The MEDPOR TITAN® 3D Orbital Floor Implant is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older.

Device Description

The MEDPOR TITAN® 3D Orbital Floor Implants are comprised of a pre-bent titanium mesh embedded within a MEDPOR porous polyethylene sheet. The porous side allows tissue ingrowth while a nonporous Barrier sheet on the orbit facing side does not allow tissue ingrowth. The pre-bent shape approximates the shape and dimensions of the average normal orbital floor and medial wall (in order to facilitate the operative goal of restoring normal [pre-traumatic] orbital volume as accurately as possible). The pre-bent MEDPOR titanium plates are available in a small (L=32mm W=35mm, H=13mm) and a large size (L=36mm, W=37mm, H=17mm) along with left and right configurations. The implants can be trimmed and contoured to fit the specific needs of the patient.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Stryker MEDPOR TITAN 3D Orbital Floor Implant. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided text, there is no study detailing acceptance criteria and reported device performance in the context of AI/ML or diagnostic accuracy. The document focuses on regulatory approval for a physical implant, not a diagnostic or prognostic algorithm.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML study is not applicable to this document.

However, I can extract the information related to the device itself and its testing:

Summary of Device Acceptance Criteria and Performance (Based on provided text)

Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	In accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1; including cytotoxicity testing (DIN EN 10993-5:2009).	Cytotoxicity testing was performed using DIN EN 10993-5:2009. The tests supported the biocompatibility of the device. The device materials (titanium conforming to ASTM F67, MEDPOR porous polyethylene, nonporous barrier) are the same as predicate devices and use the same manufacturing processes.
Performance Bench Testing	Pre-defined acceptance criteria for: - Transportation testing - End user testing - Packaging assessment - Bending assessment - Trimming assessment - Stability test (globe support) - Sharp edge test	The Subject device met all pre-defined acceptance criteria. In tests where it was compared to either the predicate or reference device, it was found to "not represent a new worst case." The results support substantial equivalence.
Principle of Operation	To reconstruct the orbital floor and/or medial wall; same mode of fixation (screws); same patient contacting surface (orbital floor and wall); same area/duration of contact; similar material and design to predicate.	The device operates on the same principle as the predicate, with the same mode of fixation, patient contacting surface, area/duration of contact. Material is similar (titanium in predicate, titanium mesh embedded in polyethylene in subject device). Design is similar (pre-bent shape based on average anatomical model), comparable sizes and shapes to predicate device. The subject device is provided sterile, similar to reference device.

Regarding the specific questions:

A table of acceptance criteria and the reported device performance
- See table above.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No "test set" in the context of an AI/ML diagnostic test is mentioned. The device's design was based on an average anatomical model derived from CT-scan data from 300 subjects.
- Data Provenance (for anatomical model): Not explicitly stated, but the "Ethnic Group" breakdown includes Caucasians (276), Middle-East (3), and unknown (21), suggesting a varied origin, though predominantly Caucasian data were used for the anatomical model. The manufacturer is based in Germany.
- Retrospective/Prospective: The CT-scan data for the anatomical model was likely retrospective, as it was "selected scans... obtained from healthy subjects."
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)
- Not applicable. There is no mention of a "ground truth" established by experts for a diagnostic test. The "ground truth" for the device's design implicitly comes from clinical understanding of normal orbital anatomy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the device's design: The "ground truth" for the anatomical model was derived from CT-scan data from 300 healthy subjects without bony orbital deformations. This could be considered a form of "anatomical truth" or "normative data." Clinical outcomes are mentioned only in the context of a literature review supporting general safety, not for establishing ground truth for a test.
The sample size for the training set
- Not applicable in the AI/ML sense. The anatomical model used for the device design was based on 300 CT scans. This could be considered analogous to a "training set" for the device's shape design.
How the ground truth for the training set was established
- The anatomical model was established by analyzing CT-scan data from 300 subjects. These were "selected scans... obtained from healthy subjects without any deformation of the bony orbital structures." This implies that the selection process itself established the "ground truth" for what constitutes a normal orbital floor and medial wall.

Summary

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

May 5, 2015

Stryker Ms. Julie Schoell M.S., RAC Staff Regulatory Affairs Specialist 750 Trade Centre Way - Suite 200 Portage, Michigan 49009

Re: K142568

Trade/Device Name: Stryker MEDPOR TITAN 3D Orbital Floor Implant Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: April 10, 2015 Received: April 13, 2015

Dear Ms. Schoell:

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 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 Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

Tina
Kiang-S

for Erin I. Keith, M.S. 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) K142568

Device Name Stryker MEDPOR TITAN® 3D Orbital Floor Implant

Indications for Use (Describe)

The MEDPOR TITAN® 3D Orbital Floor Implant is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 5. 510(k) Summary – K142568

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

l. SUBMITTER

510(k) Owner:	Stryker Leibinger GmbH& Co. KGBoetzinger Strasse 41D-79111 Freiburg, Germany
Submitter/Contact Person:	Julie Schoell, M.S., RACStaff Regulatory Affairs SpecialistStryker Craniomaxillofacial750 Trade Centre WayPortage, MI 49002Phone: 269-389-3419Fax: 877-648-7114
RegistrationNumber:	8010177
Date prepared:	April 29, 2015
II. DEVICE
Trade Name:	Stryker MEDPOR TITAN® 3D Orbital Floor Implant
Common or Usualname:	Plate, Bone
Classificationname:	Bone Plate (21 CFR 872.4760)
Regulatory Class:	Class II
Product Code:	JEY

III. PREDICATE DEVICE

Predicate Device: Stryker Universal Orbital Floor System - K133461

Reference Device: MEDPOR Craniofacial Implants with Embedded Titanium Mesh – K040364

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IV. DEVICE DESCRIPTION

The implants 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.

