The Stryker Facial iD Plating System is intended for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).

Specific Indications for Use:
-Orthognathic surgery
-Reconstructive maxillofacial surgery
-Mandible and maxillofacial trauma surgery.

Device Description

The Stryker Facial iD Plating System is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orthognathic surgery, reconstructive maxillofacial surgery, and mandible and maxillofacial trauma surgery.

The Subject Device plate(s) are additively manufactured patient-specific plates, and the patientspecific 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 a Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Model.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is present and what is not:

Acceptance Criteria and Device Performance (Based on provided text)

The document primarily states that the subject device (Stryker Facial iD Plating System, K193143) is substantially equivalent to its primary predicate device (Stryker Facial iD Plating System, K182305). The core of the acceptance criteria lies in demonstrating that the subject device performs as intended and is comparable to the predicate device, especially after software updates.

Acceptance Criteria Category	Reported Device Performance (K193143 vs. K182305)
Intended Use/Indications for Use	Identical
Principle of Operation	Identical
Fixation Method	Identical
Material	Identical
Non-Sterilization Method	Identical
Patient-Specific Offering	Identical
Design	Identical (bone plating system is identical)
Cleaning and Sterilization Validation	Identical (testing for K182305 is valid for K193143)
Biocompatibility Testing	Not necessary (no changes in material/process from K182305)
Performance Bench Testing (Mechanical Strength/Durability)	Performance test data shows substantial equivalence. Testing done for K182305 is valid.
End-User Performance	Performed as intended in specified use conditions (cadaver lab testing).
Software Verification and Validation	Performed according to internal procedures and IEC 62304. Met all predefined acceptance criteria.
Shipping and Handling	Testing done for K182305 is valid for K193143.

Detailed Study Information (Based on provided text)

A table of acceptance criteria and the reported device performance: See above table.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size:
  - For "Performance Bench Testing," "Cleaning and Sterilization," and "Shipping and Handling," the document states that data from the Primary Predicate Device (K182305) are "valid for the Subject Device." This implies that the sample sizes from the predicate device's testing were utilized, but the specific numbers are not provided in this document.
  - For the "end-user test validation in a cadaver lab," no specific sample size (number of cadavers or test cases) is mentioned.
- Data Provenance: Not specified for any of the inherited or new testing. The manufacturing facility is in Freiburg, Germany, which might imply the origin of some data, but it's not explicitly stated for any of the studies. The studies are essentially "retrospective" for the predicate device's data being applied to the new device. The cadaver lab testing would be "prospective" for the specific evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- The document mentions "end-user test validation of the Subject Device in a cadaver lab." This implies evaluation by medical professionals. However, the number of experts, their qualifications, or how a "ground truth" was established from their feedback is not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The document vaguely refers to "end-user test validation" but offers no details on assessment or adjudication methods for this or any other performance evaluation.
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:
- No, an MRMC comparative effectiveness study was not done. The device is a "Facial iD Plating System" (physical plates and associated software for design), not an AI-assisted diagnostic or interpretative system in the context of human "readers." The "software updates" mentioned are for "automated bone thickness measurements and visualization" and "plate design process improvements," aiding in the design of the physical plates, not directly assisting human "readers" in interpreting medical images or data for diagnosis.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document states "Software Verification and Validation testing were performed for the software updates" according to internal procedures and IEC 62304. This implies standalone testing of the software components. The new features like "automated bone thickness measurements and visualization" and "plate design process improvements" would have undergone testing in a standalone capacity to ensure they met their specified requirements. However, the specific metrics and results of this standalone testing are not detailed beyond the statement that they "met all predefined acceptance criteria."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the inherited bench testing from the predicate device, the ground truth would have been based on engineering specifications and established mechanical test standards.
- For the "end-user test validation in a cadaver lab," the ground truth likely involved expert assessment of surgical handling, fit, and intended performance by the medical professionals using the system, although how this "ground truth" was formally established (e.g., expert consensus) is not specified.
- For the software verification and validation, the ground truth would be against defined software requirements and expected outputs/behaviors.
The sample size for the training set:
- This device is a physical plating system with associated design software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense of supervised learning. Therefore, a "training set" as understood in AI/ML model development is not applicable here and is not mentioned in the document. The software updates are described as process improvements and automation of measurements, suggesting a rule-based or calculative approach rather than a learning algorithm trained on data.
How the ground truth for the training set was established:
- As a "training set" is not applicable, this question is not relevant to the information provided.

