The Stryker CMF MEDPOR Customized Implant is sold as a kit of two identical implants plus one host bone model. The customized craniofacial implant is molded from porous high density polyethylenc (HDPE) to the specific dimensions indicated by the surgeon via submission of CT scans. The porous HDPE Implant is fixed into place using compatible Stryker screws.

AI/ML Overview

The provided text details a 510(k) submission for the Stryker CMF MEDPOR Customized Implant. This is a traditional 510(k) for a medical device (implant), not an AI/ML software. Therefore, the typical "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, F1-score, etc.) and studies with ground truth established by experts, MRMC studies, or standalone algorithm performance are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various non-clinical performance data.

Here's a breakdown of the requested information based on the provided text, adapted to the context of a medical implant:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance (Summary from text)
Material Equivalence	- Biocompatibility testing (ISO 10993-1, ISO 10993-5)	Demonstrated by clearance of predicate devices and in vitro cytotoxicity testing performed per ISO 10993-5.
Sterilization Efficacy	- Sterilization (ISO 11135, ISO 11137, ISO 11737)	Performed in accordance with specified ISO standards.
	- EO residuals testing (ISO 10993-7)	Performed per ISO 10993-7.
	- Pyrogenicity testing (LAL per AAMI ST72)	Performed via LAL according to AAMI ST72.
Manufacturing/Design Process Validation	- Virtual Implant Design Process (VIDP) Validation	Validation performed, mirroring original VIDP Validation (cleared under K103010).
Product Integrity/Packaging	- Packaging validations (ISO 11607, ASTM F1886, F1929, D642, F88)	Performed to ensure sterility maintained throughout shelf life.
	- Ship testing (ISO 11607, ASTM F1886, F1929, D642, F88)	Performed to ensure sterility maintained throughout shelf life.
Functional Equivalence	- Bench testing (to demonstrate equivalence to predicate devices)	Performed to demonstrate equivalence of the subject device to the predicate devices.
Safety and Effectiveness	- No new clinical testing required	It was determined that none of the modifications impact safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this type of submission. The performance data is based on bench testing of the physical implant, manufacturing process validation, and biocompatibility testing, not on clinical patient data in the way an AI/ML study would utilize it. No "test set" in the context of patient data is mentioned.

3. 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)

This is not applicable. Ground truth for an AI/ML model is established by experts reviewing data. For a medical implant, "ground truth" relates to material properties, strength, sterility, and biocompatibility, which are verified through laboratory tests and engineering validations, not expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies or expert review processes, which are not described here.

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

Not applicable. MRMC studies are specific to evaluating diagnostic devices, especially those involving human interpretation, often in conjunction with AI. This submission is for a physical implant.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is derived from:

Standards Compliance: Demonstrating adherence to established ISO and ASTM standards for biocompatibility, sterilization, packaging, and pyrogenicity.
Bench Test Results: Objective measurements of the implant's physical and mechanical properties.
Validation of Manufacturing Processes: Ensuring that the Virtual Implant Design Process (VIDP) consistently produces implants to specifications.
Predicate Device Data: Leveraging the safety and effectiveness data of previously cleared, substantially equivalent devices.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device submission.

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

Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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Traditional 510(k)

NOV

1 2012

Craniomaxiliofacial

Stryker CMF MEDPOR Customized Implant

15 Dart Roud Newnan, G.I 30265 1: 770-254-4400 www.sprcker.com

510(k) Summary

October 5, 2012 Date Prepared: Sponsor/Manufacturer: Howmedica Osteonics Corp. 15 Dart Road Newnan, GA 30265 USA Distributor: Stryker Craniomaxillofacial 750 Trade Centre Way, Suite 200 Portage, MI 49002 USA 510(k) Contact Person: Stephanie Fullard Manager, Regulatory Affairs Howmedica Osteonics Corp. 15 Dart Road Newnan, GA 30265 Phone: (770) 254-4423 Fax: (678) 423-1437 stephanie.fullard@stryker.com Proprietary Name: Stryker CMF MEDPOR Customized Implant Common Name: Porous High Density Polyethylcne (HDPE) Implant Classification Name and Reference: Prosthesis, Chin, Internal, 21 CFR $878.3550 Proposed Regulatory Class: Class II Product Codes: FWP Predicate Devices: MEDPOR Customized Surgical Implant (K083621) Stryker Patient Specific Polymer Implant (K103010) Stryker Patient Specific Polymer Implant (K111065)

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Stryker CMF MEDPOR Customized Implant

V/12/3/5

20fz

Traditional 510(k)

Device Description:

Intended Use / Indications for Use:

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

Technological Characteristics:

The subject device Stryker CMF MEDPOR Customized Implant is a modification of the previously cleared MEDPOR Customized Surgical Implant. The subject device will now be sold as a kit with two sterile implants and a host bone model like the predicate Stryker Patient Specific Polymer Implants. It was determined that none of the modifications impact safety and effectiveness.

Performance Data:

The Stryker CMF MEDPOR Customized Implant was verified and validated according to Stryker procedures for product design and development. Bench testing was performed to demonstrate equivalence of the subject device to the predicate devices. Biocompatibility testing according to ISO 10993-1 was demonstrated by clearance of the predicate devices and in vitro cytoxoxicity testing was performed per 1SO 10993-5. Sterilizations were performed in accordance with ISO 11135, 11137 and 11737; EO residuals testing per ISO 10993-7 and pyrogenicity testing via LAL according to AAMI ST72. Validation of the Virtual Implant Design Process (VIDP) which mirrors the original VIDP Validation (cleared under K103010). Packaging validations and ship testing were performed in accordance with ISO 11607, ASTM F1886, F1929, D642 and F88 to ensure that sterility is maintained throughout the product's labeled shelf life.

No new clinical testing was required.

Substantial Equivalence:

The Stryker CMF MEDPOR Customized Implant is substantially equivalent to the predicate devices identified above in terms of indications, materials, design and operational principles. The Stryker CMF MEDPOR Customized Implant has been verified and validated according to Stryker procedures for product design and development. The information presented in this submission supports substantial equivalence of the Stryker CMF MEDPOR Customized Implant to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

NOV

Howmedica Osteonics, Corporation % Ms. Stephanie Fullard Manager, Regulatory Affairs 15 Dart Road Newnan, Georgia 30265

Re: K121315

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: October 05, 2012 Received: October 09, 2012

Dear Ms. Fullard:

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

1 2012

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Page 2 - Ms. Stephanie Fullard

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S 2012.11.01 15:37:19 -04'00'

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Stryker CMF MEDPOR Customized Implant

Traditional 510(k)

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Stryker® CMF MEDPOR Customized Implant

Indications for Use:

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

Prescription Use X : (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)

(Division Director)

(Division Sign-Off) Division of Surgical, Orthopedic, and Kestorative Devices

510(k) Number K121315

Page 1 of 1

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.