The Universal Mesh, which is the brand name of the subject device, consists of mesh implants in different sizes (40x40mm, 90x90mm, 120x120mm, 200x200mm), thicknesses (0.3mm, 0.6mm and 0.8mm), and perforation patterns, which include the 1.2mm and 1.5/ 1.7mm Dynamic Mesh pattern and Hybrid Mesh pattern. The meshes can be modified with trimming and bending instruments for an anatomical fit and are malleable for threedimensional adaptations. The mesh can be fixated to the bone with screws from the previously marketed Stryker CMF implant systems. In addition, the necessary instrumentation for mesh modification and storage is included with the system.

The implants of the Universal Mesh are provided non-sterile and are for single use only. The instrumentation and storage system is reusable.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Stryker Universal Mesh," which is a bone plate intended for non-load-bearing reconstruction in the maxillofacial skeleton. This is not an AI/ML device, and as such, the requested information pertaining to AI/ML device studies (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable and hence not present in the provided document.

However, I can extract information related to the acceptance criteria and the studies performed to demonstrate the device's substantial equivalence to a predicate device, as applicable to this medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility Testing	Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-18	Tests supported the biocompatibility of the device.
Lifetime Reprocessing	Internal acceptance criteria met	Internal acceptance criteria were met; tests were passed.
Cleaning Validation	Compliance with ISO 17664, AAMI TIR 30, AAMI TIR 12	Method validated.
Sterilization Validation	Compliance with ISO 14937, ISO 17664, ISO 17665, AAMI TIR 12, AAMI ST 81, AAMI ST79	Method validated.
Mechanical Performance Testing	Compliance with ASTM F382 against Primary Predicate Device	Acceptance criteria were met; tests were passed.
Corrosion Testing	Internal acceptance criteria met	Acceptance criteria were met; test was passed.
MR Compatibility	Compliance with FDA guidance for industry ("Assessment of Radiofrequency - Induced Heating" and "Establishing Safety and Compatibility of Passive Implants")	Labeled as MR Conditional based on evaluations.

Note: The document explicitly states that the "Subject device met all pre-defined acceptance criteria and standards and was found to not represent a new worst case."

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

Not applicable (N/A). This device is a physical medical implant (bone mesh), not an AI/ML software. The provided document details bench testing, not a clinical study involving a "test set" of patient data in the context of AI/ML evaluation. The tests were performed on the device itself or its materials.

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

N/A. As this is not an AI/ML device, the concept of "ground truth" established by experts for a test set of data does not apply in the same manner. Safety and effectiveness are demonstrated through adherence to recognized standards and comparative performance against a predicate device.

4. Adjudication method for the test set:

N/A. This is not relevant to the type of device and studies conducted.

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:

N/A. This device is not an AI system, so no MRMC study was performed.

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

N/A. This device is not an algorithm.

7. The type of ground truth used:

N/A. For this physical device, "ground truth" is established through adherence to engineering standards (e.g., ASTM F67, ASTM F382), biocompatibility standards (e.g., ISO 10993 series), and validated reprocessing/sterilization methods (e.g., ISO 17664, AAMI standards). The predicate device's established safety and effectiveness also serve as a comparative "ground truth" for substantial equivalence.

8. The sample size for the training set:

N/A. This is not an AI/ML device, hence no training set.

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

N/A. This is not an AI/ML device, hence no training set and no associated ground truth establishment method.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical performance bench tests and biocompatibility evaluations. These studies were conducted to demonstrate the substantial equivalence of the Universal Mesh to its primary predicate device (Universal CMF System - K022185).

