Biopor® Porous Polyethylene Implants in sheet configurations are intended for the augmentation or reconstruction of the craniofacial skeleton, including the cranial skeleton, orbit, nasal bones and the zygoma.

Device Description

Biopor® Porous Polyethylene Implants are manufactured of porous high-density polyethylene (PPE), a biomaterial that is contoured or carved to suit the anatomical and functional requirements of the patient. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend (AOC). Biopor® Porous Polyethylene Implants are provided STERILE and must not be resterilized.

AI/ML Overview

The provided FDA 510(k) summary document for the Biopor Porous Polyethylene Implants does not describe a study involving an AI/Machine Learning device or a diagnostic device where the acceptance criteria would be related to performance metrics like sensitivity, specificity, or reader improvement.

Instead, this document is for a physical medical implant (Preformed Alterable Cranioplasty Plate). The "performance testing" described in the document refers to biocompatibility and physical/mechanical properties of the implant, not diagnostic accuracy or AI algorithm performance.

Therefore, I cannot provide the information requested in your prompt because it pertains to the performance evaluation of an AI/ML or diagnostic device, which is not what this document describes.

However, I can extract the "acceptance criteria" and "reported device performance" as they relate to the physical and biological characteristics of the implant described in this document.

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

The "acceptance criteria" for this device are related to its material properties, biocompatibility, and physical performance as an implant. The "study" refers to a series of tests conducted to ensure safety and function.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Biocompatibility Tests
Cytotoxicity Study Using the End-Point Titration	No cytotoxicity detected	The extract tested negative after 24, 48 and 72 hours. No cytotoxicity detected.
Murine Local Lymph Node Assay (LLNA)	Not considered sensitizing	Under the conditions of the study, the material was not considered sensitizing to the mouse.
ISO Modified Intracutaneous Solution	Negligible irritation	The primary irritation index characterization for the test article was negligible.
USP and ISO Modified Systemic Toxicity	No evidence of systemic toxicity	There was no evidence of systemic toxicity.
ISO Muscle Implantation	Classified as a non-irritant	After 2 weeks, the test article was classified as a non-irritant.
Genotoxicity: Mouse Bone Marrow Micronucleus	No evidence of cellular toxicity	The coating showed no evidence of cellular toxicity.
Genotoxicity: Bacterial Reverse Mutation	No evidence of cellular toxicity	The coating showed no evidence of cellular toxicity.
Genotoxicity: In Vitro Chromosomal Aberration	No evidence of cellular toxicity	The coating showed no evidence of cellular toxicity.
Bone Implantation Study in the Femur of the Rabbit	Normal healing and absorption of test article (where applicable)	The test article was absorbed and all sites were healing normally.
AOC Polymer Hemolysis	Non-hemolytic	The test article was non-hemolytic.
PPE Post-irradiation Cytotoxicity	Non-cytotoxic	The test articles were non-cytotoxic.
ISO Intramuscular Implantation AOC Coated & Uncoated PPE	Fibrovascular ingrowth indicates tissue integration/compatibility.	Fibrovascular ingrowth occurred into coated and uncoated implants.
Physical/Mechanical Tests
Suture Pull-out of AOC-Coated Biopor Porous Polyethylene Implant	Meet acceptance criteria (specific numerical criteria not detailed in this summary, but implied by "met")	The test articles met acceptance criteria.
Biopor Sheet Performance Qualification	Meet acceptance criteria for flexibility (specific criteria not detailed)	The test articles met acceptance criteria.
Porosity Characterization of Porous Polyethylene Implants	Pore size greater than 40 µm	The test articles met acceptance criteria (implying pore size was > 40 µm).
Endotoxin Specification	< 2.15 EU/device	(No specific measured value given in the results table, but the statement says "The endotoxin specification of the device is < 2.15 EU/device." and implies it was met.)

