The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.

Device Description

MEDPOR CONTAIN Implant is a thin, highly porous, biocompatible semi-rigid sheet, made from the same biocompatible pure porous high-density polyethylene (pHDPE) material which allows for host tissue integration as other MEDPOR Surgical Implants. The MEDPOR CONTAIN Implant is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.

AI/ML Overview

The provided document is a 510(k) summary for the MEDPOR® CONTAIN™ Implant. It describes the device, its intended use, technological characteristics, and compares it to predicate devices to establish substantial equivalence.

Crucially, this document is a premarket notification for a medical device and does not contain a study or data proving the device meets acceptance criteria. Instead, it is a submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, and raises no new questions of safety or effectiveness.

Therefore, many of the requested sections, such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, and details of comparative effectiveness studies (MRMC or standalone), cannot be extracted from this document, as they are not present.

However, I can provide information based on what is available regarding the comparison to predicate devices, which is the basis for its clearance.

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

This document does not specify "acceptance criteria" in the typical sense of a performance study with numerical targets and results. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, material, design, sterilization, and biocompatibility.

The "reported device performance" in this context is implicitly the assertion that the MEDPOR CONTAIN Implant performs similarly to its predicates due to shared characteristics.

Category	Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (as described in the document)
Intended Use	Stabilize, support, and provide space maintenance for bone graft materials in maxilla, mandible, and zygoma.	The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible, and zygoma. (Matches predicate intended uses or sufficiently similar)
Material	Biocompatible, linear, high-density polyethylene.	A linear, high-density polyethylene biomaterial. (Same as Predicate #1)
Design/Form	Sheets of various sizes and thicknesses; trimmable/cuttable.	15mm x 30mm, 25mm x 30mm, 45mm x 30mm sheets in 0.25mm and 0.35mm thicknesses and other shapes and sizes, as well as patient specific customized shapes. Can be trimmed or cut to size and bent. (Similar to predicate forms)
Sterility	Sterile	Sterile
Sterilization Method	Appropriate and effective sterilization method.	EtO (Same as Predicate #1)
Biocompatibility	Biocompatible	Yes

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

Not applicable. This document is a 510(k) premarket notification based on substantial equivalence to existing predicate devices, not a clinical study report with a test set. There are no "test sets" or "data provenance" details for a performance study in this submission.

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

Not applicable. As no performance study with a test set is reported, there is no "ground truth" established by experts within this document. The assessment is regulatory by the FDA based on the submission.

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

Not applicable. No test set or performance data is presented, so no adjudication method is relevant here.

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. A MRMC comparative effectiveness study is not discussed. This device is a passive implant, not an AI-powered diagnostic tool.

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

Not applicable. This device is a medical implant, not an algorithm, so this type of study is not relevant.

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

Not applicable. No ground truth data from a performance study is utilized in this 510(k) summary. The "ground truth" for the FDA's decision is the established safety and effectiveness of the predicate devices to which the new device is compared.

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for a machine learning model, there is no associated ground truth establishment method.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for POREX Surgical Products Group. The word "POREX" is in large, bold, black letters. Below the word "POREX" is the phrase "SURGICAL PRODUCTS GROUP" in smaller, black letters. The logo is simple and professional.

K091120

MAR 1 9 2010

510(k) SUMMARY

Date of Summary: March 11, 2010

Manufacturer and Submitter:

Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265

Tel: (678) 479-1610 Fax: (678) 479-4495

Contact: Mrs. Jerri Mann E-mail: jerri.mann@porex.com

Trade Name: MEDPOR® CONTAIN™ Implant

Class: II, 21 CFR 872.3930 Bone grafting material

Product Code: NPK

Substantially equivalent to:

MEDPOR® Surgical Implant Material; Preformed Cranial & Facial Implants, K922489 2) GORE RESOLUT® ADAPT Regenerative Membrane, K051267 3) Osteo-Mesh TM-300 (Titanium Ridge Augmentation Mesh), K984230 4) Cytoplast™ Regentex Titanium 250, K972278 5) IMTEC/Titanium Mesh, K970841

Device Description:

Indications for Use:

The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible, and zygoma.

