The Universal Mesh is indicated for reconstruction, stabilization, and/or rigid fixation subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).

The Universal Mesh is indicated for non-load-bearing reconstruction in the maxillofacial skeleton of patients in whom skeletal growth is complete.

Device Description

The Universal Mesh - Sterile consists of an assortment of titanium meshes with different dimensions (small 60x60, medium 90x90, and large 120x120 mm) within the framework of the predicate Stryker Universal Mesh. The design of the meshes is not changed. The only addition is to provide the meshes sterile in a suitable packaging system. These meshes are sterilized by exposure to Ethylene Oxide. The intended use, the principles of operation, and the materials of construction have not changed.

AI/ML Overview

This document describes the Stryker Universal Mesh - Sterile, a device that has received 510(k) clearance from the FDA. The 510(k) submission primarily focuses on the change from a non-sterile to a sterile presentation of an already cleared device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical target values for each test. Instead, it lists the performance bench tests conducted and states that the device "met all pre-defined acceptance criteria and standards." The reported performance is a simple "Passed" for each test.

Characteristic	Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	EtO Residuals Test	Must pass ETO Residuals test	Passed
Biocompatibility	Cytotoxicity	Must pass Cytotoxicity test	Passed
Biocompatibility	Endotoxin Testing	Must pass Endotoxin test	Passed
Biocompatibility	Sterilization Validation	Must pass Sterilization Validation	Passed
Biocompatibility	Bioburden Verification	Must pass Bioburden Verification	Passed
Packaging Performance	Transportation Test	Must pass Transportation test	Passed
User Validation	System Handling Test	Must pass System Handling test	Passed

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample sizes used for the individual bench tests. It only states that these tests were performed.
The data provenance is from bench testing conducted by Stryker Leibinger GmbH & Co. KG and Steris as part of the overall 510(k) submission process. There is no information regarding the country of origin of the data beyond the company's location in Germany and the testing occurring at Steris. The data is retrospective in the sense that it was generated for the purpose of the 510(k) submission, not from a prospective clinical trial.

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

This section is not applicable as the studies performed were bench tests, not clinical studies requiring expert interpretation or ground truth establishment in a diagnostic context. The "ground truth" for these tests are the established standards and methodologies for biocompatibility, sterilization, and packaging tests.

4. Adjudication Method for the Test Set

This section is not applicable as the studies performed were bench tests. Adjudication methods are typically relevant for clinical studies where multiple expert opinions on a diagnosis or outcome are reconciled.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical mesh for surgical reconstruction; therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone "algorithm only" study was not done. The device is a physical medical implant, not an AI software or diagnostic algorithm.

The "ground truth" for the bench tests conducted is based on established industry standards and regulatory requirements for biocompatibility, sterilization, and packaging. For example, for "EtO Residuals Test," the ground truth would be that the residual levels of ethylene oxide must be below a specified regulatory limit. Similarly, for "Sterilization Validation," the ground truth is that the sterilization process achieves a predefined sterility assurance level (SAL).

8. Sample Size for the Training Set

This section is not applicable. This device is a physical implant, not an AI algorithm that requires a training set.

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

This section is not applicable as there is no training set for this device.

Summary

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November 6, 2018

Stryker Leibinger GmbH & Co. KG Gregory Gohl Sr. Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg, D-79111 De

Re: K182425

Trade/Device Name: Universal Mesh - Sterile Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, JEY Dated: September 5, 2018 Received: September 6, 2018

Dear Gregory Gohl:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Matthew C. Krueger -S

for 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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510(k) Summary

This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.

I. SUBMITTER

510(k) Owner:	Stryker Leibinger GmbH& Co. KGBoetzinger Strasse 41D-79111 Freiburg, Germany
Submitter/ ContactPerson:	Gregory GohlSr. Regulatory Affairs SpecialistStryker Craniomaxillofacial (CMF)750 Trade Centre WayPortage, MI 49002Phone: 269-389-4319Fax: 877-648-7114
Date prepared:	September 5, 2018

II. DEVICE [§807.92(a)(2)]

A. Neuro Branch Submission Device

Trade Name:	Universal Mesh - Sterile
Common or Usualname:	Bone Plate
ClassificationName:	Preformed alterable cranioplasty plate 21 CFR 882.5320
Regulatory Class:	Class II
Product Code:	GWO

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B. Dental Branch Submission Device

Trade Name:	Universal Mesh - Sterile
Common or Usualname:	Bone Plate
ClassificationName:	Bone Plate; 21 CFR 872.4760
Regulatory Class:	Class II
Product Code:	JEY

*Note the company Stryker or legacy name Stryker Leibinger precedes the product/trade name and predicate device in some documentation.

PREDICATE DEVICE [§807.92(a)(3)] III.

A. Neuro Branch Submission Device
Stryker Universal Mesh – K161821
B. Dental Branch Submission Device
Stryker Universal Mesh - K170773

DEVICE DESCRIPTION [§807.92(a)(4)] IV.

