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

Device Description

The Su-Por® 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 Su-Por® Surgical Implants is high-density polvethylene when molded into the implants becomes a porous high-density polyethylene. Polvethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the Su-Por® Surgical Implants allow for tissue in growth. The material used to manufacture the Su-Por® 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

Here's a summary of the device's acceptance criteria and the study that proves it meets them, based on the provided text:

Device: Su-Por® Surgical Implants

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Su-Por® Surgical Implants are established by demonstrating substantial equivalence to legally marketed predicate devices. This means that the Su-Por® implants must be as safe, as effective, and perform as well as or better than the predicate devices. The performance is assessed across several categories, including material properties, manufacturing processes, packaging, and biocompatibility.

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance (Su-Por® Surgical Implants)
Biocompatibility	Cytotoxicity	Passed (demonstrates substantial equivalence to predicate devices)
	ISO Systemic Toxicity	Passed (demonstrates substantial equivalence to predicate devices)
	ISO Intracutaneous Study	Passed (demonstrates substantial equivalence to predicate devices)
	USP Pyrogen Study	Passed (demonstrates substantial equivalence to predicate devices)
	ISO Muscle Implantation Study	Passed (demonstrates substantial equivalence to predicate devices)
Sterility	Sterilization Validation (Ethylene Oxide - EtO)	Completed sterilization validation, demonstrating they are sterile devices for implantation, equivalent to predicate devices.
Mechanical Properties	Impact Testing	Completed. (Implies performance similar to predicate devices, contributing to substantial equivalence.)
	Flexural Testing	Completed. (Implies performance similar to predicate devices, contributing to substantial equivalence.)
	Tensile Strength Testing	Completed. (Implies performance similar to predicate devices, contributing to substantial equivalence.)
Material Purity	Purity Testing per USP	Completed. (Implies performance similar to predicate devices, contributing to substantial equivalence.)
Material Structure	Porosity Testing	Completed. (Implies comparable porous structure to predicate devices, allowing for tissue ingrowth as intended.)
Overall Equivalence	Intended Use & Indications for Use	Same as predicate devices.
	Technological Characteristics & Principles of Operation	Same as predicate devices.
	Raw Materials, Manufacturing Processes, Packaging	Same as predicate devices.

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

The document does not explicitly state a "test set" in the context of a statistical study with a specific sample size. Instead, the evaluation focuses on bench testing and biocompatibility testing of the Su-Por® Surgical Implants themselves.

Sample Size for Testing: Not specified as a number of "cases" or "patients." The testing involved samples of the device material and manufactured implants for various physical, chemical, and biological assessments.
Data Provenance: The document does not specify the country of origin for the data or if it was retrospective or prospective. It describes laboratory and material testing.

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

This type of information (number of experts, qualifications, etc.) is typically associated with clinical studies or evaluations where human assessment of medical images or conditions defines the ground truth. This document describes the premarket notification (510(k)) process for a medical implant, which primarily relies on bench testing and established material science standards to demonstrate substantial equivalence to existing devices.

Therefore, there is no mention of experts establishing ground truth in this context, as it's not a diagnostic AI device or a clinical outcome study requiring such a setup.

4. Adjudication Method for the Test Set

As there is no "test set" in the sense of clinical cases requiring expert adjudication, no adjudication method is mentioned or applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI algorithms when used by human readers (e.g., radiologists, pathologists) for diagnostic tasks. The Su-Por® Surgical Implant is a physical implant, not a diagnostic tool or an AI-assisted interpretation system.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This is not an AI device. The evaluation is for a physical medical implant.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on established material science standards, biocompatibility regulations, and predefined physical/chemical properties that define the safety and performance of porous polyethylene implants. The "truth" is whether the material and finished device meet these engineering and biological specifications, and whether they are comparable to predicate devices with a history of safe and effective use.

Bench Test Results: Passing criteria for impact, flexural, tensile strength, purity, and porosity.
Biocompatibility Standards: Meeting ISO and USP standards for cytotoxicity, systemic toxicity, intracutaneous reaction, pyrogenicity, and muscle implantation.
Sterilization Validation: Demonstrated sterility via Ethylene Oxide (EtO).

8. The Sample Size for the Training Set

This concept is not applicable here. There is no AI algorithm being "trained." The Su-Por® Surgical Implant is a manufactured device.

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

This concept is not applicable here, as there is no training set for an AI algorithm.