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Technological Characteristics:

The MEDPOR CONTAIN Implant can be used to contain, support and maintain the space for bone graft material that is used in the maxilla, mandible or zygoma to reestablish missing bone or establish new bone for support of dental implants. The MEDPOR CONTAIN Implant can be trimmed or cut to size and bent to conform to the needs of the individual patient. It may be stabilized with tacks, sutures, wires, or craniofacial screws. The MEDPOR CONTAIN Implant is manufactured from the same material, packaged, labeled and sterilized the same as all other MEDPOR Surgical Implant Material: Preformed Cranial and Facial Implants.

Substantial Equivalence:

The MEDPOR CONTAIN Implant shares indications and design principles with the following predicate devices:

Device Name	ProposedDevice	PredicateDevice #1	PredicateDevice #2	PredicateDevice #3	PredicateDevice #4	PredicateDevice #5
	MEDPORCONTAINImplant	MEDPORSurgical ImplantMaterial;PreformedCranial & FacialImplants	GORERESOLUTADAPTRegenerativeMembrane	Osteo-Mesh TM-300 (TitaniumRidgeAugmentationMesh)	IMTEC/TitaniumMesh	CytoplastRegnetexTitanium 250(Titanium RidgeAugmentationMesh
510(k)Number	ThisSubmission	K922489	K051267	K984230	K970841	K972278
Intended Use	The MEDPORCONTAINImplant isintended tostabilize, supportand providespacemaintenance forbone graftmaterials in themaxilla,mandible, andzygoma.	For augmentationor restoration ofbony contour incraniofacialdefects.	For use duringthe process ofguided boneregeneration as abioabsorbablemembrane forsupporting:augmentationaroundimmediatelyplacedendosseousimplants orexistingendosseousimplants (e.g.,dehiscence andfenestrationdefects,extractionsockets); ridgeaugmentation forlater implantationof endosseousimplants; andsinus procedures(e.g., sinuswindow, sinuslift).	For stabilizationand support ofbone grafts indento-alveolarbony defect sites.	For the repair ofboth localizedand extensivealveolar ridgedefects,protection for thegraft site,membranesupport, tissuesupport.	A temporarilyimplantablematerial (non-resorbable) foruse as a space-making barrier inthe treatment ofperiodontaldefects.
Material	A linear, high-densitypolyethylenebiomaterial	A linear, high-densitypolyethylenebiomaterial	Syntheticresorbablecopolymermaterials	Grade 1 Titanium	Expanded CPTitanium	A nonporous highdensitypolytetrafluoroethylene filmenforced with atitanium

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Design	15mm x 30mm,25mm x 30mm,45mm x 30mmsheets in 0.25mmand 0.35mmthicknesses andother shapes andsizes as well aspatient specificcustomizedshapes	Preformedshapes includingsheets, micro thinsheets and ultrathin sheets	Regenerativemembrane 15mmx 20mm, 20mm x25mm and 25mmx 30mm	Ti nitride coatedperforated mesh0.009 inch thick25mm x 30mm,and12mm x 25mm	34mm x 25mm0.10mmthickness	0.25 mm thick25mm x 30mm,12mm x 25mm,14mm x 20mm,14mm x 24mm,20mm x 25mm,13mm x 19mmand 13mm x18mm
Sterile/Non-Sterile	Sterile	Sterile	Sterile	Non-Sterile	Sterile	Sterile
SterilizationMethod	EtO	EtO	Gamma	Autoclave	Not specified	Steam
Biocompatible	Yes	Yes	Yes	Yes	Yes	Yes

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Ms. Jerri L. Mann Regulatory Compliance Manager Porex Surgical, Incorporated 15 Dart Road Newnan, Georgia 30265

MAR 1 9 2010

Re: K091120

Trade/Device Name: MEDPOR® CONTAIN™ Implant Regulation Number: 21CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: March 11, 2010 Received: March 12, 2010

Dear Ms. Mann:

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.

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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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

1- for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,

Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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09/120 Indications for Use

510(k) Number: K091120

Device Name: MEDPOR® CONTAIN™ Implant

Indications for Use: The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices

510(k) Number: K09112

Page 1 of 1

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.