ProPatch™ Soft Tissue Repair Matrix is indication to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floration of the reinforcement, and reconstructive procedures.

ProPatch™ Soft Tissue Repair Matiz is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendone repair surgery including reinforcement of solt used as them soft includes, biceps, quadriceps, or other tendons.

ProPatch™ Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendor to 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. ProPatch™ Soft Tissue Repair Matrix reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

Device Description

ProPatch™ Soft Tissue Repair Matrix is an acelluar bovine pericardia based surgical mesh. Product configurations consist of a 7 cm round and a 5 x 8 cm oval shapes, and configurations from 1 x 1 cm to 9 x 19 cm. Each surgical mesh is packaged ready to use within a clear peel-away inter pouch, and a foil laminte peelaway outer pouch. The packaged product is supplied sterile and non-pyrogenic.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ProPatch™ Soft Tissue Repair Matrix. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial with acceptance criteria for device performance in the way an AI/ML device would. Therefore, much of the requested information (like expert qualifications, adjudication methods, MRMC studies, sample sizes for training/test sets, and ground truth establishment for AI/ML models) is not applicable to this submission.

However, I can extract information related to the device's physical performance and biocompatibility testing which serves a similar role to "acceptance criteria" for a medical device that reinforces soft tissues.

Here's a summary of the available information:

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

Acceptance Criteria Category	Reported Device Performance
Mechanical/Biomechanical	Demonstrates acceptable tensile strength, stiffness, tear resistance, suture retention strength, and burst strength. (Specific quantitative values are not provided in the summary, but the results were deemed "acceptable" in accordance with guidance document.)
Biocompatibility	Suitable biocompatibility. Intramuscular implants of the device were found to be non-irritating relative to the control article. (Specific quantitative values or detailed biocompatibility test results are not provided beyond the non-irritating finding.)

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

Test Set Sample Size: Not explicitly stated as this is a device for physical reinforcement, not an AI/ML diagnostic. The testing involved mechanical and biocompatibility assessments, which would have their own sample sizes (e.g., number of samples for tensile testing, number of animals for biocompatibility). These are not detailed in the summary.
Data Provenance: Not applicable in the context of country of origin for patient data. The provenance relates to laboratory testing of the material.

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

Not Applicable. Ground truth, in the AI/ML sense, is not relevant here. The "ground truth" for this device is established by physical measurement standards and established biocompatibility testing protocols, not by expert interpretation of patient data.

4. Adjudication method for the test set:

Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of data, which is not the nature of this submission. The tests performed are objective physical and chemical tests.

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/ML diagnostic or assistance tool; therefore, MRMC studies are irrelevant.

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:

For Mechanical/Biomechanical performance: The "ground truth" is based on established engineering principles and standards for material strength, stiffness, tear resistance, suture retention, and burst strength. The compliance is assessed against the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (revision: 03/02/1999)."
For Biocompatibility: The "ground truth" is based on established biological safety principles and testing protocols (e.g., ISO 10993 series), specifically stating "Intramuscular implants of the device were found to be non-irritating relative to the product control article."

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Not Applicable. This is not an AI/ML device.

Summary

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NOV 2 2 2006

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92.

Submitter:	CryoLife, Inc.1655 Roberts Blvd., NWKennesaw, GA 30144(770) 419-3355	Contact Person:
Device Names:	Device Trade Name:	ProPatch™ Soft Tissue Repair Matrix
	Common/Usual Name:	Surgical Mesh
	Proposed Classification Name:	Surgical Mesh (Product Code: FTM)

Intended Use:

Predicate Devices:

Device	Company	510 (k) Number(s),Clearance Date	ProductCode
OrthADAPTTMBioimplant	Pegasus Biologics6 Jenner, Suite 150Irvine, CA 92618	K043388 – 08/05/2005	FTM
Restore® OrthobiologicSoft Tissue Implant	Depuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581	K031969 – 07/28/2003K001738 – 12/27/2000K982330 – 09/25/1998	FTM

Device Description:

Testing Supporting Substantial Equivalence:

Tissue biomechanics and functional performance testing of ProPatch™ was performed in accordance with the Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (revision: 03/02/1999). Results these tests demonstrate that the product has acceptable tensile strength, stiffines, tear resistance, suture retention strength, and burst and in Diocompatibility testing was performed to meet the Intropies include of the device users at ingl. Drocontinent and support suitable biocompatibility of the product Intramuscular implants of the device were found to be non-irritating relative to the producte control article.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

June 16, 2014

CryoLife, Inc. % Mr. John D. Ferros Manager, Regulatory Affairs 1655 Roberts Boulevard Northwest Kennesaw, Georgia 30144

Re: K061892

Trade/Device Name: ProPatch™ Soft Tissue Repair Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXB, OXE, OXH, OWY Dated: October 12, 2006 Received: October 13, 2006

Dear Mr. Ferros:

This letter corrects our substantially equivalent letter of November 22, 2006.

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. Iisting 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

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Page 2 - Mr. John D. Ferros

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/ResourcesforYou/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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Indications for Use

510(k) Number (if known): K061892

Device Name: ProPatch Soft Tissue Repair Matrix

Indications for Use:

ProPatch Soft Tissue Repair Matrix is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures.

ProPatch Soft Tissue Repair Matrix is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

ProPatch Soft Tissue Repair 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. ProPatch Soft Tissue Repair Matrix reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause -S

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.