The Stryker Customized Mandible Recon Plate Kit is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.
The Customized Mandible Recon Plate Kit is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction.

Device Description

The Subject Device, CMRP Kit (CMRP) is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions and is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction. The CMRP was cleared in K132519 and serves as an identical cleared Predicate Device, which shows the implant design software and design process, implant compatibility with the anatomical model, and the utilization of customized Guides which are similar to those offered for use with the Subject Device Stryker Customized Mandible Recon Plate Kit.

The Subject Device plate(s) are manufactured patient-specific plates, and the patient-specific design of the plates allows certain features to be configured to meet the individual needs of each patient. The Subject Device plate(s) are provided with the Design Proposal, an Instruction for Use (IFU), and an optional Anatomical Model. Additionally, the Subject Device is compatible with a separately provided Guides accessory.

AI/ML Overview

This 510(k) summary describes the Stryker Customized Mandible Recon Plate Kit, a device intended for surgical reconstruction of the mandible. The submission focuses on demonstrating substantial equivalence to a predicate device already on the market, particularly given a software update and compatibility with another system.

Here's an analysis of the acceptance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria and reported device performance in the format requested. Instead, it states that the "subject device met all pre-defined acceptance criteria as the primary predicate device," indicating that the acceptance criteria are implicitly linked to the performance of the predicate device.

The reported device performance is described generally: "the results of the tests support the substantial equivalence of the subject device to the primary predicate device." More specifically, the cadaver lab testing "showed that the subject device is performing as intended in the specified use conditions."

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "performance testing in the cadaver lab." However, it does not specify the sample size (i.e., number of cadavers) used for this test set nor does it explicitly state the provenance of the data (e.g., retrospective or prospective).

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the cadaver lab testing. It simply refers to "end-user test validation."

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for the test set.

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

An MRMC comparative effectiveness study was not performed or mentioned in this submission. The device is a physical bone plate kit and not an AI-assisted diagnostic tool that would typically involve such a study.

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

A standalone performance study in the context of an algorithm without human-in-the-loop performance is not applicable or described for this physical device. The software update mentioned is related to design and visualization, not an autonomous diagnostic algorithm.

7. Type of Ground Truth Used:

For the cadaver lab testing, the ground truth was likely established through direct observation and assessment by surgical end-users of the device's performance in physically reconstructing the mandible. This would involve evaluating how well the customized plates fit, the stability of the fixation, and ease of use in a realistic surgical environment.

8. Sample Size for the Training Set:

The concept of a "training set" in the context of machine learning is not applicable here as this is a physical medical device. While software updates are mentioned for automated bone thickness measurements and visualization, the document does not detail any machine learning models that would require a distinct training set. The software was subject to "Software Verification and Validation testing."

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

As mentioned above, the concept of a training set is not directly applicable. For the software verification and validation, the "ground truth" would be established through predefined software requirements and specifications, and the validation would verify that the software outputs (e.g., bone thickness measurements, visualization) accurately reflect the design intent and input data. These tests were performed "according to internal procedures and IEC 62304."

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 26, 2020

Stryker Zainab Amini Senior Regulatory Affairs Specialist 750 Trade Centre Way- Suite 200 Portage, Michigan 49002

Re: K193136

Trade/Device Name: Stryker Customized Mandible Recon Plate Kit Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: February 27, 2020 Received: February 28, 2020

Dear Zainab Amini:

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. Although this letter refers to your product as a device, please be aware 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.

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K193136

Device Name Stryker Customized Mandible Recon Plate Kit

Indications for Use (Describe)

The Customized Mandible Recon Plate Kit is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.

The Customized Mandible Recon Plate Kit is indicated for use in primary mandbular reconstruction with bone graft. temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary510(k) Summary

INTRODUCTION I.

