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 mandibular reconstruction with bone graft, temporary bridging until delaved secondary reconstruction and secondary mandibular reconstruction.

Device Description

The Customized Mandible Recon Plate Kit includes customized, patient specific implants, the Customized Mandible Recon Plates. Additionally, the kit includes the Instruction for Use (IFU) and a printed version of the Design Proposal approved by the surgeon prior to plate manufacture. It may include an anatomical model, named Mandible Model. The Customized Mandible Recon Plates (CMRP) and the corresponding Mandible Model are designed and manufactured for one specific patient. The products are ordered by a surgeon on a patient-by-patient basis over an internet platform referred to as the "eRequest Lifecycle online ordering system" which was already cleared with K111065 for ordering patient specific polymer implants to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone. Based on patient specific anatomical data (CT-scan) and input from the surgeon, a virtual mandible recon plate with its specific dimensions (profile heights, length and 3D run of the plate, number and position of screw holes and bar strengthening) is created using the Customized Mandible Recon Plate Design Process (CMRP-DP) including the Plate Design Software (PDS). Screenshots of the virtual plate are then presented to the surgeon in the Design Proposal (pdf-file). After the surgeon approves the Design Proposal via the above mentioned eRequest Lifecycle online ordering system, the Customized Mandible Recon Plate, as well as the Mandible Model (if ordered by the surgeon), are manufactured according to the specifically set design requirements. Once the manufacturing process is finalized and the devices are cleaned, they are packed, labeled and shipped to the location specified during the ordering process. The CMRP implant is compatible with the Stryker Universal Mandibular System. Additionally. Stryker offers customized cutting and drill guides for use with the Customized Mandible Recon Plate.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Stryker Customized Mandible Recon Plate Kit:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary explicitly states that: "The Subject Device fulfilled all set acceptance criteria for each category in accordance with either ISO or ASTM specifications, or internally predetermined acceptance criteria if no standards were applicable."

Unfortunately, the document does not provide specific quantitative acceptance criteria values or detailed quantitative device performance results for each test. It only lists the categories of tests performed and the relevant standards. Therefore, I can only provide a table with the types of tests and the general outcome reported.

Acceptance Criteria Category	Reported Device Performance	Relevant Standards (where stated)
Biocompatibility	Met acceptance criteria	DIN EN ISO 10993 ff as valid 2013 (Part 1)
Cleaning Validation	Met acceptance criteria	EN ISO 15883-1:2009, DIN EN ISO 17664:2004
Sterilization (validation)	Met acceptance criteria	ISO 11138-1:2006, DIN EN ISO 11737-1:2009, DIN EN ISO 11737-2:2009, DIN EN ISO 14161:2011, DIN EN ISO 14937:2009, DIN EN ISO 17665-1:2006, DIN ISO/TS 17665-2:2009
Multiple Reprocessing	Met acceptance criteria	(Standards for sterilization and cleaning are implied)
Residual Moisture after Sterilization	Met acceptance criteria	(Implied by sterilization standards)
MRI Conditional	Met acceptance criteria	(Standard not explicitly listed, but implied)
Transportation Validation	Met acceptance criteria	(Standard not explicitly listed)
Clinical Transportation	Met acceptance criteria	(Standard not explicitly listed)
Mechanical Strength of Plate	Met acceptance criteria	ASTM or internally predetermined criteria
Mechanical Strength of Locking Mechanism between Plate and Screw	Met acceptance criteria	ASTM or internally predetermined criteria
Handling of System (End User & End Product Test)	Met acceptance criteria	(Standard not explicitly listed, likely internal)

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

The document does not specify the sample sizes used for the non-clinical tests. It also does not discuss data provenance in terms of country of origin or whether the data was retrospective or prospective, as these non-clinical tests typically involve laboratory testing of manufactured devices or materials, not patient data in the conventional sense.

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

This information is not applicable to the non-clinical performance and V&V testing described. "Ground truth" in this context refers to clinical outcomes or diagnoses, which were not part of this submission's evidence for efficacy. For mechanical and biocompatibility testing, the "ground truth" is defined by the standards (ISO, ASTM) themselves or internal specifications.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers assess cases and their disagreements need to be resolved. The tests described are laboratory-based conformance tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. The document explicitly states: "No clinical testing was performed to support this submission." Therefore, no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No. This device is a physical medical implant (a bone plate) and associated design/manufacturing process, not an algorithm or AI software for diagnosis or analysis. The "Plate Design Software (PDS)" is part of the design process, but its performance wasn't evaluated as a standalone AI diagnostic tool.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is the established acceptance limits defined by international standards (ISO, ASTM) or internal predetermined specifications. For example, a biocompatibility test result must fall within the range deemed safe by ISO 10993, and mechanical strength must exceed certain load thresholds.

