The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing.

The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.

Device Description

The Stryker Universal SMARTLock Hybrid MMF System is a maxillomandibular fixation system that consists of a pure titanium fixation Plate, 2 self-drilling locking Screws made out of titanium alloy (6mm and 8mm), a bending instrument and a spacing instrument. These devices are stored in a dedicated module and in a dedicated generic instrument tray, respectively. Both the tray and the module are stored in a generic storage container.

The Plate has in-plane bendable attachment loops for screw fixation on either the maxilla or mandible. The fixation loops can be bent with the Bender. The locking screw fixation together with use of the Spacer is designed to prevent pressure on the gingiva from the fixated Plate.

AI/ML Overview

The provided text describes a medical device, the "Stryker Universal SMARTLock Hybrid MMF System," and its submission for FDA 510(k) clearance. However, it explicitly states that no clinical testing was performed to support this submission. Therefore, it is based on non-clinical testing and substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through clinical performance.

Due to the lack of clinical testing, the requested information regarding acceptance criteria derived from a clinical study, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies cannot be provided from this document.

Here's what can be extracted based on the "Non-Clinical Testing" section:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Acceptance Criteria Category	Reported Device Performance (Non-Clinical)
Biocompatibility	Successful
Cleaning	Successful
Screw Insertion	Successful
Corrosion Resistance	Successful
Mechanical Stability of Construct	Successful
Locking Test	Successful
System Handling Test	Successful
End-User (Cadaver) Test	Successful

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

Sample Size: Not specified (since clinical testing was not performed). For non-clinical tests, specific sample sizes (e.g., number of cadavers, number of screws tested) are not detailed.
Data Provenance: Not applicable for clinical data. For non-clinical testing, it would originate from in vitro laboratory tests or cadaveric testing conducted by Stryker Craniomaxillofacial.

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

Not applicable, as no clinical test set for ground truth establishment was used.

4. Adjudication method for the test set:

Not applicable, as no clinical test set with human assessments requiring adjudication was used.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a physical fixation system, not an AI-assisted diagnostic tool involving "human readers."

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

Not applicable, as this is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" would be established by engineering and material science standards (e.g., material specifications for biocompatibility, force thresholds for mechanical stability, established protocols for cleaning validation, successful insertion without damage).

8. The sample size for the training set:

Not applicable, as no algorithm or AI required a training set.

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

Not applicable, as no algorithm or AI required a training set.

Summary based on the provided text:

The Stryker Universal SMARTLock Hybrid MMF System gained 510(k) clearance based on non-clinical testing that demonstrated success in various physical and mechanical properties, and its substantial equivalence to existing predicate devices (Stryker MMF Screw – K050535 and KLS Martin Erich Arch Bar – K061271). No clinical studies or any form of human-in-the-loop or standalone AI performance evaluation were conducted or documented in this submission.

Summary

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Stryker Universal SMARTLock Hybrid MMF System

Image /page/0/Picture/1 description: The image shows the word "stryker" in black font. The font is bold and sans-serif. There is a small "c" in superscript to the right of the word. The word is likely a logo or brand name.

Craniomaxillofacial

1ﮨﮯt	( CC10S	(SI

510(k) Summary

Date prepared:	July 31, 2012	OCT 31 20
Submitter:	Stryker Craniomaxillofacial750 Trade Center WayPortage, MI 49002USA
Contact:	Rob YamashitaPhone: (269) 389-4258 / Fax: (269) 329-2235rob.yamashita@stryker.com
Proprietary Name:	Stryker Universal SMARTLock Hybrid MMF System
Common Name:	Universal Hybrid MMF
Proposed Regulatory Class:	Class II
Product Codes:	DZL – Intraosseous fixation screw or wireJEY – Bone Plate
Predicate Device:	Stryker MMF Screw – K050535KLS Martin Erich Arch Bar – K061271

Intended Use:

Indication for Use:

The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and ad olescents (age 12 and higher) in whom permanent teeth have erupted.

Device Description:

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Craniomaxillofacial

Technological Characteristics:

The Stryker Universal SMARTLock Hybrid MMF System is similar to its Predicate Devices in the following technological characteristics:

The Stryker Universal SMARTLock Hybrid HMMF Material: . System is made of either commercially pure titanium or titanium alloy. The Predicate Devices are made of stainless steel. The Stryker Universal SMARTLock Hybrid MMF Design: . System is a c ombination of the legally marketed MMF Screw System (K050535) and Erich Arch Bar (K061271).
Inter-radicular Screw Fixation or Circumferential Mode of Fixation: . wiring of dentures or teeth as with the Predicate Devices (K050535, K061271).
With ligature wires as with the Predicate Devices Intermaxillary . (K050535, K061271). Stabilization:
The devices of the Stryker Universal SMARTLock Packaging: . Hybrid MMF System are delivered non-sterile as are the Predicate Devices.

Clinical Testing:

No clinical testing was performed to support this submission.

Non-Clinical Testing:

The Stryker Universal SMARTLock Hybrid MMF System proved to be successful in all the tests conducted with regards to biocompatibility, cleaning, screw insertion, corrosion resistance, mechanical stability of construct, locking test, a system handling test and an end-user (cadaver) test.

Substantial Equivalence to Predicate Devices:

The Stryker Universal SMARTLock Hybrid MMF System combines the principles of operation of the Predicate Devices. It has nearly identical intended use and indications. Material and technological characteristics are similar to the legally marketed Predicate Devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Public Health Service

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

OCT 31 2012

Stryker® Craniomaxillofacial Mr. Rob Yamashita Associate Manager, Regulatory 750 Trade Centre Way, Suite 200 Portage, Michigan 49002

Re: K122313

Trade/Device Name: Stryker Universal SMART Lock Hybrid MMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZL Dated: July 19, 2012 Received: August 2, 2012

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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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 (21 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

ph for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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):

K122313

Device Name:

Indications For Use:

Stryker Universal SMARTLock Hybrid MMF System

× 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)

Susan Runon

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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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.