The MEDPOR Fixation System - Cranial is a plate and screw system to be used in Cranial Surgery. The components that comprise the system are composed of titanium plates. titanium alloy bone screws, titanium alloy implant screws, and surgical stainless steel instruments for the installation of the plates and screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 Standard. The bone and implant screws are manufactured of 6-4 ELI titanium that meets the ASTM F136 standard. The implant screws are designed to be used with MEDPOR polyethylene implants manufactured by Porex Surgical under K832283. K922489. K952677, K040364 and K083621. The screws and plates have been color anodized for ease of use by a surgeon. The blue anodized side of the plate corresponds to the blue anodized bone screw and the magenta anodized side of the plate corresponds to the magenta anodized implant screw. The MEDPOR Fixation System -- Cranial is sterilized by ethylene oxide sterilization. The instruments and unused components can be resterilized via steam sterilization.

AI/ML Overview

This document is a 510(k) premarket notification for the MEDPOR® Fixation System - Cranial. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study to prove device performance against those criteria. In the context of a 510(k) submission for a device like plates and screws, the "acceptance criteria" are generally related to demonstrating that the new device is as safe and effective as existing legally marketed devices (predicate devices) and that any differences do not raise new questions of safety or effectiveness.

Therefore, the requested information elements (1-9) which typically relate to performance studies for novel or significantly modified devices, are not explicitly provided in this 510(k) summary. A 510(k) does not usually include a formal "study" with stated acceptance criteria and device performance results in the same way a PMA or de novo submission might. Instead, it relies on comparisons to predicate devices and adherence to established material standards and manufacturing practices.

Here's a breakdown of what can be extracted and what is not applicable or stated:

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

Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific performance study in this 510(k) summary. The acceptance criteria for a 510(k) is generally the demonstration of "substantial equivalence" to predicate devices, meaning the new device has "similar technological characteristics" and "same intended use."
Reported Device Performance: No specific performance metrics (e.g., tensile strength, fatigue life, etc.) are reported with numerical values in this summary. The submission implies that the material and design choices (titanium, specific alloys) meet established standards (ASTM F67, ASTM F136), which are themselves forms of performance criteria.

2. Sample size used for the test set and the data provenance

Not applicable as no specific device performance testing study with a "test set" and "data provenance" is detailed in this 510(k) summary. The comparison is primarily against the characteristics of predicate devices.

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

Not applicable as there is no "test set" ground truth established by experts in the context of this 510(k) summary. Substantial equivalence is assessed by regulatory reviewers based on design, materials, and intended use.

4. Adjudication method for the test set

Not applicable for the same reasons as #3.

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. This is a medical device for surgical fixation, not an AI or imaging diagnostic device.

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

Not applicable. This is a medical device for surgical fixation, not an algorithm.

7. The type of ground truth used

The "ground truth" for a 510(k) submission for this type of device is the evidence that the device's technological characteristics (materials, design, sterilization) and intended use are substantially equivalent to legally marketed predicate devices, which are themselves considered safe and effective. The reference to conformity with ASTM standards (F67 and F136) serves as a form of "ground truth" for material properties.

8. The sample size for the training set

Not applicable as there is no "training set" in the context of this 510(k) submission. Design and manufacturing are based on established engineering principles and material standards.

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

Not applicable for the same reasons as #8.

Summary based on the provided document:

The provided document is a 510(k) Summary. For devices like the MEDPOR® Fixation System - Cranial, the "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence to predicate devices already on the market. The "study" proving this largely involves a comparison of technological characteristics (materials, design, indications for use, sterilization) and adherence to recognized standards.

