OmniPore® Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

Device Description

The OmniPore® Surgical Implants are marketed as single use sterile implants with various shapes and sizes for different areas of the craniofacial skeleton. The applications include non-load bearing augmentation and/or reconstruction of the craniofacial skeleton.

The raw material used for the OmniPore® Surgical Implants is high-density polyethylene when molded into the implants becomes a porous high-density polyethylene. Polyethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the OmniPore® Surgical Implants allow for tissue in growth. Additionally, Animal histology has shown fibrovascular ingowth occurs into the open pore structure of OmniPore Surgical Implants. The material used to manufacture the OmniPore® Surgical Implants has been utilized in reconstruction and soft tissue repair for many years. There is a long history of the use of porous polyethylene implants for enucleation and evisceration, as well as for many applications in craniofacial reconstruction and augmentation, with a history of safety and performance.

The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.

AI/ML Overview

The provided text describes a 510(k) submission for the OmniPore® Surgical Implants. This is a medical device application for market clearance in the United States, based on substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in the way a clinical trial would.

Therefore, the requested information elements related to clinical study design, such as sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training sets, are not applicable to this type of submission. The submission focuses on demonstrating equivalency of materials, manufacturing processes, and performance characteristics to a legally marketed predicate device.

Here's a breakdown of the available information in the context of your request:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance (Summary)
Material Biocompatibility	Cytotoxicity Testing	Substantially equivalent materials as predicate devices.
	ISO Systemic Toxicity	Substantially equivalent materials as predicate devices.
	ISO Intracutaneous Study	Substantially equivalent materials as predicate devices.
	USP Pyrogen Study	Substantially equivalent materials as predicate devices.
	ISO Muscle Implantation Study	Substantially equivalent materials as predicate devices.
Sterilization Validation	Sterilization Validation	Validated to be sterile devices for implantation, equivalent to predicate devices.
Mechanical Performance	Impact Testing	Completed, results support substantial equivalence.
Material Purity	Purity Testing per USP	Completed, results support substantial equivalence.
Material Porosity	Porosity Testing	Completed, results support substantial equivalence.

Study Proving Acceptance Criteria:

The "study" in this context is the collection of tests performed to demonstrate substantial equivalence to the predicate device, not necessarily to meet pre-defined numeric performance thresholds for clinical outcomes. The manufacturer states:

"The OmniPore® Surgical Implants were tested to the biocompatibility standards to demonstrate that they are substantially equivalent materials as the predicate devices in regards to Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous Study, USP Pyrogen Study, and ISO Muscle Implantation Study."
"The OmniPore® Surgical Implants completed sterilization validation to validate that they are sterile devices for implantation as equivalent to the predicate devices."
"The OmniPore® Surgical Implants completed mechanical testing specific to impact testing, purity testing per USP, and porosity testing."
"Testing results support the determination of substantial equivalence with the results demonstrating that the OmniPore Surgical Implants have equivalent results as the predicate devices."

The regulatory decision (K123908) from the FDA indicates that the device was found substantially equivalent to legally marketed predicate devices, meaning it has the same intended use, indications for use, and technological characteristics, and any minor differences do not raise new questions of safety or effectiveness.

Non-Applicable Information for a 510(k) Submission of this Nature:

Sample size used for the test set and the data provenance: Not described for clinical performance, as this is a substantial equivalence submission based on material and mechanical testing, not a clinical study. The "test set" here refers to the samples of the implant material subjected to the various physical and chemical tests listed above. No human or patient data is mentioned in relation to proving performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in a clinical sense, is not established for material characterization and mechanical testing. The "experts" are the lab technicians and scientists conducting the standardized biocompatibility, sterilization, and mechanical tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to material and mechanical testing.
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 implant, not an AI/software device involving human readers or interpretation of medical images.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the clinical sense. For the material properties, the "ground truth" is defined by established international standards (e.g., ISO, USP) for biocompatibility, sterility, and material characteristics.
The sample size for the training set: Not applicable. This is a physical implant, not an AI/machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

K123908

10f2

Matrix Surgical USA Traditional 510(k) - OmniPore® Surgical Implants

JUL 3 1 2013

510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.

Submitted By:	Matrix Surgical USA575 Pharr Rd NW #550873Atlanta, GA 30305Phone: (404) 862-3794Fax: (404) 869-8208
Contact Person:	Julie Stephens, President/Consultant

Date Submitted: July 26, 2013

Device Name and Classification:

Trade/Proprietary Name:	OmniPore® Surgical Implants
Common Name:	Porous HD Polyethylene (HDPE) Implants
Classification Name:	Material, porous polymer, for maxillofacial reconstruction
Class:	II
Regulation:	21 CFR 878.3500
Product Code:	KKY

Requlatory Resources Group, Inc.

Legally Marketed Predicate Devices:

POREX Surgical Inc. (now owned by Stryker® Craniomaxillofacial) - MEDPOR® Surgical Implant Material: Preformed Cranial and Facial Implants - 510(k) # K922489

Device Description:

The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.

{1}------------------------------------------------

Matrix Surgical USA Traditional 510(k) - OmniPore® Surgical Implants

510(k) SUMMARY

Indications for Use:

Similarities and Differences to the Predicate Devices:

Similarities

The same raw materials, manufacturing processes, packaging materials, performance standards, and the same indications for use are used in the OmniPore and the predicate devices.

Differences

There are slight differences in the OmniPore when compared against the predicates specific to manufacturing facility locations.

Summary of Testing:

The OmniPore Surgical Implants were tested to the biocompatibility standards to demonstrate that they are substantially equivalent materials as the predicate devices in regards to Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous Study, USP Pyrogen Study, and ISO Muscle Implantation Study. The OmniPore Surgical Implants completed sterilization validation to validate that they are sterile devices for implantation as equivalent to the predicate devices. The OmniPore Surgical Implants completed mechanical testing specific to impact testing, purity testing per USP, and porosity testing.

Substantial Equivalence Conclusions:

The OmniPore® Surgical Implants have the same intended use and indications for use, and the same technological characteristics and principles of operation as the predicate devices. The minor differences do not raise any issues of safety or effectiveness. Testing results support the determination of substantial equivalence with the results demonstrating that the OmniPore Surgical Implants have equivalent results as the predicate devices.

{2}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 31, 2013

Matrix Surgical USA % Ms. Julie Stephens President/Consultant 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K123908

Trade/Device Name: OmniPore® Surgical Implants Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: Class II Product Code: KKY Dated: July 1, 2013 Received: July 1, 2013

Dear Ms. Stephens:

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

{3}------------------------------------------------

Page 2 - Ms. Julie Stephens

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K123908

Device Name: OmniPore® Surgical Implants and Accessories

Indications for Use:

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)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123908

Page 1 of 1

Regulation Number and Section

§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.

(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.