A. Neuro Branch Submission Device
The Universal Mesh - Sterile consists of an assortment of titanium meshes with different dimensions (small 60x60, medium 90x90, and large 120x120 mm) within the framework of the predicate Stryker Universal Mesh.

The design of the meshes is not changed. The only addition is to provide the meshes sterile in a suitable packaging system. These meshes are sterilized by exposure to Ethylene Oxide. The intended use, the principles of operation, and the materials of construction have not changed.

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B. Dental Branch Submission Device
The Universal Mesh – Sterile consists of an assortment of titanium meshes with different dimensions (small 60x60, medium 90x90, and large 120x120 mm) within the framework of the predicate Stryker Universal Mesh.

INDICATIONS FOR USE V.

A. Neuro Branch Submission Device

	Subject Device	Predicate Device – K161821
Indications forUse	The Universal Mesh is indicatedfor reconstruction, stabilization,and/or rigid fixation subsequentto craniotomy, craniectomy,cranioplasty, and cranial fracturesin adults and adolescents (age 12and higher).	The Universal Mesh is indicatedfor reconstruction, stabilization,and/or rigid fixation subsequent tocraniotomy, craniectomy,cranioplasty, and cranial fracturesin adults and adolescents (age 12and higher).

TABLE 5-1: COMPARISON OF INDICATIONS FOR USE

B. Dental Branch Submission Device

	Subject Device	Predicate - K170773
Indications forUse	The Universal Mesh is indicatedfor non-load-bearingreconstruction in themaxillofacial skeleton of patientsin whom skeletal growth iscomplete.	The Universal Mesh is indicatedfor non-load-bearingreconstruction in themaxillofacial skeleton of patientsin whom skeletal growth iscomplete.

TABLE 5-2: COMPARISON OF INDICATIONS FOR USE

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The subject device is compared to its predicate device for substantial equivalence of technological characteristics based on the following criteria:

A. Principles of Operation
B. Technological Characteristics

A. Principles of Operation / Operating Principle

The basic operational principle of the Universal Mesh - Cranial (K161821) and the secondary predicate device Universal Mesh- Dental (K170773) remains the same: the Stryker Universal Meshes are designed to aid in the reconstruction and stabilization (plus rigid fixation for the Neuro submission) of the bony areas of the cranial skeleton. The mesh can be modified by cutting and bending instruments for anatomical adaptation. The necessary instrumentation and related product storage are provided by the Stryker Universal Meshes.

B. Technological Characteristics

The fundamental scientific technology of the Universal Mesh - Sterile has not changed. This is because the design of the meshes has not changed. The only addition is to provide the meshes sterile in a suitable packaging system for sterile delivery. The intended use and principles of operation, as well as, materials of construction and operational characteristics have not changed.

-Intended Use: Same.
Materials of Construction: The subject meshes are manufactured out of the same material as the predicate device.
Mechanism of Action: Same. -
-Mode of Fixation: Same.
Packaging: The subject device is delivered sterile while the predicate device is dispensed non-sterile.

Overall, the change does not alter the subject device significantly and does not represent a new worst case in design.

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VII. PERFORMANCE DATA

Based on the Risk Analysis performed on the modifications to the Stryker Universal Mesh, bench testing was performed in support of the substantial equivalence determination.

There is no change in the design, material, manufacturing process, or duration/location of contact. The only change is to provide the meshes sterile by Ethylene Oxide sterilization. The performed tests were therefore designed to prove that the chosen packaging is suitable to encompass the meshes and maintain sterility. The performance of the sterilization cycle at Steris was evaluated, as well.

Performance Bench Testing

Characteristic	Test	Result
Biocompatibitily	EtO Residuals Test	Passed
Biocompatibitily	Cytotoxicity	Passed
Biocompatibitily	Endotoxin Testing	Passed
Biocompatibitily	Sterilization Validation	Passed
Biocompatibitily	Bioburden verification	Passed
Packaging Performance	Transportation Test	Passed
User Validation	System Handling Test	Passed

The following performance bench tests were completed.

The subject device met all pre-defined acceptance criteria and standards. The subject device was not found to represent a new worst-case. Overall, the results of the performance bench tests support the proposed substantial equivalence of the subject device.

Animal Testing

Animal testing was not required as a basis for substantial equivalence.

Clinical Testing

Clinical testing was not required as a basis for substantial equivalence.

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VIII. CONCLUSIONS

The results of the non-clinical data demonstrate that the modified Stryker Universal Mesh resulting in Universal Mesh - Sterile will perform as intended in the specified use conditions. The intended use, principles of operation, and fundamental scientific technology of the Universal Mesh - Sterile has not changed compared to the predicate device. This is because the design of the meshes has not changed. The only addition is to provide the meshes sterile in a suitable packaging system. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.

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).