MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Device Description

The MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.

The proposed MatrixNEURO Preformed Meshes are precontoured to cover common cranial defects manufactured from grade 2 titanium that are designed for use with MatrixNEURO Cranial Plating System screws. The Preformed Meshes are offered sterile packed and are intended for single use only.

AI/ML Overview

The provided document K140462 describes a Special 510(k) Summary for the MatrixNEURO Preformed Mesh. This submission focuses on medical devices, specifically preformed alterable cranioplasty plates, and therefore the acceptance criteria and study information requested are not applicable in the context of AI/ML-based medical devices or diagnostic software.

The document details the following about the device:

Device Name: MatrixNEURO Preformed Mesh (part of the MatrixNEURO Cranial Plating System)
Intended Use: Fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.
Device Description: Precontoured meshes manufactured from grade 2 titanium, designed for use with MatrixNEURO Cranial Plating System screws. They are sterile-packed and intended for single use.
Comparison to Predicate Device: The proposed preformed meshes have identical indications for use and numerous technological similarities (material, thickness, mesh pattern, screw compatibility, etc.) to the predicate device, the Synthes MatrixNEURO Cranial Plating System (K123723). The primary difference is that the proposed devices are precontoured, while the predicate is provided flat.
Non-clinical performance data: Non-clinical testing was conducted, including "Load at 2 mm of displacement," "Max Load between 0 and 2 mm displacement," and "Stiffness at 2 mm of displacement." These tests concluded that the mechanical performance of the proposed device is comparable to the predicate.
Clinical performance data: The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

Therefore, regarding your specific questions for acceptance criteria and study details, based on the provided text, the following applies:

A table of acceptance criteria and the reported device performance: Not applicable. The submission refers to non-clinical performance data (load, max load, stiffness) and states it's comparable to the predicate but does not provide specific numerical acceptance criteria or detailed performance tables in the provided summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. "Clinical testing was not necessary." The non-clinical performance data would relate to material testing, not human test sets.
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): Not applicable, as there was no clinical testing requiring ground truth establishment by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there was no clinical testing.
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 physical medical device (mesh), not an AI/ML-based diagnostic or assistive technology for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was established. For the non-clinical tests, the "ground truth" would be the measured physical properties compared against established engineering standards or the predicate device's properties.
The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional medical device (implantable mesh) and not for an AI/ML-driven device. Thus, many of the requested details regarding clinical studies, ground truth, and AI performance metrics are not relevant to this submission. The "study" described is a non-clinical mechanical comparison to a predicate device to establish substantial equivalence.

Summary

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K140462

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Special510(k) Summary

Page 1 of 2

Date Prepared	February 20, 2014	JUN 1 3 2014
Submitter	Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380United States of America
Contact	Alan T. Haleyhaley.alan@synthes.com484.356.9763 (voice)484.356.9682 (fax)
Device Name	MatrixNEURO Preformed Mesh(part of the MatrixNEURO Cranial Plating System)

Device Classification Information

ProductCode	Device Name	DeviceClass	RegulationNumber	Regulation Description
GWO	Plate, Cranioplasty,Preformed, Alterable	2	882.5320	Preformed alterablecranioplasty plate

Predicate Devices

Synthes MatrixNEURO Cranial Plating System (K123723)

Indications for Use

MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Device Description

The MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.

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Image /page/1/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. To the right of the word is a small circle with an R inside, indicating a registered trademark. The word and logo are placed on a white background.

5 510(k) Summary (continued)

Comparison to Predicate Devices

Indications

The indications for proposed preformed meshes are identical to the predicate device.

Technological similarities between the predicate MatrixNEURO Reconstruction Mesh and the proposed MatrixNEURO Preformed Mesh:

Same principles of operation metallic implants for the fixation of bone. .
. Same thickness as the predicate.
. Same mesh pattern (hourglass) as the predicate.
Same bar width as the predicate.
Same screw recess type (single-sided) as the predicate .
Same screw recess inner and outer diameter as the predicate and therefore compatible with . same screws.
. Same strength-based color coding gradient as the predicate.
. Same material as the predicate.
Both the proposed device and the predicate are provided sterile-packed. .

Technological differences between the predicate MatrixNEURO Reconstruction Mesh and the proposed MatrixNEURO Preformed Mesh:

The proposed devices are precontoured to cover common cranial defects and may be further . contoured by the surgeon as necessary to fit the needs of each patient. The predicate device is
provided flat and may be contoured by the surgeon as necessary to fit the needs of each of ﺘ patient.

Non-clinical performance data

Non-clinical testing and analyses comparing the proposed devices to the predicate include:

Load at 2 mm of displacement .
. Max Load.between 0 and 2 mm displacement
. Stiffness at 2 mm of displacement

The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO Preformed Mesh is comparable to that of the predicate.

Clinical performance data

Clinical testing was not necessary for the determination of substantial equivalence.

Substantial Equivalence

The proposed devices have the same intended use as the predicate devices. The non-clinical performance data discussed in this submission demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the predicate devices. It is concluded that the information included in this submission supports substantial equivalence.

(end of summary)

Synthes MatrixNEURO Cranial Plating System

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

June 13, 2014

Synthes (USA) Products, LLC Mr. Alan Haley Senior Regulatory Affairs Specialist 1301 Goshen Pkwy. West Chester, PA 19380

K140462 Re:

Trade/Device Name: MatrixNEURO Preformed Mesh Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO Dated: May 5, 2014 Received: May 16, 2014

Dear Mr. Haley:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Mr. Alan Haley

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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,

່າ:

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) K140462

Device Name

MatrixNEURO Preformed Mesh (part of the MatrixNEURO Cranial Plating System)

Indications for Use (Describe)

MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

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

[X] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -S

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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).