The performance data included:

Biocompatibility Testing: Conducted according to FDA guidance and international standards (ISO 10993-1, ISO 10993-5, ISO 10993-18) to ensure the material (titanium conforming to ASTM F67) is safe for implantation.
Performance Bench Testing:
- Lifetime Reprocessing: Verified the ability of the device, instruments, and storage container to withstand reprocessing cycles per internal standards.
- Cleaning Validation: Verified the cleaning process as per ISO 17664, AAMI TIR 30, and AAMI TIR 12.
- Sterilization Validation: Validated sterilization instructions using standards like ISO 14937, ISO 17664, ISO 17665, AAMI TIR 12, AAMI ST 81, AAMI ST79.
- Mechanical Performance Testing: Included 4-point bending static and dynamic load tests according to ASTM F382, compared against the Primary Predicate Device, to ensure structural integrity and mechanical properties.
- Corrosion Testing: Verified the corrosion behavior of the subject device and associated components.
- MR Compatibility: Tested according to FDA guidance documents (e.g., "Assessment of Radiofrequency - Induced Heating" and "Establishing Safety and Compatibility of Passive Implants") to determine safe use in an MR environment.

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

Neither animal testing nor clinical testing was required as a basis for substantial equivalence for this particular device submission.

Summary

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November 8, 2017

Stryker Gregory Gohl Sr. Regulatory Affairs Specialist 750 Trade Centre Wav - Suite 200 Portage, Michigan 49002

Re: K170773

Trade/Device Name: Stryker Universal Mesh Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: October 11, 2017 Received: October 12, 2017

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about medical devices and radiation-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,

Mary S. Runner -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K170773

Device Name Universal Mesh

Indications for Use (Describe)

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

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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SECTION 5

510(k) Summary

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Section 5. 510(k) Summary

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

I. SUBMITTER [§807.92(a)(1)]

510(k) Owner:	Stryker Leibinger GmbH & Co. KGBoetzinger Strasse 4179111 Freiburg, Germany
Submitter/ ContactPerson:	Gregory GohlSr. Regulatory Affairs Specialist

Stryker Craniomaxillofacial 750 Trade Centre Way Portage, MI 49002 Phone: 269-389-4319 Fax: 877-648-7114

Date prepared: October 11, 2017

DEVICE [§807.92(a)(2)] II.

Trade Name:	Universal Mesh

Common or Usual Plate. Bone name:

Bone Plate; 21 CFR 872.4760 Classification name:

Regulatory Class: Class II

Product Code: JEY

PRIMARY PREDICATE DEVICE [§807.92(a)(3)] III.

Universal CMF System - K022185

A. REFERENCE DEVICE Universal Mesh - Cranial (K161821)
This submission is one of two submissions to the FDA for the subject Universal Mesh implants. The Universal Mesh with a dental indication (herein referred to as

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Universal Mesh - Dental) submission was originally submitted to the Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID), Dental Devices Branch (DEDB) in 2016. During substantive review of that submission and a hold Request for Additional information including a teleconference with the FDA on April 27, 2016, the FDA determined only the maxillofacial portion of the proposed craniomaxillofacial Indication for Use could be reviewed by DEDB. and that the cranial portion of the Indication for Use required a duplicate submission to the Division of Neurological and Physical Medicine Devices (DNPMD), Neurodiagnostic and Neurosurgical Devices Branch (NNDB). The resulting Universal Mesh with a cranial indication (K161821) has since been cleared, and for ease of review will be referenced as Universal Mesh - Cranial. During an April 27, 2016 teleconference with the FDA, it was discussed with Stryker that the use of the Universal CMF System (K022185) as the Primary Predicate Device in both submissions was possible based on the technological characteristics, overall intended use, and the history of the application. Each of these facts necessitated the present Universal Mesh - Dental submission.

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

The implants of the Universal Mesh are provided non-sterile and are for single use only. The instrumentation and storage system is reusable.

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V. INDICATIONS FOR USE [§807.92(a)(5 )]