Summary

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Poriferous, .LLC

Office: 770-683-3855 Fax: 770-683-7459

K140437

Page 1 of 4

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: Poriferous, LLC 535 Pine Road, Suite 206, Newnan Georgia, 30263-7640 Phone: (770) 683-3855 Fax: (770) 683-7459
Contact Person: Aaron Noble, President/CEO Poriferous, LLC, Inc
Date Prepared: January 10th 2014

Device Name and Classification:

Trade/Proprietary Name:	Su-Por® Surgical Implants
Common Name:	Porous HD Polyethylene (HDPE) Implants
Classification Name:	Ear, Nose, and throat synthetic polymer material.
Class:	II
Regulation:	21 CFR 878.3500,
Product Code:	KKY
SubsequentProduct Code	FWP

Legally Marketed Predicate Devices:

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

Matrix Surgical USA OmniPor® Surgical Implants -- 510(k) #K123908

REV C 06/13/2014

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Poriferous, .LLC	K140437
Office: 770-683-3855 Fax: 770-683-7459	Page 2 of 4
、「アイドリア」と、「アイドライブ」(1)、1、1、1年(10月))(1月1日:1月1日:10月1日:10月1日:10月1日:10月1日:10月(1)、1971年)10月(1

Device Description:

The raw material used for the Su-Por® Surgical Implants is high-density polvethylene when molded into the implants becomes a porous high-density polyethylene. Polvethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the Su-Por® Surgical Implants allow for tissue in growth. The material used to manufacture the Su-Por® 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.

Indications for Use:

Similarities and Differences to the Predicate Devices:

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

The following table provides a comparison of the proposed device, and the predicate devices;

Device Name	Proposed Device	Predicate #1	Predicate #2
	Su-Por® SurgicalImplants; Preformedblock, sheet, andanatomical shapes.	MEDPOR®Surgical ImplantMaterial; PreformedCranial & FacialImplants	OmniPor® SurgicalImplants; Preformedblock, sheet, andanatomical shapes.
510(k) NumberIntended Use	This SubmissionSu-Por® SurgicalImplants in block, sheet,and anatomical shapesare intended for non-	K922489For augmentationor restoration bonycontour incraniofacial	K123908OmniPor® SurgicalImplants in block,sheet, and anatomicalshapes are intended for

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Poriferous, .LLC

Office: 770-683-3855 Fax: 770-683-7459

K140437 Page 3 of 4

	weight bearingapplications ofcraniofacialreconstruction/cosmeticsurgery and repair ofcraniofacial trauma. Su-Por® Surgical Implantsare also intended for theaugmentation orrestoration of contour inthe craniomaxillofacialskeleton.	defects.	nonweight bearingapplications ofcraniofacialreconstruction/cosmeticsurgery and repair ofcraniofacial trauma.OmniPore SurgicalImplants are alsointended for theaugmentation orrestoration of contour inthe craniomaxillofacialskeleton.
Material	A linear, high-densitypolyethylene biomaterial	A linear, high-densitypolyethylenebiomaterial	A linear, high-densitypolyethylenebiomaterial
Design	Preformed shapesincluding sheets, blocks,spheres, andanatomical shapes.	Preformed shapesincluding sheets,blocks, spheres,and anatomicalshapes.	Various shapes andsizes for differing areasof the craniofacialskeleton.
Sterile / Non-Sterile	Sterile	Sterile	Sterile
SterilizationMethod	EtO	EtO	EtO
Packaging	Double Tyvek Pouch	Double TyvekPouch	Double Tyvek Pouch
Biocompatible	Yes	Yes	Yes
Reusable	No	No	No

Summary of Testing:

The Su-Por Surqical 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 Su-Por Surgical Implants completed sterilization validate that that they are sterile devices for implantation as equivalent to the predicate devices. The Su-Por Surgical Implants completed mechanical testing specific to impact testing, flexural testing, tensile strength testing, purity testing per USP, and porosity testing.

The testing listed above assures the device is safe and effective for its intended use.

Substantial Equivalence Conclusions:

The Su-Por® Surgical Implants have the same intended use and indications for use, and the same technological characteristics and principles of operation as

REV C 06/13/2014

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Poriferous, .LLC	K140437
Office: 770-683-3855 Fax: 770-683-7459	Page 4 of 4

the predicate devices. It is concluded that the proposed device is substantially equivalent, based on the nonclinical testing (discussed above) that demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings outstretched, symbolizing care and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is rendered in black and white.

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

Poriferous, LLC Mr. Aaron Noble President/Chief Executive Officer 535 Pine Road. Suite 206 Newnan, Georgia 30263

June 13, 2014

Re: K140437

Trade/Device Name: Su-Por Surgical Implant Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: Class II Product Code: KKY, FWP Dated: May 12, 2014 Received: May 16, 2014

Dear Mr. Noble:

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. Ilisting 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. Aaron Noble

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,

Neil R Ogden -S 2014.06.13 13:53:53 -04'00'

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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Statement of Indications for Use

Applicant: Poriferous, LLC.

510(k) Number (if known): K140437

Device Name: Su-Por Surgical Implant

Indications for Use:

Su-Por Surgical Implants in block, sheet, and anatomical shapes are intended for non-weight bearing applications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. Su-Por Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter L. Hudson -S

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.