Table of Acceptance Criteria (Implied by Substantial Equivalence) and Reported Features:

Criteria Category (Implied)	Acceptance Criteria (How substantial equivalence is demonstrated)	Reported Device Features / Performance
Intended Use	Must be substantially equivalent to predicate devices.	"Intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton." (Compared to predicate intended uses which include cranial, craniofacial, and reconstructive procedures of the craniofacial skeleton).
Device Classification	Must align with predicate devices or existing classifications.	Class II, Code HBW, Reg. No. 882.5360 - Cranioplasty plate fastener (Matches or is consistent with classifications of predicate devices).
Materials	Must be substantially equivalent to predicate devices, preferably with a history of safe use, and adhere to recognized standards.	Plates: CP Grade 4 Titanium (Adheres to ASTM F67 Standard). Screws: 6-4 ELI Titanium Alloy (Meets ASTM F136 standard). (Comparable to titanium/titanium alloy used in multiple predicate devices, though one predicate uses bioabsorbable material).
Design	Must be substantially equivalent in form and function (e.g., plates and screws for fixation).	Plate and screw system. (Exhibited by all predicate devices). Includes color anodization for ease of use.
Sterilization	Must use appropriate and validated sterilization methods.	Ethylene Oxide & Steam sterilization. (Comparable to predicate devices which use steam, or are supplied sterile/non-sterile with instructions for steam sterilization).
Instrumentation	Presence of dedicated instrumentation.	Yes. (Comparable to most predicate devices).

Explanation of Study (Substantial Equivalence Demonstration):

The "study" in this context is the detailed comparison provided in the "Substantial Equivalence" section and the comparative table on page 2 of the document. This comparison directly addresses how the MEDPOR Fixation System - Cranial aligns with the identified predicate devices:

Comparison of Intended Use: The document argues that the intended use of the MEDPOR system (fixating cranial implants to the cranial skeleton) is comparable to the broad craniofacial, cranial, and reconstructive procedures of the predicate devices.
Comparison of Materials: The use of specific titanium grades (CP 4 Titanium for plates, 6-4 ELI Titanium Alloy for screws) is stated to meet ASTM standards F67 and F136, respectively. The document highlights that titanium has a "long history of use in surgical implantable products" and that these materials are consistent with most predicate devices (Predicate Device #1 is an exception, being bioabsorbable).
Comparison of Technological Characteristics: The document states that the "technological characteristics of the design are substantially equivalent to the predicate devices and any slight differences do not raise new issues of safety and effectiveness." This includes design as a plate and screw system, dedicated instrumentation, and sterilization methods.

Missing/Not Applicable Information:

Sample Size for Test Set/Training Set: Not applicable for a 510(k) based on substantial equivalence comparison of device characteristics.
Data Provenance: Not applicable.
Experts/Ground Truth for Test/Training set: Not applicable in the sense of clinical study experts. The "ground truth" hinges on the established safety and effectiveness of the predicate devices and conformity to recognized standards.
Adjudication Method: Not applicable.
MRMC or Standalone AI Study: Not applicable as this is not an AI/diagnostic device.

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 text "SURGICAL PRODUCTS GROUP" in a smaller font size.

510(k) SUMMARY

DEC - 3 2010

KI 01 835

Date of Summary: September 17, 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® Fixation System - Cranial

Common Name: Plates and Screws

Class: II, 21 CFR 882.5360 - Cranioplasty plate fastener

Product Code: HBW

Substantially equivalent to:

1. Takiron Co., Ltd OSTEOTRANS™-MX Bioabsorbable Bone Fixation System K073006
1. Synthes (USA) Synthes Low Profile Neuro System K022012
1. Synthes (USA) Synthes (USA) Craniofacial Plates K021642
1. Synthes (USA) SMF Titanium (TI) Alloy Bone Screws K963546
1. Stryker Leibinger Stryker Leibinger Universal Neuro System K031659

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Device Description:

Indications for Use:

The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.

Technological Characteristics:

Documentation is provided which demonstrates that the MEDPOR Fixation System -Cranial is substantially equivalent to other legally marketed devices. The technological characteristics of the design are substantially equivalent to the predicate devices and any slight differences do not raise new issues of safety and effectiveness.

Substantial Equivalence:

The following matrix is a comparison of the MEDPOR Fixation System - Cranial to the predicate devices. The MEDPOR Fixation System - Cranial is substantially equivalent in design and intended use to each of the predicate devices. The MEDPOR Fixation System - Cranial is substantially equivalent in material to the predicate devices that are manufactured from titanium. Titanium has a long history of use in surgical implantable products.