TABLE 1: COMPARISON OF INDICATIONS FOR USE
	Subject Device	Primary Predicate Device—K022185
Indications forUse	The Universal Mesh is indicatedfor non-load-bearingreconstruction in the maxillofacialskeleton of patients in whomskeletal growth is complete.	The Stryker Leibinger UniversalCMF System is a Cranio-maxillofacial (CMF) plate andscrew system intended forosteotomy, stabilization and rigidfixation of CMF fractures andreconstruction.
	Subject Device	Primary Predicate Device-K022185
Principle ofOperation	the reconstruction of the bonyareas of the maxillofacial skeleton	the reconstruction of the bony areasof the maxillofacial skeleton
TechnologicalandOperationalCharacteristics
- Materials	titanium according to ASTM F67	titanium according to ASTM F67
- Mode ofFixation	implant fixation with screws	implant fixation with screws
- Mesh Pattern	screw holes connected via bars;for the Dynamic Mesh patterncountersinks were added to thescrew holes;	screw holes connected via bars
- MeshDesign/Sizes	Size: 40x40mm, 90x90mm,120x120mm, 200x200mmThicknesses: 0.3mm, 0.6mm,0.8mm	Size: 40x40mm, 90x90mm,120x120mm, 200x200mmThicknesses: 0.3mm, 0.6mm

TABLE 1: COMPARISON OF INDICATIONS FOR USE

The Primary Predicate Device is indicated for use in a range of anatomic areas (cranial, craniofacial skeleton, mid-face, maxilla, mandible) for a variety of surgical applications (craniofacial surgery, reconstructive procedures). The Indications for Use statement of the Universal Mesh falls within the scope of the broader Indications statement of the Primary Predicate Device. The differences in the Indications statement for the proposed device in comparison to the Primary Predicate Device does not constitute a new intended use.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PRIMARY PREDICATE DEVICE [§807.92(a)(6)]

The Universal Mesh is compared to its Primary Predicate Device for substantial equivalence based on the following criteria:

A. Principle of Operation
B. Technological and Operational Characteristics

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For both, Principle of Operation and Technological and Operational Characteristics, the Subject device and the Primary Predicate Device are equivalent. Deviations in regard to pattern shapes or mesh thickness do not alter the Subject device significantly, and it does not represent a new worst case in design.

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VII. PERFORMANCE DATA [§807.92(b)(1)]

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the Universal Mesh was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process", issued June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA. The tests supported the biocompatibility of the device.

The implant is made from titanium, which conforms to ASTM F67 for chemical composition, the same as the Primary Predicate Device. Cytotoxicity testing was performed using DIN EN 10993-5:2009. Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. Chemical characterization was performed using ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical Characterization of materials. The tests supported the biocompatibility of the device.

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Performance Bench Testing

Test	Test Method Summary	Results
Life timereprocessing	Verify the reprocessing life of the Subject device, instruments, andstorage container are according to internal standard.	Internal acceptancecriterion were met; testswere passed.
CleaningValidation	Verify the cleaning process for Subject device, instruments andstorage container are according to recommendations in ISO 17664,AAMI TIR 30, and AAMI TIR 12.	Method validated.
SterilizationValidation	Validate the sterilization instructions for the Subject device,instruments, and storage container are according to internal standard.Referenced standards: ISO 14937, ISO 17664, ISO 17665 - 1&2,AAMI TIR 12, AAMI ST 81, AAMI ST79.	Method validated.
MechanicalperformanceTesting	4 point-bending Static Load Test and Dynamic Load Test accordingto ASTM F382 against Primary Predicate Device.	Acceptance criterionwere met; tests werepassed.
CorrosionTesting	Verify corrosion behavior of Subject device, instruments, and storagedevice.	Acceptance criterionwere met; test waspassed.
MRCompatibility	Magnetic Resonance (MR) testing was performed on the subjectdevice mesh implants in accordance with FDA guidance for industry"Assessment of Radiofrequency - Induced Heating in the MagneticResonance (MR) Environment for Multi-Configuration PassiveMedical Devices," March 22, 2016. MR heat testing has beenperformed on the Subject device according to FDA final guidance"Establishing Safety and Compatibility of Passive Implants in theMagnetic Resonance (MR) Environment," December 11, 2014.	Based on the results ofthese evaluations, theimplants of theUniversal Mesh will belabeled as MRConditional.

The following performance bench tests were completed.

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

Animal Testing

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

Clinical Testing [§807.92(b)(2)]

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

VIII. CONCLUSIONS [§807.92(b)(3)]

The results of the non-clinical data demonstrate the Universal Mesh will perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.92 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.