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

Sample Sizes:
- Cytotoxicity: Not specified (in vitro study).
- Murine Local Lymph Node Assay (LLNA): Mouse model, sample size not specified.
- ISO Modified Intracutaneous Solution: 3 rabbits.
- USP and ISO Modified Systemic Toxicity: 10 mice.
- ISO Muscle Implantation: Not specified (rabbits).
- Genotoxicity (Micronucleus, Bacterial Reverse Mutation, Chromosomal Aberration): Not specified (in vitro studies).
- Bone Implantation Study: Not specified (rabbits).
- AOC Polymer Hemolysis: Not specified (in vitro study).
- PPE Post-irradiation Cytotoxicity: Not specified (in vitro study).
- ISO Intramuscular Implantation AOC Coated & Uncoated PPE: Not specified (rabbits).
- Suture Pull-out: Not specified (number of coated implants tested).
- Flexibility (Sheet Performance): Not specified (number of coated/uncoated implants tested).
- Porosity Characterization: Not specified (number of coated/uncoated implants tested).
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given this is an FDA submission for a medical device, the studies would typically be conducted under Good Laboratory Practice (GLP) standards. The biocompatibility profile was "leveraged from testing to support K043133 (a predicate ancestor of K141880)," indicating a reliance on previously gathered data for similar materials.

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

This question is not applicable to this type of device submission. There is no "ground truth" established by experts in the context of diagnostic accuracy for an AI/ML device. The "ground truth" for these tests is based on objective measurements (e.g., cell viability, physical strength, pore size) and established biological responses in animal models, assessed by qualified laboratory personnel and researchers, not expert readers.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus ground truth in diagnostic imaging studies, not for physical/chemical testing of an implant.

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

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this device or its testing.

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

No, this pertains to AI algorithm performance which is not applicable here.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

Bioreactivity Data: In vitro cell culture responses, observed reactions in animal models (e.g., irritation, sensitization, toxicity, tissue integration).
Physical Property Measurements: Direct measurements of material properties like pore size and strength.
Sterility and Endotoxin Levels: Controlled laboratory measurements.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set for this device.

Summary

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

September 27, 2016

Ceremed, Inc. Ms. Chelsea Mitchell Vice President of Regulatory Affairs 3643 Lenawee Avenue Los Angeles, California 90016

Re: K161446

Trade/Device Name: Biopor Porous Polyethylene Implants Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO Dated: August 2, 2016 Received: August 26, 2016

Dear Ms. Mitchell:

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 devicerelated 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.

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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" (21 CFR 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,

Carlos L. Pena SS

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161446

Device Name Biopor Porous Polyethylene Implants

Indications for Use (Describe)

Biopor Porous Polyethylene Implants in sheet configurations are intended for the augmentation or reconstruction of the craniofacial skeleton, including the cranial skeleton, orbit, nasal bones and the zygoma.

Type of Use (Select one or both, as applicable)

Research and/or Educational Use Only
Commercial Use

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (K) SUMMARY:

Submitted by:

Chelsea Mitchell Ceremed. Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: (424) 258-1888 Fax: (310) 815-2130

Contact Person:	Chelsea Mitchell
Date Prepared	September 27, 2016
Common/Usual Name:	Porous High Density Polyethylene(HDPE) Surgical Implant
Proprietary Name:	Biopor® Porous Polyethylene Implants
Classification Name:	Plate, Cranioplasty, Preformed, Alterable(21 CFR 882.5320)
Product Code:	GWO

Predicate Device:

1. Ceremed, Inc. Biopor® Porous Polyethylene Surgical Implants (K141880)

Description of the device:

Intended use (Indications For Use):

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Comparison of Technology to Predicate Device:

The differences and similarities in technological characteristics and intended use between the subject and predicate devices are listed below:

	Biopor® PPE	Biopor® PPE
510k Number	K161446	K141880
Indications forUse Statement	Biopor® PorousPolyethylene Implantsin sheet configurationsare intended for theaugmentation orreconstruction of thecraniofacial skeleton,including the cranialskeleton, orbit, nasalbones and the zygoma.	Biopor® Porous Polyethylene Implants in block,sheet, and anatomical shapes are intended for theaugmentation or reconstruction of the"maxillofacial skeleton".
Materials	PPE with AOC option	PPE with Titanium and AOC options
Configuration	Sheets	Sheets and anatomical shapes
Sterility	Unchanged	Sterile via electron beam irradiation
Packaging	Unchanged	Inner packet, outer Tyvek pouch