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Device	Proposed Device	Predicate Device #1	Predicate Device #2	Predicate Device #3	Predicate Device #4	Predicate Device #5
	MEDPORFixation System- Cranial	OSTEOTRANS-MX BioabsorbableBone FixationSystem	Synthes LowProfile NeuroSystem	SynthesCraniofacialPlates	SMF Titanium(TI) Alloy BoneScrews	StrykerLeibengerUniversal NeuroSystem
510(k) Number	This Submission	K073006	K022012	K021642	K963546	K031659
DeviceClassification	Class II,Code HBW,Reg. No.882.5360	Class II,Code GWO, HBWReg. No.882.5320,882.5360	Class II,Code JEY, GXR,DZLReg. No.872.4760,882.5250,872.4880	Class II,Code JEYReg. No.872.4760	Class II,Code DZLReg. No.872.4880	Class II,Code JEYReg. No.872.4760
Intended Use	The MEDPORFixation System- Cranial isintended for usein cranial surgeryto fixateMEDPORcranial implantsto thesurroundingcranial skeleton.	TheOSTEOTRANS -MX BioabsorbableBone FixationSystem is intendedfor use in traumaand reconstructiveprocedures of thecraniofacialskeleton, includingfracture of thecranium, infantcraniofacialsurgery (i.e.craniosynotosis,congenitalmalformations),pediatricreconstructiveprocedures,reconstructiveprocedures of thecranium,craniotomy flapfixation.	The Synthes LowProfile NeuroSystem isintended for usein selectivetrauma of themidface andcraniofacialskeleton;craniofacialsurgery;reconstructiveprocedures; andselectiveorthognathicsurgery of themaxilla and chin.	The SynthesCraniofacialPlates areintended for usein selectivetrauma of themidface andcraniofacialskeleton;craniofacialsurgery;reconstructiveprocedures; andselectiveorthognathicsurgery of themaxilla andchin.	The SMF TiAlloy BoneScrews areintended forcraniofacial andmandibulartrauma andreconstruction.	The StrykerLeibingerUniversal NeuroSystem is a low-profile plate andscrew systemintended forosteotomy,craniotomy,stabilization andrigid fixation ofcraniofacialfractures andreconstruction ofnon-load bearingareas.
Materials	Plates - CP 4TitaniumScrews - 6/4 ELITitanium Alloy	Bone Plates,Meshes andScrewsmanufacturedfrom compositesof Hydroxyapatiteand Poly-L-Lactide(HA/PLLA)	Plates -TitaniumScrews - Ti-6Al-7Nb TitaniumAlloy	Titanium	Titanium Alloy	CP Titanium orTi6Al4V Alloy
DedicatedInstrumentation	Yes	Not Stated	Yes	Yes	Yes	Yes
Sterile/Nonsterile	Supplied Sterile	Sterile	Nonsterile orSterile-packed	Nonsterile orSterile-packed	Nonsterile orSterile-packed	Nonsterile
SterilizationMethods	Ethylene Oxide& Steam	Not Stated	Steam	Steam	Steam	Steam

ﻪ

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

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

Porex Surgical, Inc. C/O Stephanie Fullard Regulatory Affairs Manager 15 Dart Road Newnan, GA 30265

Re: K101835

Trade/Device Name: MEDPOR Fixation System - Cranial Regulation Number: 21 CFR 882.5360 Regulation Name: Cranioplasty plate fastener Regulatory Class: Class II Product Code: HBW Dated: November 22, 2010 Received: November 23, 2010

DEC -- 3 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 iudicions 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, Or ve 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Keoin Alexander

Image /page/4/Picture/7 description: The image shows the handwritten word "for" in cursive. The letter "f" has a long, descending loop that extends below the baseline, and the "o" and "r" are connected with a smooth, flowing line. The writing appears to be done with a pen or marker, and the ink is black. The background is plain white.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological, and Ear.

Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

DEC - 3 2010

510(k) Number (if known): K101835

Device Name: MEDPOR® Fixation System - Cranial

Indications for Use: The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K101835

Regulation Number and Section

§ 882.5360 Cranioplasty plate fastener.

(a)
Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.(b)
Classification. Class II (performance standards).