The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.

Device Description

The Stryker Universal Orbital Floor System comprises a pre-bent titanium orbital floor implant that approximates the shape and dimensions of the average normal orbital floor and medial wall (in order to facilitate the operative goal of restoring normal (pretraumatic) orbital volume as accurately as possible), a globe retractor for retraction of the orbital contents off the orbital floor and walls (in order to provide exposure of the fracture site(s)), and a plate-holding forceps (that facilitates the insertion and positioning of the plate within the orbit).

The plates are designed based on an average anatomical model of CT-scan data taken from 300 subjects (92% Caucasian). The metadata of the 300 subjects that have been included in the generation of the average anatomical model is listed in table 1. The selected scans were obtained from healthy subjects without any deformation of the bony orbital structures.

The implant is provided in pre-bent left and right and in small and large sizes. A medial wall extension is attached to the floor section of the implant in order to provide coverage for a co-extensive medial wall fracture. If not needed, this medial wall extension may be removed by cutting through the designated cutting lines on the implant. The implant is fixed to the infra-orbital rim via either the holes on the provided fixation arms or through the anterior screw holes on the plate itself.

AI/ML Overview

The provided document is a 510(k) summary for the Stryker Universal Orbital Floor System, a medical device. It does not describe acceptance criteria or a study proving that the device meets acceptance criteria in the typical sense of a performance evaluation with metrics like sensitivity, specificity, accuracy, etc.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is the primary pathway for 510(k) clearance. This means the "study" is a comparison to an already legally marketed device, and the "acceptance criteria" are effectively the requirements for demonstrating this equivalence.

Here's an analysis based on your request, with the understanding that the document's content is geared towards substantial equivalence rather than performance metrics:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence, the "acceptance criteria" are the characteristics of the predicate device that the new device must be substantially equivalent to, and the "performance" is how the new device compares.

Criteria Category	Acceptance Criteria (Predicate Device Characteristics)	Reported Device Performance (Subject Device Characteristics)
Intended Use	Reconstruction of orbital floor and/or medial wall; Indicated for trauma repair and reconstruction of craniofacial skeleton, including orbital floor/medial wall fractures.	Same Intended Use: reconstruction of orbital floor and/or medial wall; Same Indications for Use: reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients (predicate did not specify age).
Principle of Operation	Reconstruct the orbital floor and/or medial wall; plate fixation with screws inserted through dedicated screw holes; Permanent implant.	Same Principle of Operation: Reconstruct the orbital floor and/or medial wall; plate fixation with screws inserted through dedicated screw holes; Permanent implant.
Material	Pure Titanium	Commercially Pure Titanium (CP Ti Grade 2)
Design	3D pre-bent plate based on average anatomical model; 0.4mm thickness; Based on average anatomical model of 279 Caucasian CT-scans.	3D pre-bent plate based on average anatomical model; 0.4mm thickness; Based on average anatomical model of 300 CT-scans (92% Caucasian, i.e., 276 Caucasian subjects).
Mode of Modification	Cutting/trimming along dedicated lines; pliable mesh structure for bending.	Same: Cutting/trimming along dedicated lines; pliable mesh structure for bending.
Sizes	2 sizes: large and small for left and right each.	Same: 2 sizes: large and small for left and right each.
Dimensions	Large Plate: L=35mm, W=38mm, H=18mm; Small Plate: L=31mm, W=34mm, H=10mm.	Large Plate: L=35mm, W=36mm, H=16mm; Small Plate: L=31mm W=34mm, H=12mm. (Slight dimension differences, deemed substantially equivalent due to overall design and function similarity).
Screw Holes	For 1.5 mm and 1.8 mm screws; 4 screw holes along rim; Two screw fixation arms with 2 screw holes each; Position of screw fixation arms at 1st and 2nd screw hole from medial.	For 1.2 mm, 1.4 mm and 1.7 mm screws; 4 screw holes along rim; Two screw fixation arms with 2 screw holes each; Position of screw fixation arms at 1st and 3rd screw hole from medial. (Differences in screw size compatibility and arm position, deemed acceptable).
Packaging	Non-sterile and sterile.	Non-sterile. (Difference noted, but likely a matter of processing rather than fundamental safety/effectiveness, as sterilization would occur prior to use).

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

Test Set: N/A for a performance study. Clinical testing was not performed.
Design Basis (similar to a "development" or "validation set" for anatomical design): The implant's design is based on an "average anatomical model of CT-scan data taken from 300 subjects."
Data Provenance: The document explicitly states "92% Caucasian" for this group of 300 subjects, implying a predominantly Caucasian population. The country of origin for these CT scans is not specified. The scans were "obtained from healthy subjects without any deformation of the bony orbital structures." This is retrospective data used for design purposes.

