The Stryker CMF MEDPOR® Customized Implant is sold as a kit of two identical implants plus one host bone model. The Stryker CMF MEDPOR Customized Implants are molded from porous high density polyethylene (HDPE) to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request. The porous structure of the MEDPOR material allows for tissue ingrowth. The implant is fixed into place using compatible Stryker fixation systems. The implants and host bone model are provided sterile for single use only.

AI/ML Overview

This document describes a 510(k) premarket notification for the Stryker CMF MEDPOR® Customized Implant. The submission focuses on adding two additional surgeon design options to an already cleared predicate device (K121315). As such, the information provided primarily addresses the differences and similarities to the predicate device rather than a comprehensive, standalone performance study for the original device.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative numerical format typically found in performance studies for new algorithms or devices with new functionalities. Instead, the "acceptance" for this 510(k) hinges on demonstrating substantial equivalence to the predicate device.

The performance data supplied is for the modifications to the device and demonstrates that the modifications do not negatively impact the device's equivalence to the predicate.

Performance Data Category	Description	Reported Device Performance / Assessment
Biocompatibility	Assessment of biological compatibility of materials.	Not required; no change in material, duration/location of contact, or sterilization method from predicate.
Performance Bench Testing
- Screw Pullout Testing	Testing the strength of screw fixation in the modified implant.	Completed (implied successful as no issues raised for substantial equivalence).
- End user validation testing	Validation by end-users (surgeons) for the modified design options.	Completed (implied successful as no issues raised for substantial equivalence).
Software Verification and Validation	Verification and validation of software used in the design process.	Software is used in the design process, but the addition of design options doesn't change manufacturing process, and internal control systems remain unchanged from predicate (K121315). Therefore, the existing software validation from the predicate is deemed sufficient.
Animal Testing	Testing conducted on animal models.	Not required; no change in material, duration/location of contact, or sterilization method from predicate.
Clinical Testing	Human clinical trials.	Not required; no change in intended use/indications for use or fundamental technological characteristics.

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

This document does not describe a "test set" in the context of typical AI algorithm validation (e.g., a dataset of images with ground truth). The performance data cited are primarily bench tests and software/material assessments against the predicate device.

Screw Pullout Testing: The specific sample size for this test is not mentioned.
End User Validation Testing: The number of end-users or cases involved is not specified.
Data Provenance: Not applicable in the context of this 510(k) where clinical dataset provenance is not the focus. The documentation comes from Stryker Leibinger (Germany and USA).

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

Not applicable. This 510(k) is not for an AI algorithm that requires expert-established ground truth on a test set. The validation revolves around maintaining safety and effectiveness equivalent to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication of ground truth is described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a customized implant, not an AI diagnostic algorithm, so such a study would not be relevant.

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

Not applicable. This device is a physical customized implant, not an AI algorithm, and therefore does not have a "standalone" or "human-in-the-loop" performance in the sense of AI. While software is used in its design process, the 510(k) states that the addition of design options does not change the manufacturing process or internal control systems, implying that the existing software validation (from the predicate K121315) is sufficient, and no new standalone software performance study was required.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI algorithms (e.g., pathology, expert consensus) is not directly applicable here. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device (K121315). The aim of the submission is to demonstrate that the proposed modifications do not alter this established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This 510(k) is not for an AI algorithm developed using a training set.

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

Not applicable. This 510(k) is not for an AI algorithm.

Summary

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

March 23, 2015

Stryker Leibinger Ms. Julie Schoell Staff Regulatory Affairs Specialist 750 Trade Centre Way, Suite 200 Portage, Michigan 49002

Re: K143173

Trade/Device Name: Stryker CMF MEDPOR® Customized Implant Regulation Number: 21 CFR 878.3550 Regulation Name: Chin prosthesis Regulatory Class: Class II Product Code: FWP Dated: February 17, 2015 Received: February 18, 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.

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

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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 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" (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 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.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K143173

Device Name Stryker CMF MEDPOR® Customized Implant

Indications for Use (Describe)

The Stryker CMF MEDPOR® Customized Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

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

2 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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510(k) SUMMARY (Per 21 CFR 807.92)

I. SUBMITTER

510(k) Owner:	Stryker LeibingerGmbH& Co. KGBoetzinger Strasse 41D-79111 Freiburg, Germany
Submitter/ ContactPerson:	Julie SchoellStaff Regulatory Affairs SpecialistStryker Craniomaxillofacial750 Trade Centre WayPortage, MI 49002Phone: 269-389-3419Fax: 877-648-7114

Date prepared: November 3, 2014

II. DEVICE

510(k) Number:	K143173
Trade Name:	Stryker CMF MEDPOR® Customized Implant
Common name:	Prosthesis, chin, internal
	Classification name: Chin prosthesis (21 CFR 878.3550)
Regulatory Class:	Class II
Product Code:	FWP

III. PREDICATE DEVICE

Stryker CMF MEDPOR Customized Implant – K121315 This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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Proposed Modification: The Subject device Stryker CMF MEDPOR Customized Implant has the same Intended Use/Indications for use, material, and operational principle as the Primary predicate Stryker CMF MEDPOR Customized Implant K121315. This 510(k) is being submitted to allow for two additional surgeon design options.

V. INDICATIONS FOR USE

The Stryker CMF MEDPOR Customized Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

The proposed modifications do not alter the Intended Use/Indications for Use statement for the Subject device. The Intended Use/Indications for Use is identical to the Primary predicate device Stryker CMF MEDPOR Customized Implant K121315.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The Stryker CMF MEDPOR Customized Implant is compared to its predicate device 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 Stryker CMF MEDPOR Customized implant remains the same: to augment or restore bony contours in the craniofacial region. The Subject device allows for fixation with previously cleared Stryker screws with the addition of plates from the same previously cleared Stryker product line. Both the Subject device and 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 area of application.

B. Technological and Operational Characteristics

The Subject device and Predicate devices are based on the following technological elements:

Same operating principle: to augment or restore bony contours in the craniofacial region
Same area of contact and contact duration (tissue/bone/greater than 30 days) -
-Same sizes as the Primary predicate device
-Same material: there is no change in the implant or host bone material
Same sterilization method: there is no change in the implant or host bone sterilization method

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Similar design process: the proposed modification allows for additional design options compared to the Primary predicate. The surgeon may now choose a nonflanged inlay implant and provide additional "single stage" design inputs for the scope of the implant reconstruction boundary.
-Similar mode of fixation: screw fixation with the addition of plate fixation

VII. PERFORMANCE DATA

Based on the Risk Analysis performed on the modifications to the device, the following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

Biocompatibility testing was not required as a basis for substantial equivalence. There is no change in the material, duration or location of contact or sterilization method.

Performance Bench Testing

The following performance bench tests were completed.

-Screw Pullout Testing
End user validation testing -

Software Verification and Validation Testing

The Stryker CMF MEDPOR Customized Implant does not directly contain software or have an electronic user interface.

Software is used in the design process of the Stryker CMF MEDPOR Customized Implant. The addition of the single stage design option does not change the manufacturing process. The same internal control systems as cleared in the predicate K121315 remain unchanged.

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 Stryker CMF MEDPOR Customized Implant 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

§ 878.3550 Chin prosthesis.

(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.