicate device. This type of submission relies on demonstrating similarity to an already approved device rather than presenting a de novo study with acceptance criteria and a detailed study proving those criteria were met in the way a clinical trial for a novel drug or a new AI diagnostic would.

Therefore, many of the requested sections (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of regulatory submission and information is not available in the provided document.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance

For a 510(k) submission based on substantial equivalence, the "acceptance criteria" are typically met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons across various attributes. Specific quantitative acceptance criteria for performance as in a clinical trial are generally not provided in this type of summary.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Design: Identical to predicate device	PROseries Bioimplants are identical to the predicate device in terms of design.
Technology: Identical to predicate device	PROseries Bioimplants are identical to the predicate device in terms of technology.
Intended Use: Identical to predicate device	PROseries Bioimplants are identical to the predicate device in terms of intended use. (See "Statement of Intended Use" for details).
Materials: Identical to predicate device	PROseries Bioimplants are identical to the predicate device in terms of materials. (Comprised of collagen matrix from equine pericardial tissue reinforced by a woven polymer).
Performance: Identical to predicate device	Biocompatibility testing, biomechanical bench testing, and in vivo performance testing have been conducted to evaluate the biological safety and biomechanical performance characteristics, demonstrating identity to predicate.
Processing Methods: Identical to predicate device	PROseries Bioimplants are identical to the predicate device in terms of processing methods.
Sterility: Meets USP sterility testing and FDA LAL endotoxin limits	The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device.

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

Not Applicable / Not provided. This information is typically relevant for studies designed to establish de novo safety and effectiveness, or for AI/diagnostic devices that require large datasets for validation. For a substantial equivalence claim based on physical device characteristics, this detailed information about "test sets" or "data provenance" in the context of clinical data is not expected in this summary. The "testing" referred to is laboratory and in vivo performance testing.

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 / Not provided. No ground truth established by experts in this manner is described as part of this submission, as it's not an AI or diagnostic device requiring such evaluation.

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

Not Applicable / Not provided. Not relevant for this type of device and submission.

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 / Not provided. This is a physical surgical mesh, not an AI-assisted diagnostic or imaging device.

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

Not Applicable / Not provided. This is a physical surgical mesh, not an algorithm.

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

Not Applicable / Not provided. The "truth" for this device revolves around its physical, chemical, and biological properties (biocompatibility, biomechanical strength, sterility) matching the predicate device and meeting relevant standards. It's not about diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

Not Applicable / Not provided. This device is not an AI model, so there is no concept of a "training set."

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

Not Applicable / Not provided. As there is no training set, this question is not applicable.

Summary

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510(K) SUMMARY

K112786
OCT 25 2011

Submitter Information 1

A.	Company Name:	Synovis Orthopedic and Woundcare, Inc.
B.	Company Address:	6 Jenner, Suite 150Irvine, CA 92618
C.	Company Phone:	(949) 502-3240
D.	Company Facsimile:	(949) 502-3241
E.	Contact Person:	Amy BouclyManager, Regulatory Affairs
F.	Date:	October 17, 2011
Device Identification
A.	Device Trade Name:	PROseriesTM Bioimplants-PROcuffTM/PROankleTM
B.	Models:	PROcuffTM, PROankleTM, PROxxx (TBD)
C.	Common Name:	Surgical Mesh
D.	Classification Name(s):	Mesh, Surgical
E.	Classification Regulation:	878.3300
F.	Device Class:	Class II
G.	Device Code(s):	FTM, FTL
H.	Advisory Panel:	General and Plastic Surgery

3 Identification of Predicate Device

The PROseries™ Bioimplants – PROcuff™/PROankle™ are substantially equivalent to the OrthADAPT® PR Bioimplant, Pegasus Biologics, Inc., K090288.

4 Device Description

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5 Statement of Intended Use

Biocompatibility and Performance Data 6

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

7 Comparison with Predicate Devices

The PROseries Bioimplants are identical to the predicate device in terms of design, technology, intended use, materials, performance and processing methods.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

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

Synovis Orthopedic and Woundcare, Inc. % Ms. Amy Boucly Manager, Regulatory Affairs 6 Jenner Street, Suite 150 Irvine, California 92618

OCT 2 5 2011

Re: K112786

Trade/Device Name: PROseries Bioimplants – PROcuff"/PROankle"* Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM, FTL Dated: September 23, 2011 Received: September 27, 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

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Page 2 - Ms. Amy Boucly

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 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/ReportalProblem/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,

For No. 10.11.20

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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Indications for Use

510(k) Number (if known): K112786

Device Name:

PROseries Bioimplants - PROcuff /PROankle

Indications For Use:

The device is also intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

Dail Kucie for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112786

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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.