OmniPore® Customized Surgical Implants are intended for non-weight bearing applications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. OmniPore Customized Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

Device Description

The OmniPore® Customized Surgical Implants are marketed as single patient use sterile implants that physicians request as customized surgical implants which use identical materials and manufacturing to the OmniPore® Surgical Implants but are made to a predetermined patient's measurements and size requirements. The applications include non-load bearing augmentation and/or reconstruction of the craniofacial skeleton. The OmniPore Customized Surgical Implants are created from the patient's CT imaging data provided from the physician. The OmniPore Customized Surgical Implants are manufactured from the same material, manufactured under the same processes, and packaged the same as the OmniPore Surgical Implants.

The raw material used for the OmniPore Customized Surgical Implants is high-density polyethylene resin which has a long history of use in surgical implantable products. The interconnecting open pore structure of the OmniPore Customized Surgical Implants allow for tissue in-growth. Additionally, animal histology has shown fibrovascular in-growth occurs into the open pore structure of OmniPore Customized Surgical Implants.

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

AI/ML Overview

This document describes the OmniPore® Customized Surgical Implants, a device intended for non-weight-bearing applications in craniofacial reconstruction/cosmetic surgery, repair of craniofacial trauma, and augmentation/restoration of contour in the craniomaxillofacial skeleton.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantifiable acceptance criteria for the device's performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that the device performs equivalently to its predicates across various aspects.

Acceptance Criteria Category	Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance
Material Equivalence	Not explicitly stated as a quantitative criterion, but implicit expectation is the materials are identical or perform equivalently to predicate devices.	"The OmniPore® Customized Surgical Implant materials are equivalent materials as the previously cleared OmniPore Surgical Implant devices..."
Biocompatibility	Not explicitly stated as a quantitative criterion, but implicit expectation is the device is biocompatible as demonstrated by predicate testing.	"...so the biocompatibility and sterilization validation to validate that they are sterile devices for implantation was justified from the predicate testing." (Performance is inferred to be adequate based on predicate.)
Sterilization Efficacy	Not explicitly stated as a quantitative criterion, but implicit expectation is terminal sterilization is effective (e.g., Sterility Assurance Level of 10^-6).	"...so the biocompatibility and sterilization validation to validate that they are sterile devices for implantation was justified from the predicate testing." (Performance is inferred to be adequate based on predicate.) The implants are "provided sterile by ethylene oxide (EO) terminal sterilization."
Mechanical Properties (Impact, Purity, Porosity)	Not explicitly stated as a quantitative criterion, but implicit expectation is that these properties are equivalent to predicate devices.	"The OmniPore Customized Surgical Implants are equivalent materials as the previously cleared OmniPore Surgical Implant devices so the mechanical testing specific to impact testing, purity testing per USP, and porosity testing was justified from the OmniPore Surgical Implant device testing." (Performance is inferred to be adequate based on predicate.)
Software Verification (for Customization Process)	Not explicitly stated, but implicit expectation is that the software used for customized design is validated and functions equivalently to predicate.	"The software verification testing documentation for the OmniPore Customized Surgical Implants was provided to justify equivalence against the MEDPOR® Customized Surgical Implant." (Performance is inferred to be adequate based on predicate, indicating the software part of the device's manufacturing process has been verified.)
Clinical Performance / Safety and Effectiveness for Intended Use (Overall Substantial Equivalence)	No specific quantitative clinical endpoints or safety profiles are provided as acceptance criteria in this document.	"The OmniPore® Customized 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 Customized Surgical Implants have equivalent results as the predicate devices." (Summary conclusion of equivalence.)

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

The document does not specify a "test set" in the traditional sense of a clinical or retrospective study with patient data for evaluating the device's performance. The evaluation for this 510(k) submission is based on demonstrating equivalence to predicate devices, primarily through material and manufacturing equivalency, and justification from existing predicate testing data.

Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this type of submission which focuses on substantial equivalence rather than a de novo clinical study. The "testing" mentioned refers to justification based on previously conducted tests for predicate devices.