Summary

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March 26, 2020

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

Re: K193143

Trade/Device Name: Stryker Facial iD Plating System 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.

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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

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Indications for Use

510(k) Number (if known)

K193143

Device Name Stryker Facial iD Plating System

Indications for Use (Describe)

The Stryker Facial iD Plating System is intended for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).

Specific Indications for Use: -Orthognathic surgery -Reconstructive maxillofacial surgery

-Mandible and maxillofacial trauma surgery.

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

[X] Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

INTRODUCTION I.

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

SUBMITTER II.

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

Date prepared: March 26, 2020

DEVICE III.

Trade Name: Stryker Facial iD Plating System
Common or Bone Plating System Usual name:
Classification Bone Plate; 21 CFR §872.4760 name:
Regulatory Class: Class II

Product Code: JEY

IV. PREDICATE DEVICE

Primary Predicate: K182305, Stryker Facial iD Plating System Reference Device: K192192, VSP® System

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K193143

V. SUBJECT DEVICE DESCRIPTION

INDICATIONS FOR USE

	Subject Device,	Primary Predicate Device,
	K193143	K182305
IntendedUse/Indicationfor Use	The Stryker Facial iD PlatingSystem is intended for osteotomy,stabilization and rigid fixation ofmaxillofacial fractures andreconstruction in adults andadolescents (age 12 and higher).Specific Indication for Use:- Orthognathic Surgery- Reconstructivemaxillofacial surgery- Mandible andmaxillofacial traumasurgery	The Stryker Facial iD PlatingSystem is intended for osteotomy,stabilization and rigid fixation ofmaxillofacial fractures andreconstruction in adults andadolescents (age 12 and higher).Specific indication for Use:- Orthognathic surgery- Reconstructivemaxillofacial surgery- Mandible andmaxillofacial traumasurgery

Table 5- 1: Comparison Of Intended Use/Indications For Use.
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The Intended Uses and the specific Indication for Use of the Subject Device and Primary Predicate Device 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.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PRIMARY PREDICATE DEVICE

The Subject Device is compared to the Primary Predicate Device for substantial equivalence of technological characteristics based on the following criteria:

A. Principle of Operation
B. Technological Characteristics

A. Principle of Operation

The operating principle for the Subject Device is to reconstruct, stabilize and/or provide rigid fixation in the maxillofacial anatomy.

B. Technological Characteristics

The fixation method, material, non-sterilization method, patient-specific offering and design are identical when comparing the Subject and Primary Predicate Device. Most importantly, performance test data shows the Subject Device is substantial equivalent to the Primary Predicate Device.

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 System (K192192). Updates include automated bone thickness measurements and visualization, which aids in visualization for plate design and screw hole placement; and plate design process improvements (i.e., naming of files, cosmetic display). 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 Facial iD plates are not changing in any way compared to their previous clearance.

PERFORMANCE DATA 1.

The following performance testing to show substantial equivalency:

The Subject Device is identical to the 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 Primary Predicate Device.

Performance Bench Testing

Performance testing, cleaning and sterilization, shipping and handling done for the Primary Predicate Device in K182305 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 predefined 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.

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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 2.

The results of the performance tests demonstrate that the Subject Device, Stryker Facial iD Plating System will perform as intended in the specified use conditions. 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 of the Subject Device to the Primary Predicate Device.

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.