The Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Device Description

The Synthes 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 reconstruction meshes are manufactured from titanium, are designed for use with Synthes MatrixNEURO Cranial Plating System screws, are offered sterile, and are intended for single use only. The screws are manufactured from titanium alloy, are designed for use with Synthes MatrixNEURO plates, burr hole covers, and meshes, may be offered sterile, and are intended for single use only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that demonstrates the Synthes MatrixNEURO Cranial Plating System meets them, based on the provided 510(k) summary:

This device notification (K123723) is a 510(k) submission for a medical device (device name: Synthes MatrixNEURO Cranial Plating System). The intent of a 510(k) is to demonstrate that the new device is "substantially equivalent" to one or more legally marketed predicate devices, meaning it is as safe and effective as a legally marketed device. For such submissions, clinical efficacy studies are not typically required if substantial equivalence can be demonstrated through non-clinical data.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly defined as specific numerical thresholds, but rather are based on demonstrating "comparability" to predicate devices in mechanical performance.

Acceptance Criteria (Demonstrates Comparability to Predicates)	Reported Device Performance
Cross-sectional area comparable to predicates	"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
Section modulus comparable to predicates	"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
Peak load at 2 mm of displacement comparable to predicates	"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
Stiffness at 2 mm of displacement comparable to predicates	"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
Insertion torque comparable to predicates	"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
Failure torque comparable to predicates	"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
Insertion factor of safety comparable to predicates	"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
Pullout load comparable to predicates	"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."

Study Information

Sample size used for the test set and the data provenance:
The document does not specify a "test set" in the context of clinical data for the proposed device, as no clinical studies were performed. The "test" in this context refers to non-clinical, mechanical performance testing. The sample sizes for these mechanical tests (e.g., number of meshes or screws tested for each parameter) are not provided in this summary.
Data provenance: Non-clinical performance data, likely from laboratory testing. Country of origin for this testing is not specified, but the submitter is Synthes (USA).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No "ground truth" was established by experts in the context of clinical data, as this was a non-clinical performance study. Mechanical performance metrics are typically measured by calibrated instruments and methods, not subjective expert assessment.
Adjudication method for the test set:
Not applicable. No expert adjudication was needed as the study involved non-clinical mechanical testing, not interpretation of clinical data.
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 device is a cranial plating system, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For non-clinical performance studies, the "ground truth" is typically the quantitative measurement obtained from standardized mechanical tests, as defined by relevant industry standards or internal validation protocols. No expert consensus, pathology, or outcomes data were used as "ground truth" for this non-clinical submission. The "ground truth" is the objective mechanical property being measured.
The sample size for the training set:
Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not involved here.
How the ground truth for the training set was established:
Not applicable, as no training set was used.

Summary

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K1237223

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510(k) Summary		Page 1 of 3
Date Prepared	September 3, 2013
Submitter	Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380United States of America
Contact	Alan T. Haleyhaley.alan@synthes.com(484) 356-9763
Device Name	Synthes MatrixNEURO Cranial Plating System
Device Class	2
Primary Product Code / Regulation Number

GWO / 21 CFR 882.5320

Secondary Product Codes / Regulation Numbers

GXR / 21 CFR 882.5250

Predicate Devices

. Synthes Neuro Plate and Screw System (K042365)
Synthes Low Profile Contourable Mesh Plates (K033160) .
Synthes Low Profile Neuro Plate and Screw System (K031807) .
. Synthes Low Profile Neuro Plate and Screw System (K022012)

Indications for Use

The Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Device Description

The Synthes 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 reconstruction meshes are manufactured from titanium, are designed for use with Synthes MatrixNEURO Cranial Plating System screws, are offered sterile, and are intended for single use only.

The screws are manufactured from titanium alloy, are designed for use with Synthes MatrixNEURO plates, burr hole covers, and meshes, may be offered sterile, and are intended for single use only.

SEP 05 2013

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510(k) Summary (continued)

Comparison to Predicate Devices

Indications

The predicate devices are indicated for use in a range of anatomic areas (midface, craniofacial skeleton, maxilla, chin) for a variety of surgical applications (craniofacial surgery, reconstructive procedures, selective orthognathic surgery). The Indications for Use statement of the Synthes MatrixNEURO Cranial Plating System falls within the scope of the broader Indications statements of the predicate devices. The differences in the Indications statement for the proposed device in comparison to the predicates do not constitute a new intended use.

Technological Similarities (Reconstruction Meshes)

Same principles of operation metallic implants for the fixation of bone. ●
Similar sizes and shapes compared to the predicates. .
Same thickness as the Low Profile Contourable Mesh Plate predicate. .
Same mesh pattern hourglass cut-outs to allow for similar intraoperative contourability. .
Same screw recess inner diameter as the predicate Synthes Neuro Plate and Screw System, . and therefore compatible with same screws.
Same strength-based color coding gradient as the predicate Synthes Neuro Plate and Screw . System mesh.
Same material as the predicates. .
The proposed reconstruction meshes are offered sterile. The meshes in the predicate Synthes . Neuro Plate and Screw System are offered sterile and non-sterile.

Technological Differences (Reconstruction Meshes)

The bar width and screw recess outer diameter dimensions of the proposed devices are . greater than those of the predicates.
The proposed Reconstruction Meshes feature a single-sided screw recess; the predicate . devices feature double-sided screw recesses.

Technological Similarities (Screws)

Same principles of operation metallic implants for the fixation of bone. .
. Similar lengths as the predicates.
Same solid shaft as the Low Profile Neuro System predicates. .
. Similar drive recess to the Low Profile Neuro System predicates.
Similar type of tips on standard screw as the predicates. .
Same type of tip on emergency screw as the predicates. .
Same thread pitch as the Synthes Neuro Plate and Screw System predicate. .
Same material as the predicates. .
The proposed screws are offered sterile. The screws in the predicate Synthes . Neuro Plate and Screw System are offered sterile and non-sterile.

Technological Differences (Screws)

The major diameter of the standard screw is slightly smaller than the Low Profile Neuro . System predicates.

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510(k) Summary (continued)

Page 3 of 3

Non-clinical performance data

Non-clinical performance data compared the proposed devices to the predicates:

. cross-sectional area
section modulus .
peak load at 2 mm of displacement .
. stiffness at 2 mm of displacement
. insertion torque
failure torque .
. insertion factor of safety
pullout load . •

The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates.

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 included 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)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird.

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

September 5, 2013

Synthes (USA) c/o Alan T. Haley Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380

Rc: K123723

Trade/Device Name: Synthes MatrixNEURO Cranial Plating System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, GXR Dated: August 5. 2013 Received: August 6, 2013

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 Mav 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. Isting 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 cither 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 is 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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Page 2 - Mr. Haley

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 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/ResourcesforYou/Industry/default.htm. 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/Jndustry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting 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: K123723

Device Name:

Synthes MatrixNEURO Cranial Plating System

Indications For Use:

The Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang -S

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K123723

Page 1 of 1

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).