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

N/A. No clinical testing or expert-adjudicated ground truth for a "test set" in the context of device performance was conducted. The device's design (not its performance against clinical outcomes) was derived from anatomical data.

4. Adjudication Method for the Test Set

N/A. No test set requiring adjudication was performed.

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

No MRMC comparative effectiveness study was done.
No human readers were involved in a comparative effectiveness study of the device itself.

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

This question is not applicable. This is a physical implant device, not an algorithm or software. Its performance is related to its mechanical properties and anatomical fit, not an "algorithm-only" evaluation.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the design of the device, the 'ground truth' was an "average anatomical model of CT-scan data" which represents a statistical average of healthy orbital structures. This is anatomical data, not clinical outcomes or expert consensus on disease.

8. Sample Size for the Training Set

N/A in the context of machine learning. If we interpret "training set" as the data foundational to the device's design, it would be the 300 CT scans used to create the average anatomical model.

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

The "ground truth" (the average anatomical model) for the design was established by analyzing CT-scan data from 300 subjects. These were "healthy subjects without any deformation of the bony orbital structures." The metadata included age (average 59 years), gender (122 female, 178 male), and ethnic group (276 Caucasians, 3 Middle-East, 21 unknown). The specific methodology for generating the "average anatomical model" from these scans (e.g., statistical averaging, landmark registration) is not detailed beyond stating it was an "average" model.

Summary

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K123726

stryker®

510(k) Summary		APR 0 9 2013
Date prepared:	December 6, 2012
Submitter:	Stryker Leibinger GmbH & Co. KGBötzinger Straße 4179111 Freiburg.Germany
Contact:	Jamshed BadarpuraPhone: (269) 389-4260jamshed.badarpura@stryker.com
	Stryker Craniomaxillofacial750 Trade Center WayPortage, MI 49002USA
Proprietary Name:	Stryker Universal Orbital Floor System
Common Name:	Universal Orbital Floor
Proposed Regulatory Class:	Class II
Product Codes:	JEY - Bone Plate
Predicate Device:	Synthes Craniofacial Plate and Screw System -K080331

Intended Use:

The Stryker Universal Orbital Floor System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.

Indication for Use:

The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.

Device Description:

Traditional 510(k)

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stryker®

the orbital contents off the orbital floor and walls (in order to provide exposure of the fracture site(s)), and a plate-holding forceps (that facilitates the insertion and positioning of the plate within the orbit).

Table 1: Meta data of the 300 CT scans

Image /page/1/Figure/5 description: This image shows a table of data organized by age, gender, and ethnic group. The age ranges are in increments of 10 years, from 10-19 to 90-99. For the age range of 10-19, there are 18 people, 122 females, and 276 people in the 'ca' ethnic group. The average age is 59 years.

Gender: 122 female (f) and 178 male (m);

Ethnic Group: 276 Caucasians (ca), 3 Middle-East (me), 21 unknown (xx)

Clinical Testing:

No clinical testing was performed to support this submission.

Non-Clinical Testing:

The Stryker Universal Orbital Floor System was subjected to Verification and Validation testing of biocompatibility, cleaning, sterilization, corrosion resistance, stability of plate.

Traditional 510(k)

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stryker®

functionality over lifetime, transportation of the complete set and of packaging, an end product test and a design validation - end user test. The System passed all tests.

Comparison to Predicate Device

The Stryker Universal Orbital Floor System ("Subject Device") is compared to its Predicate Device for Substantial Equivalence. Side-by-side comparison tables summarizing the following criteria are provided below: .

Intended Use A:
B: Principle of Operation
Technological Characteristics ்.
D: Packaging

A: Indications for Use

Table 1: Substantial Equivalence of Indications for Use

	Subject Device	Predicate Device
	Intended Use:The Stryker Universal Orbital FloorSystem is intended to be used in thereconstruction of the floor and/ormedial wall of the orbit.	Intended Use / Indications for Use:The Synthes Craniofacial Plate and ScrewSystem is intended for use in selective traumaof the midface and craniofacial skeleton,craniofacial surgery, reconstructive proceduresand selective orthognathic surgery of themaxilla and chin.
Intended Use	Indications for Use:The Stryker Universal Orbital FloorSystem is indicated for thereconstructive treatment of orbitalfloor and/or medial wall trauma orbone excision in adult patients.	IndicationsSynthes MatrixMIDFACE Preformed OrbitalPlates are intended for trauma repair andreconstruction of the craniofacial skeleton.- Orbital floor fractures- Medial orbital wall fractures– Combined orbital floor and medial wallfractures

The intended use of the Subject Device is included in the intended use of the Predicate Device. The Predicate has the same indications for use as the Subject Device, though without age specification.