8. The Sample Size for the Training Set

Not applicable. The device is a physical implant and manufacturing process. There is no concept of a "training set" as one would have for a machine learning algorithm. The design process for each plate is customized based on patient-specific CT data and surgeon input, but this is not a learning algorithm that requires a "training set" of cases to develop its core function.

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

Not applicable, as there is no "training set" for this device. The design process (CMRP-DP including PDS) relies on established engineering principles, CAD/CAM software, patient-specific imaging data (CT-scan), and surgeon input, rather than a machine learning model trained on a ground-truthed dataset.

Summary

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K 132519 DEC - 6 2013

র বাবা পারে আর মাধ্যমে স

510(k) Summary
Date prepared:	August 5, 2013
Submitter:	Stryker Craniomaxillofacial750 Trade Center WayPortage, MI 49002USA
Contact:	Rob YamashitaPhone: (269) 389-4258 / Fax: (269) 329-2235rob.yamashita@stryker.com
Proprietary Name:	Stryker Customized Mandible Recon Plate Kit
Common Name:	Bone Plate
Proposed Regulatory Class:	Class II
Product Codes:	JEY
Predicate Device:	Predicate devices for intended use, indications for use, andtechnical characteristics are:
	1. Stryker NewGen/Universal Mandibular System - K0142632. Synthes Patient Specific Plates - K122647
	The predicate device for the patient-specific ordering,designing, and logistics process is:
	3. Stryker PEEK Customized Cranial Implant Kit - K121153
Intended Use:	The Customized Mandible Recon Plate Kit is intended to beused for rigid internal fixation of primary and secondarymandibular reconstructions.
Indication for Use:	The Customized Mandible Recon Plate Kit is indicated foruse in primary mandibular reconstruction with bone graft,temporary bridging until delayed secondary reconstructionand secondary mandibular reconstruction.

. . . . .

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. * :

Device Description:

The Customized Mandible Recon Plates (CMRP) and the corresponding Mandible Model are designed and manufactured for one specific patient. The products are ordered by a surgeon on a patient-by-patient basis over an internet platform referred to as the "eRequest Lifecycle online ordering system" which was already cleared with K111065 for ordering patient specific polymer implants to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone. Based on patient specific anatomical data (CT-scan) and input from the surgeon, a virtual mandible recon plate with its specific dimensions (profile heights, length and 3D run of the plate, number and position of screw holes and bar strengthening) is created using the Customized Mandible Recon Plate Design Process (CMRP-DP) including the Plate Design Software (PDS).

Screenshots of the virtual plate are then presented to the surgeon in the Design Proposal (pdf-file). After the surgeon approves the Design Proposal via the above mentioned eRequest Lifecycle online ordering system, the Customized Mandible Recon Plate, as well as the Mandible Model (if ordered by the surgeon), are manufactured according to the specifically set design requirements. Once the manufacturing process is finalized and the devices are cleaned, they are packed, labeled and shipped to the location specified during the ordering process.

The CMRP implant is compatible with the Stryker Universal Mandibular System. Additionally. Stryker offers customized cutting and drill guides for use with the Customized Mandible Recon Plate.

Technological and Operational Characteristics:

The Stryker Customized Mandible Recon Plate Kit is similar to its Predicate Devices in the following technological and operational characteristics:

Material: ●
●

The Subject Device is made of biocompatible commercially pure titanium (CP Ti Grade 2); Predicates 1 and 2 are made of pure titanium.

Desian:

The transfer of CT patient data to a manufacturing process resulting in an individualized implant fulfilling the specific requirements of the patient is identical to the subject device and Predicate 3 and similar to Predicate 2.

The final patient specific plate for mandibular reconstruction itself is similar to the stock plates of Predicate Device 1. Predicate Device 2 provides patient specific plates for mandibular

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reconstruction, therewith being similar to the Subject Device.

The Subject Device is offered in 2.0mm and 2.8mm profile height, whereas the Predicate Devices 1 and 2 range from 1.5mm to 2.8mm profile height.