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

This information is not applicable as there is no mention of a clinical "test set" requiring expert ground truth establishment for patient outcomes or diagnoses. The submission relies on scientific and engineering evaluations for material equivalence and manufacturing processes.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a "test set" requiring adjudication.

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. The device described is a physical surgical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

This information is not applicable. The device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used

Given the nature of the submission (demonstrating substantial equivalence for a physical implant), the "ground truth" is largely:

Material properties and manufacturing process specifications: Confirming the raw materials, manufacturing methods, and sterilization processes are the same or equivalent to the predicate devices.
Existing predicate device performance data: Relying on the established safety and effectiveness of the legally marketed predicate devices through their prior biocompatibility, sterilization validation, and mechanical testing results.
Software verification documentation: For the customization process, ensuring the software performs its intended function for creating the customized implant based on CT data, likely verified against functional requirements and possibly accuracy checks against reference CAD models or similar.

There is no mention of pathology, expert consensus on patient outcomes from a new study, or specific outcomes data for the OmniPore® Customized Surgical Implants itself beyond the predicate justification.

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires a training set. The customization is based on patient-specific CT imaging data for manufacturing, not on a machine learning model trained on a dataset.

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

This information is not applicable for the same reason as point 8.

Summary

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

May 14, 2014

Matrix Surgical Holdings, LLC/Matrix Surgical USA % Regulatory Resources Group, Inc. Julie Stephens 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K133046

Trade/Device Name: OmniPore® Customized Surgical Implants Regulation Number: 21 CFR 878.3500 Regulatory Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: Class II Product Code: KKY Dated: April 08, 2014 Received: April 09, 2014

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

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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/Resourcesfor You/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 Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
cc: DMC 510(k) Staff Division D.O.

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Indications for Use

510(k) Number (if known):

Device Name: OmniPore® Customized Surgical Implants

Indications for Use:

X Prescription Use (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)

Peter E. Hudson -S

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

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 Holdings, LLC / Matrix Surgical USA575 14th Street, NWAtlanta, GA 30318Phone: (404) 862-3794Fax: (404) 869-8208
Contact Person:	Julie Stephens, President/ConsultantRegulatory Resources Group, Inc.

May 12, 2014 - Revised Date Submitted:

Device Name and Classification:

Trade/Proprietary Name:	OmniPore® Customized Surgical Implants
Common Name:	Surgical Implants, Cranial and Facial
Classification Name:	Polytetrafluoroethylene with carbon fiberscomposite implant material
Product Code:	KKY

Legally Marketed Predicate Device:

Matrix Surgical USA - OmniPore® Surgical Implants - 510(k) # K123908 POREX Surgical Inc. (now owned by Stryker® Craniomaxillofacial) - MEDPOR® Customized Surgical Implant - 510(k) # K083621

Device Description:

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

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

510(k) SUMMARY

Indications for Use:

Similarities and Differences to the Predicate Devices:

Similarities

The same raw materials, manufacturing processes, packaging materials, sterilization facilities, performance standards, and indications for use are used with the OmniPore Customized Surgical Implants as with the OmniPore Surgical Implants.

Differences

There are slight differences in the Omnized Surgical Implants when compared against the MEDPOR predicate specific to manufacturing and sterilization facility locations.

Summary of Testing:

The OmniPore® Customized Surgical Implant materials are equivalent materials as the previously cleared OmniPore Surgical Implant devices so the biocompatibility and sterilization validation to validate that they are sterile devices for implantation was justified from the predicate testing. The OmniPore Customized Surgical Implants are equivalent materials as the previously cleared OmniPore Surgical Implant devices so the mechanical testing specific to impact testing, purity testing per USP, and porosity testing was justified from the OmniPore Surgical Implant device testing. The software verification testing documentation for the OmniPore Customized Surgical Implants was provided to justify equivalence against the MEDPOR® Customized Surgical Implant.

Substantial Equivalence Conclusions:

The OmniPore® Customized 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 anv issues of safety or effectiveness. Testing results support the determination of substantial equivalence with the results demonstrating that the OmniPore Customized Surgical Implants have equivalent results as the predicate devices.

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.