Age [years]		Gender		Ethnic
10-19	18	f	122	ca	276
20-29	19	m	178	me	3
30-39	20			xx	21
40-49	28
50-59	36
60-69	56
70-79	72
80-89	44
90-99	6

TABLE 1: META DATA OF THE 300 CT SCANS

Age: 297 scans: age 15-95, 1 scan: age 14, 1 scan: unknown; average age: 59 years:

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

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

The associated accessories include the following previously cleared devices:

Adjustable-width globe retractor -
Plate holding forceps -
-Stryker screws and accessories

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The Subject device will be provided sterile, and is intended for single use only. The plate holding forceps and adjustable-width globe retractor are provided non-sterile and are reusable.

INDICATIONS FOR USE V.

The MEDPOR TITAN® 3D Orbital Floor Implant is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older.

	Subject Device	Predicate Device -K133461	Reference Device -K040364
Indicationsfor Use	The MEDPORTITAN® 3D OrbitalFloor Implant isindicated for thereconstructivetreatment of orbitalfloor and/or medialwall trauma or boneexcision in patients15 years of age andolder.	The Stryker UniversalOrbital Floor Systemis indicated for thereconstructivetreatment of orbitalfloor and/or medialwall trauma or boneexcision in patients 15years of age andolder.	MEDPOR Biomaterialwith EmbeddedTitanium MeshImplants are intendedfor non-weight bearingapplications ofcraniofacialreconstruction/cosmeticsurgery and repair ofcraniofacial trauma.

TABLE 2: COMPARISON OF INDICATIONS FOR USE

The Indications for Use statement for the MEDPOR TITAN 3D Orbital Floor Implant is identical to the predicate device Stryker Universal Orbital Floor System.

The Indications for Use statement for the MEDPOR TITAN 3D Orbital Floor Implant is not identical to the reference device MEDPOR Craniofacial Implants with Embedded Titanium Mesh Implants; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. The MEDPOR Craniofacial Implants with Embedded Titanium Mesh are indicated for a use in a range of anatomic areas for a variety of surgical applications. The Indications for use of the MEDPOR TITAN 3D Orbital Floor Implant falls within the scope of the broader Indications for Use statement of the reference device. The difference in the Indications statement for the proposed device in comparison to the reference device does not constitute a new intended use. Both the subject and predicate device have

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the same intended use for the reconstruction of the floor and/or medial wall of the orbit.

A review of the literature was performed to identify relevant clinical literature to represent applicable data on the performance of the Stryker MEDPOR TITAN 3D Orbital Floor Implant in the use of the orbital floor. Results of the data demonstrates the absences of unreasonable risk of illness or injury associated with use of the Stryker MEDPOR TITAN 3D Orbital Floor Implant for its intended uses and conditions of use; in this case, in a pediatric sub-population 15 to 21 years of age and for reconstruction of the craniofacial skeleton, of which the orbital floor and/or wall is indicated.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The MEDPOR TITAN 3D Orbital Floor Implant is compared to its predicate devices for substantial equivalence based on the following criteria:
A. Principle of Operation
B. Technological Characteristics

A. Principle of Operation

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 device is with screws inserted through dedicated screw holes. Both the Subject device as well as the Predicate device can be trimmed and contoured to fit the specific needs of the patient. The Subject device and the Predicate device are permanent implants and have the same craniofacial/orbital area of application.

B. Technological and Operational Characteristics

At a high level, the Subject device and Predicate device are based on the following technological elements:

-Same operating principle: reconstruct the orbital floor and/or medial wall
Same mode of fixation: plate fixation with screws inserted through dedicated screw holes
-Same patient contacting surface: orbital floor and wall
Same area of contact and contact duration (tissue/bone/greater than 30 days)

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Similar material: while the MEDPOR Craniofacial Implants with Embedded Titanium Mesh reference device has the same material, the Stryker Universal Orbital Floor System is provided only in titanium.
Similar design: while the Stryker Universal Orbital Floor System has a pre-bent shape based on the same average anatomical model, the MEDPOR Craniofacial Implants with Embedded Titanium Mesh are provided in a 2D, non-bent shape.
-Similar sizes and shapes compared to the Predicate device
The MEDPOR TITAN 3D Orbital Floor Implant is provided sterile. While the MEDPOR Craniofacial Implants with Embedded Titanium Mesh reference device is provided sterile, the Stryker Universal Orbital Floor System is provided non-sterile.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the MEDPOR TITAN 3D Orbital Floor was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing included cytotoxicity testing.

The cytotoxicity testing was performed using DIN EN 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. The tests supported the biocompatibility of the device.

The MEDPOR TITAN 3D Orbital Floor Implant is considered a permanent implant, tissue contacting greater than 30 days. The implant is made from a combination of titanium mesh embedded within a MEDPOR porous polyethylene sheet with a nonporous Barrier on one side, the same as the Predicate devices. The titanium conforms to ASTM F67 for chemical composition. The same manufacturing processes and identical materials are used in the predicate devices and the Subject device.

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Performance Bench Testing

The following performance bench tests were completed.

Transportation testing -
End user testing -
Packaging assessment -
Bending assessment -
Trimming assessment -
Stability test (globe support) -
-Sharp edge test

The Subject device met all pre-defined acceptance criteria and, in tests where it was compared to either the predicate or reference device, was found to not represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device.

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.

VIII. CONCLUSIONS

The results of the non-clinical data demonstrate the MEDPOR TITAN 3D Orbital Floor Implants 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.

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.