The basic operational principle of the Subject Principal of . Device, as well as Predicate Devices 1 and 2, is Operation: the stabilization of mandibular reconstruction. The method of site preparation and fixation are identical for both the Subject Device and the referenced Predicate Devices.
The Subject Device and all Predicate Devices are Packaging: . delivered non-sterile.

Clinical Testing:

No clinical testing was performed to support this submission.

Non-Clinical Testing:

The Stryker Customized Mandible Recon Plate Kit proved to meet acceptance criteria in evaluations conducted for biocompatibility, cleaning, sterilization, multiple all reprocessing, residual moisture after sterilization, MRI conditional, transportation, clinical transportation, mechanical strength of plate, mechanical strength of locking mechanism between plate and screw and handling of system (end user & end product test).

Substantial Equivalence to Predicate Devices:

The Stryker Customized Mandible Recon Plate Kit combines the princibles of individualized design configuration with the PEEK Customized implant as one of the predicate devices and the principles of operation with the other two Predicate Devices 1 and 2. Its intended use and its indications for use are nearly identical to these. Material and technological characteristics are similar to the legally marketed Predicate Devices 1 and 2. The ordering, design and logistical process of the Subject Device is nearly identical to the one of Predicate Device 3.

Performance Testing:

Verification and Validation (V&V) evaluation has been performed on the Subject Device in the following categories: biocompatibility, cleaning validation validation, multiple reprocessing, residual moisture after sterilization, MRI conditional,

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transportation validation, clinical transportation, mechanical strength of plate, mechanical strength of locking mechanism between plate and screw, and handling of system (end user & end product test). The Subject Device fulfilled all set acceptance criteria for each category in accordance with either ISO or ASTM specifications, or internally predetermined acceptance criteria if no standards were applicable. All applied ISO standards are listed below.

... _ .

Reference	Title
Biocompatibility
DIN EN ISO 10993 ff asvalid 2013	Biological evaluation of medical devices. Part 1:Evaluation and testing within a risk managementsystem
Sterility/Reprocessing
ISO 11138-1:2006	Sterilization of health care products - Biologicalindicators - Part 1: General requirements
DIN EN ISO 11737-1:2009	Sterilization of medical devices - Microbiologicalmethods - Part 1: Determination of a population ofmicroorganisms on products
DIN EN ISO 11737-2:2009	Sterilization of medical devices - Microbiologicalmethods - Part 2: Tests of sterility performed in thevalidation of a sterilization process
DIN EN ISO 14161:2011	Sterilization of health care products - Biologicalindicators - Guidance for the selection, use andinterpretation of results
DIN EN ISO 14937:2009	Sterilization of health care products - general criteriafor characterization of a sterilizing agent anddevelopment, validation and routine control of asterilization process
EN ISO 15883-1:2009	Washer-disinfectors: General requirements, termsand definitions and tests
DIN EN ISO 17664:2004	Sterilization of medical devices - Information to beprovided by the manufacturer for the processing ofresterilizable medical devices
DIN EN ISO 17665-1:2006	Sterilization of health care products - Moist heat -Part 1: Requirements for the development, validationand routine control of a sterilization process formedical devices
DIN ISO/TS 17665-2:2009	Sterilization of health care products - Moist heat -Part 2: Guidance on the application of ISO 17665-1

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, with three flowing lines representing the department's mission to promote health and well-being.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 6, 2013

Stryker Craniomaxillofacial Mr. Rob Yamashita Associate Manager, Regulatory Affairs 750 Trade Center Way Ste 200 Portage, MI 49002

Re: K132519

Trade/Device Name: Stryker Customized Mandible Recon Plate Kit Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Il Product Code: JEY Dated: October 22, 2013 Received: November 4, 2013

Dear Mr. Yamashita:

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.

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Page 2 - Mr. Yamashita

Station of Contract

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) 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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer -S for

Erin I. Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Device and Radiological Health

Enclosure

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Stryker Customized Mandible Recon Plate Kh

Craniomaxillofacial

510(k) Number (if known):

Device Name:

Indications For Use:

Stryker Customized Mandible Recon Plate Kit

K132519

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 mandibular reconstruction with bone graft, temporary bridging until delaved secondary reconstruction and secondary mandibular reconstruction.

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)

Traditional 610(k)

Mary S. Runner -: 2013.12.04 14:22:00 -05'00'

Page 23 of 655

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.