Medeor™ Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to: defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; urogynecological reinforcement (excluding transvaginal repair of pelvic organ prolaps) including but not limited to, rectal prolapse (excluding rectocele) using an abdominal approach, vaginal prolapse (excluding transvaginal repair of pelvic organ prolapse), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), hemia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications, and for reinforcement of the soft tissues, which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.

Medeor 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 bone, provide biomechanical strength for the tendon repair.

Medeor Matrix is intended for one time use.

Device Description

Medeor™ Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues. The device is supplied sterile in double-layer peel-open packages. The product is either packaged dry (lyophilized) to be hydrated prior to use, or can be supplied prehydrated, packaged and sterilized in saline.

AI/ML Overview

This document describes the performance data for the Medeor Matrix, a surgical mesh, in support of its 510(k) submission. However, it does not describe an AI/ML device or studies typically associated with such devices (e.g., comparative effectiveness studies with human readers, standalone algorithm performance, or ground truth establishment relevant to AI models). Therefore, I cannot extract information related to AI/ML device performance or study design for an AI/ML model from this document.

The document focuses on the traditional regulatory submission requirements for a medical device (surgical mesh), including mechanical testing and biocompatibility studies.

Let's break down what is available in the document regarding its performance criteria and studies for the Medeor Matrix surgical mesh:

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

The document doesn't provide a formal table of acceptance criteria with numerical targets. Instead, it states that the device "passed the requirements of all tests" for biocompatibility and "demonstrated equivalence of the device to legally cleared predicate devices" for mechanical testing.

Acceptance Criteria Category	Reported Device Performance
Mechanical Testing	Demonstrated equivalence to legally cleared predicate devices for Tensile Testing and Suture Retention.
Biocompatibility Testing	Passed the requirements of all tests conducted per ISO 10993-1:2003, including Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity, and Hemolysis.
In Vivo Studies	Results not explicitly detailed as "acceptance criteria met," but implies successful outcomes for defect repair in a sheep model and tissue reactions in a rabbit study.

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

Mechanical Testing: Sample sizes are not specified for Tensile Testing and Suture Retention.
Biocompatibility Testing: Sample sizes are not specified.
In Vivo Studies:
- Sheep model: "defects were repaired and evaluated in a sheep model." Sample size not specified.
- Rabbit study: "a rabbit study was performed to evaluate tissue reactions." Sample size not specified.
- Data Provenance: Not specified within the provided text.

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)

This information is not applicable as this document describes a physical medical device (surgical mesh) and its performance, not an AI/ML device requiring expert-established ground truth for a test set.

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

This information is not applicable as this document describes a physical medical device (surgical mesh) and its performance, not an AI/ML device adjudicated by 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

This information is not applicable. No MRMC study was conducted as this is not an AI/ML device.

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

This information is not applicable. This is not an AI/ML device; therefore, no standalone algorithm performance was assessed.

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

For mechanical testing, the "ground truth" would be the measured physical properties and their comparison to established standards or predicate devices. For biocompatibility, it's adherence to ISO 10993 standards and accepted biological response criteria. For in vivo studies, the "ground truth" would be histological analysis, gross observations, and clinical outcomes in the animal models.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

Summary

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510(k) Summary

Submitted by:	Kensey Nash Corporation dba DSM Biomedical735 Pennsylvania DriveExton, PA 19341
Contact Person:	Lori Burns, MS, RACManager Regulatory AffairsPh: (484) 713-2100Fax: (484) 713-2903
Date Prepared:510(K) #:	June 13, 2014K091499
Device:
Trade Name:	Medeor Matrix
Common/Usual Name:	Surgical Mesh
Proposed Classification:	21 CFR 878.3300FTM, OXH, OXE, OXB, OWY, PAJ

Class II

Device Description:

Predicate Devices:

Manufacturer	Device	510(k)#
Kensey Nash Corporation	BioBlanket™	K061030
Lifecell	Strattice™	K080353

Intended Use:

Medeor™ Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; urogynecological reinforcement (excluding transvaginal repair of pelvic organ prolapse) including but not limited to, rectal prolapse (excluding rectocele) using an abdominal approach, vaginal prolapse (excluding transvaginal repair of pelvic organ prolapse), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications, and for reinforcement of the soft tissues, which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.

Medeor 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.

Medeor Matrix is intended for one time use.

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Performance Data:

Mechanical testing performed with Medeor Matrix demonstrated equivalence of the device to legally cleared predicate devices. Mechanical test reports were completed for the following:

. Tensile Testing
Suture Retention .

The following biocompatibility tests were conducted on the finished device according to the requirements of ISO 10993-1:2003, Biological evaluation of medical devices - Part 1:Evaluation and testing: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemolysis.

The device was evaluated in two in vivo studies; defects were repaired and evaluated in a sheep model and a rabbit study was performed to evaluate tissue reactions.

Medeor Matrix passed the requirements of all tests.

Substantial Equivalence:

Performance Testing has confirmed that Medeor Matrix is substantially equivalent to the predicate devices with regard to materials, intended use and technological characteristics, pursuant to section 510(k).

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

June 16, 2014

Kensey Nash Corporation % Ms. Alyssa J. Schwarts, MS, RAC Regulatory Affairs Affairs 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K091499

Trade/Device Name: Medeor™ Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OXB, OXE, OXH, OWY, PAJ Dated: October 12, 2009 Received: October 13, 2009

Dear Ms. Schwarts:

This letter corrects our substantially equivalent letter of October 22, 2009.

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

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Page 2 - Ms. Alyssa J. Schwarts, MS. RAC

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) K091499

Device Name Medeor Matrix

Indications for Use (Describe)

Medeor Matrix is intended for one time use.

Type of Use (Select one or both, as applicable)

2 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 A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

I Krause

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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.