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

II. SUBMITTER

510(k) Owner:	Stryker Leibinger GmbH& Co. KGBoetzinger Strasse 41D-79111 Freiburg, Germany
Submitter/Contact Person:	Zainab AminiSenior Regulatory Affairs Specialist
Contact Person:	Senior Regulatory Affairs SpecialistStryker Craniomaxillofacial750 Trade Centre WayPortage, MI 49002Phone: 269-389-8349Fax: 877-648-7114

Date prepared: March 26, 2020

III. DEVICE

Trade Name:	Stryker Customized Mandible Recon Plate Kit
Common orUsual name:	Bone Plating System
Classificationname:	Bone Plate; 21 CFR §872.4760

Regulatory Class II Class:

Product Code: JEY

IV. PREDICATE DEVICE

Primary Predicate: K132519, Stryker Customized Mandible Recon Plate Kit Reference Device: K192192, VSP® System

{4}------------------------------------------------

V. SUBJECT DEVICE DESCRIPTION

INDICATIONS FOR USE

Table 5- 1: Comparison of Indication For Use.

	Subject Device,K193136	Predicate Device,K132519
IntendedUse/ andIndicationsfor Use	The Stryker Customized MandibleRecon Plate Kit is intended to be usedfor rigid internal fixation of primaryand secondary mandibularreconstructions.The Customized Mandible Recon PlateKit is indicated for use in primarymandibular reconstruction with bonegraft, temporary bridging until delayedsecondary reconstruction andsecondary mandibular reconstruction.	The Stryker Customized MandibleRecon Plate Kit is intended to be usedfor rigid internal fixation of primaryand secondary mandibularreconstructions.The Customized Mandible Recon PlateKit is indicated for use in primarymandibular reconstruction with bonegraft, temporary bridging until delayedsecondary reconstruction andsecondary mandibular reconstruction.

The Intended Uses and Indication for Use of both, the Subject and Predicate Devices are identical.

Reference Device: K192192, VSP® System - Patient specific maxillofacial anatomical models, templates, guides, and surgical plans. This is added for compatibility to the Subject Device. Information regarding this reference device is not necessary for the substantial equivalence comparison.

The purpose of this Special 510(k) submission is due to Stryker's software update, and additionally, to show compatibility of the Subject Device implants with the VSP System cleared in K192192.

{5}------------------------------------------------

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Subject Device Stryker Customized Mandible Recon Plate Kit is based on the following criteria:

A. Principle of Operation
B. Technological Characteristics

A. Principle of Operation

The basic operational principle of the Stryker Customized Mandible Recon Plate Kit is the stabilization of mandibular reconstruction.

B. Technological Characteristics

The technological characteristics of Subject Device remain the same as the Predicate Device. Stryker Customized Mandible Recon Plate Kit (CMRP) is for the reconstruction or bridging of mandible resection, and area of the application is mandible.

The bone plating system of the primary predicate device and the subject device remain identical. This 510(k) includes a software updates and shows compatibility to the VSP Svstem (K192192). Updates include automated bone thickness measurements and visualization. Software Verification and Validation testing were performed for the software updates. As shown in the performance testing in the cadaver lab, the interaction between the surgical guides and the Subject Device plates are not changing in any way compared to their previous clearances.

VII. PERFORMANCE DATA

The following performance testing to show substantial equivalency:

The Subject Device is identical to primary Predicate Device for cleaning and sterilization validation. Additionally, biocompatibility testing is not necessary for the Subject Device as there have been no changes in the Subject Device material and process, and therefore the Subject Device is identical to the Predicate Device.

Performance Bench Testing

Performance testing, cleaning and sterilization, shipping and handling done for the Primary Predicate Device in K132519 are valid for the Subject Device. The end-user test validation of the Subject Device in a cadaver lab showed that the subject device is performing as intended in the specified use conditions. Software verification and validation were performed according to internal procedures and IEC 62304. Therefore, the subject device met all pre-defined acceptance criteria as the primary predicate device, and the results of the tests support the substantial equivalence of the subject device to the primary predicate device.

{6}------------------------------------------------

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.

CONCLUSIONS VIII.

The results of the performance testing demonstrate the Subject Device, Stryker Customized Mandible Recon Plate 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.