Biocompatibility and Performance Testing:

Performance testing of the Biopor® Porous Polyethylene Implants was completed. The biocompatibility profile was leveraged from testing to support K043133 (a predicate ancestor of K141880). The endotoxin specification of the device is < 2.15 EU/device. These data are applicable to Preformed Cranioplasty Plate (21 CFR 882.5320) and support the substantial equivalence of the subject device to the predicate (K141880). The test data is summarized below:

Test	Test Method Summary	Results
CytotoxicityStudy Using theEnd-PointTitration	An in vitro study of the AOCcoating used dilutions of anextract on a confluent monolayerof mouse fibroblast cells.	The extract tested negative after 24, 48and 72 hours. No cytotoxicity detected.
Murine LocalLymph NodeAssay (LLNA)	A study of the AOC coating fordelayed contract sensitizationusing the LLNA mouse model	Under the conditions of the study, thematerial was not considered sensitizing tothe mouse.
ISO ModifiedIntracutaneousSolution	A study of the AOC coating forirritation and sensitization.3 rabbits were injected into theskin and observed for 72 hrs.	The primary irritation indexcharacterization for the test article wasnegligible.
USP and ISOModifiedSystemicToxicity	A study of the AOC coating forsystemic toxicity. 10 mice wereadministered a dose of 50 ml/kgand observed for 7 days.	There was no evidence of systemictoxicity.
ISO MuscleImplantation	The AOC coating for evaluatedfor toxicity. Test articles wereimplanted into the muscle ofrabbits.	After 2 weeks, the test article wasclassified as a non-irritant.
GenotoxicityMouse BoneMarrowMicronucleus	The AOC coating for evaluatedfor genotoxicity using the mousebone marrow micronucleusmodel.	The coating showed no evidence ofcellular toxicity.
Genotoxicity:Bacterial ReverseMutation	The AOC coating for evaluatedfor genotoxicity using BacterialReverse Mutation.	The coating showed no evidence ofcellular toxicity.
Genotoxicity: InVitroChromosomalAberration	The AOC coating for evaluatedfor genotoxicity using In VitroChromosomal Aberration.	The coating showed no evidence ofcellular toxicity.
BoneImplantationStudy in theFemur of theRabbit	The AOC coating was implantedinto the femurs of rabbits andevaluated after 4 and 8 weeks.	The test article was absorbed and all siteswere healing normally.
AOC PolymerHemolysis	The AOC coating for evaluatedfor hemolysis using In Vitrorabbit red blood cells.	The test article was non-hemolytic.
PPE Post-irradiationCytotoxicity	An in vitro study of theirradiated PPE implant extractusing MEM Elution.	The test articles were non-cytotoxic.
ISOIntramuscularImplantationAOC Coated &Uncoated PPE	AOC Coated & Uncoated PPEdevices were implanted intorabbit muscle and histopathologywas performed after 1, 2 and 4weeks.	Fibrovascular ingrowth occurred intocoated and uncoated implants.
Suture Pull-out ofAOC-CoatedBiopor PorousPolyethyleneImplant	Coated implants were evaluatedfor strength using a suture pull-out test method	The test articles met acceptance criteria.
Biopor SheetPerformanceQualification	Coated and uncoated implantswere evaluated for flexibility.	The test articles met acceptance criteria.
PorosityCharacterizationof PorousPolyethyleneImplants	Coated and uncoated implantswere evaluated for porosity withthe criteria of pore size greaterthan 40 µm.	The test articles met acceptance criteria.

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Substantial Equivalence:

The Biopor® Porous Polyethylene Implants in this submission represent a line extension of additional sheet configurations intended for use in the craniofacial skeleton, and have a comparable intended use and indications for use as the predicate Biopor® Porous Polyethylene Implants indicated for use in the maxillofacial skeleton (K141880). This submission contains implants for use in the craniofacial skeleton. They are similar to one type of implants currently marketed by Ceremed.

The biocompatibility profile of the subject devices is leveraged from that of the predicate device. The mechanical properties of subject Biopor® Porous Polyethylene Implants meet the same acceptance criteria as the predicate device sheet configurations.

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).