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

Device Description

The purpose of this Special 510(k) is to add the CAN configuration to MEDPOR CONTAIN Implants. The MEDPOR CONTAIN CAN Implant is a cylinder shaped, thin walled, highly porous, implant that is closed on one end and open on the other. It is made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as MEDPOR CONTAIN Implants in sheet form. Like the sheet configuration, the CAN is non-resorbable, allows for host integration and is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing. The CAN configuration will minimize the need for the surgeon to shape the MEDPOR CONTAIN Sheet Implant, which will reduce the time required for performing the procedure and reduce the possibility of introducing contaminants or debris to the surgical site.

AI/ML Overview

The provided text is a 510(k) Summary for the MEDPOR® CONTAIN™ CAN Implant. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

This document describes a medical device clearance process based on substantial equivalence, not a study designed to prove the device meets specific acceptance criteria through measured performance.

Therefore, most of the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text. The text focuses on comparing the new device's characteristics to a predicate device to establish substantial equivalence, rather than detailing performance studies with specific metrics.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be answered from the provided text. The document does not describe specific acceptance criteria (e.g., a target accuracy or sensitivity) for the "MEDPOR® CONTAIN™ CAN Implant" nor does it report performance data against such criteria. The submission is for substantial equivalence to a predicate device. The "Safety & Effectiveness" row in the Substantial Equivalence Matrix states "No changes in function and intended use," implying that its safety and effectiveness are considered equivalent to the predicate without needing new performance metrics to be proven.

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

Cannot be answered from the provided text. There is no mention of a "test set," "sample size," or data provenance, as a performance study of the device against specific metrics was not presented in this 510(k) summary.

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)

Cannot be answered from the provided text. There is no mention of experts or ground truth establishment for a test set.

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

Cannot be answered from the provided text. There is no mention of adjudication or a test set.

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

Cannot be answered from the provided text. This device is an implantable medical device, not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies.

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

Cannot be answered from the provided text. This device is an implant, not an algorithm.

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

Cannot be answered from the provided text. There is no mention of a "ground truth" as it pertains to a performance study for this device. The "ground truth" in this context would likely refer to the established safety and efficacy of the predicate device.

8. The sample size for the training set

Cannot be answered from the provided text. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" for such a device would refer to its manufacturing and design process.

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

Cannot be answered from the provided text. As above, there is no mention of a "training set" or "ground truth" in the context of typical AI/ML studies.

Summary of what can be extracted from the text, relevant to the inquiry's spirit of evaluating the device:

The "study" presented here is a substantial equivalence comparison to a predicate device, as required for a 510(k) submission.

Predicate Device: MEDPOR CONTAIN Implant (K091120)

Basis of Equivalence: The MEDPOR CONTAIN CAN Implant is deemed substantially equivalent based on:

Intended Use: Identical - to stabilize, support, and provide space maintenance for bone graft materials in the maxilla, mandible, and zygoma.
Material: Identical - Linear high-density polyethylene biomaterial.
Function and Design Principles: Substantially equivalent. The new "CAN" configuration (cylinder) is designed to minimize the need for the surgeon to shape the implant, compared to the predicate's "Sheet" configuration.
Manufacturing and Sterilization: Manufactured, packaged, labeled, and sterilized the same as other MEDPOR CONTAIN Implants.

Key Differences and Why They Don't Jeopardize Equivalence (as implied by clearance):

Shape: New device is Cylinder (Can), predicate is Flat (Sheet).
Diameter: New device has specified diameters (8, 9, 10 mm), predicate is not applicable for this dimension.
Thickness: New device is 0.40 mm, predicate devices were 0.25, 0.35, 0.45 mm. The new thickness is within the range of the predicate, and the change is considered minor in this context.

Conclusion from the document: The FDA determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This determination is based on the information provided regarding the device's characteristics and comparison to the predicate, not on new performance data demonstrating specific acceptance criteria.

Summary

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KI02184

Image /page/0/Picture/1 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.

510(k) Summary

JAN - 7 2011

Date of Summary: July 30, 2010

Manufacturer and Submitter:

Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265 Tel: (678) 479-1610 Fax: (678) 479-4495

Contact: Stephanie Fullard E-mail: stephanie.fullard(@)porex.com

Trade Name: MEDPOR® CONTAIN™ CAN Implant

Descriptive Name: MEDPOR CONTAIN Implant

Classification: II, 21 CFR 872.3930 - Bone grafting material

Product Code: NPK

Predicate Device: MEDPOR CONTAIN Implant (K091120)

Device Description:

Like the sheet configuration, the CAN is non-resorbable, allows for host integration and is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.

The CAN configuration will minimize the need for the surgeon to shape the MEDPOR CONTAIN Sheet Implant, which will reduce the time required for performing the procedure and reduce the possibility of introducing contaminants or debris to the surgical site.

ર - I

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Image /page/1/Picture/1 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.

Indications for Use:

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

Technological Characteristics: The MEDPOR CONTAIN CAN 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 re-establish missing bone or establish new bone for support of dental implants. The MEDPOR CONTAIN CAN Implant is designed to minimize the surgeon's need to shape, trim or cut the implant to fit a patient's specific needs. It may be stabilized with tacks, sutures, wires, craniofacial screws or dental implant retention screws. The MEDPOR CONTAIN CAN Implant is manufactured from the same material, packaged, labeled and sterilized the same as all other MEDPOR CONTAIN Implants.

Substantial Equivalence: The MEDPOR CONTAIN CAN Implant is substantially equivalent in intended use, material, function and design principles to the MEDPOR CONTAIN Implant.

	MEDPOR CONTAIN CAN	Predicate DeviceMEDPOR CONTAIN Implant
	Implant
510(k) Number	This Submission	K091120
Device Classification	Class II, Code NPK	Class II, Code NPK
	Reg. No. 872.3930	Reg. No. 872.3930
Intended Use	The MEDPOR CONTAIN CAN	The MEDPOR CONTAIN
	Implant is intended to stabilize,	Implant is intended to stabilize,
	support and provide space	support and provide space
	maintenance for bone graft	maintenance for bone graft
	materials in the maxilla,	materials in the maxilla,
	mandible and zygoma.	mandible and zygoma.
Material	Linear high-density	Linear high-density
	polyethylene biomaterial	polyethylene biomaterial
Shape	Cylinder (Can)	Flat (Sheet)
Diameter (mm)	8, 9, 10	Not Applicable
Thickness (mm)	0.40	0.25, 0.35, 0.45
Sterility	Sterile/Ethylene Oxide	Sterile/Ethylene Oxide
Single Use Only	Yes	Yes
Packaging	Double peel pouch	Double peel pouch
Shelf life	10 years	10 years
Safety & Effectiveness	No changes in function and intended use

Substantial Equivalence Matrix

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

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

Ms. Stephanie Fullard Regulatory Affairs Manager Porex Surgical, Incorporated 15 Dart Road Newnan, Georgia 30265

JAN - 7 2011

Re: K102184

Trade/Device Name: MEDPOR® CONTAIN™ CAN Implant Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: November 22, 2010 Received: November 24, 2010

Dear Ms. Fullard:

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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Page 2- Ms. Fullard

Enclosure

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/ ucml 15809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

h 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

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Indications for Use

510(k) Number: K102184

JAN - 7 2011

Device Name: MEDPOR® CONTAIN™ CAN Implant

Indications for Use: The MEDPOR CONTAIN CAN 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)

Susan Runoe

(Division Sign-Off) Division of Anesthesiology, General Hospltal Infection Control, Dental Devices

510(k) Number:

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.