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B: Principle of Operation

Table 2: Substantial Equivalence of Principle of Operation

	Subject Device	Predicate Device
ApplicationArea	CMF/Orbital	CMF/Orbital
Operationalprinciple	Reconstruct the orbital floor and/ormedial wall	Reconstruct the orbital floor and/or medial wall
Mode offixation	Plate fixation with screws insertedthrough dedicated screw holes.	Plate fixation with screws inserted throughdedicated screw holes.
Duration ofimplantationwithin the body	Permanent implant	Permanent implant

The basic operational principle of the Subject Device, as well as the Predicate Device, is to reconstruct the orbital floor and/or medial wall. The fixation method of both the Subject Device and the Predicate is with screws inserted through dedicated screw holes. The Subject Device and the Predicate Device are both permanent implants.

C: Technological Characteristics

Table 3: Substantial Equivalence of Technological Characteristics

	Subject Device	Predicate Device
Material	Commercially Pure Titanium	Pure Titanium
Design	3D pre-bent plate based on averageanatomical model; 0.4mm thickness;Based on average anatomical model of300 CT-scans and comprising 276Caucasian subjects (92%)	3D pre-bent plate based on averageanatomical model; 0.4mm thicknessBased on average anatomical model of 279Caucasian CT-scans
Mode ofModification	Cutting / trimming along dedicatedlines; pliable mesh structure forbending	Cutting / trimming along dedicated lines;pliable mesh structure for bending
Sizes	2 sizes: large and small for left andright each	2 sizes: large and small for left and right each
Dimensions	Large Plate:L=35mm, W=36mm, H=16mmSmall Plate:L=31mm W=34mm, H=12mm	Large Plate:L=35mm, W=38mm, H=18mmSmall Plate:L=31mm, W=34mm, H=10mm
Screw Holes	· For 1.2 mm, 1.4 mm and 1.7 mmscrews· Number of screw holes along rim: 4· Two screw fixation arms with anumber of 2 screw holes each· Position of screw fixation arms at1st and 3rd screw hole from medial	· For 1.5 mm and 1.8 mm screws· Number of screw holes along rim: 4· Two screw fixation arms with a number of 2screw holes each· Position of screw fixation arms at 1st and 2ndscrew hole from medial

Traditional 510(k)

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The Subject Device is made of biocompatible commercially pure titanium (CP Ti Grade 2); the Predicate is made of pure titanium.

The Subject Device is pre-bent in a 3D shape and size similar to the Predicate Device.

D: Packaging

Table 4: Technological Characteristics of Packaging

	IN AN ANNA EN A FRIEND A BE LEAR A SECURITIE E LE PROVECE IN LE FRIENDE E LE FRUITE LE FREE LE LE LEVELIpviceIniant '	TedicateDevice
Packaging2	Non-sterile	sterile· STATIC ·

The Subject Device is delivered non-sterile. The Predicate Device is delivered nonsterile and sterile.

Substantial Equivalence Conclusion:

The Stryker Universal Orbital Floor System has similar material and technological characteristics, and the same principal of operation as the Predicate Device. The intended use and indications for use are nearly identical to the Predicate Device.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three wave-like lines representing the flow of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus, indicating the department's name and national affiliation.

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

April 9, 2013

Mr. Jamshed Badarpura Regulatory Compliance Analyst Stryker 750 Trade Center Way PORTAGE MI 49002

Re: K123786

Trade/Device Name: Stryker Universal Orbital Floor System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 4, 2013 Received: March 7, 2013

Dear Mr. Badarpura:

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. Badarpura

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 devicerelated 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.

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/6/Figure/6 description: The image shows the name "Kwame O. Ulmer" in bold, black font at the top. Below the name is a faded logo that appears to be for the FDA. To the right of the logo, the word "for" is written in a smaller, plain font.

Anthony D. Watson, B.S., M.S., M.B.A. 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):

K123786

Device Name:

Indications For Use:

Stryker Universal Orbital Floor System

The Stryker Universal Orbital Floor System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.

The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.

× 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)

Mary S. Runner -S ﺎ 2013:04.05 And DA ﺍﻟﻤﺴﺎﻋﺪﺓ 11 12:24:33 -04'00'

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

123786

Page 1 of _ 1

510(k) Number;_

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.