(151 days)
PEEK Customized Cranial Implant Kit is intended to be used to replace bony voids in the cranial and the craniofacial skeleton.
The PEEK Customized Cranial Implant Kit is indicated for filling bony voids in the cranial and craniofacial skeleton in patients 12 years of age and older.
PEEK Customized Implant Kit consists of the PEEK Customized Cranial Implant or the PEEK Customized Craniofacial Implant, the Host Bone Model, and the Design Proposal.
PEEK Customized Cranial Implant: The PEEK Customized Cranial Implant is a customized patient-specific implant based on CT-data and input by the surgeon. The implant is fabricated from polyetheretherketone (PEEK) and is intended to be used to fill bony voids in the cranial skeleton. It is delivered non-sterile.
PEEK Customized Craniofacial Implant: The PEEK Customized Craniofacial Implant is a customized patient-specific implant based on CT-data. The implant is fabricated from polyetheretherketone (PEEK) and is intended to be used to fill bony voids in the craniofacial region (orbital rim, zygoma, and adjacent bone). The implant matches the shape and dimensions of the missing bone fragments. It is delivered non-sterile.
The host bone model is provided as a preoperative guide to demonstrate orientation and fit of the Peek Customized Cranial Implant. The Design Proposal is a presentation of virtual 3-dimensional models of the implant design. The PEEK Customized Cranial Implant is offered in different sizes based on the size of the cranial defect. Depending on the surgeon's preference, the PEEK Customized Cranial Implant may be constructed in varying thicknesses, wall designs, number of dura suture holes and dura suture hole diameters. The PEEK Customized Cranial Implant is fixated to the native bone with Stryker Neuro, Midface or Upperface self-tapping screws. The PEEK Customized Cranial and Craniofacial Implant Kit is bundled with an online ordering system called "eRequest Lifecycle", whereby the user can initiate a case request, upload the patient specific image data, download the Design Proposal and approve the implant design.
This document describes the PEEK Customized Cranial Implant Kit, a custom patient-specific implant intended to replace bony voids in the cranial and craniofacial skeleton. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving independent performance against specific acceptance criteria. Therefore, several requested details about acceptance criteria, study design, and ground truth are not explicitly provided in the document as it's a 510(k) submission for a medical device, not an AI/ML algorithm.
However, based on the provided text, the following information can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission for a physical medical implant, the "acceptance criteria" are primarily related to mechanical properties, material compatibility, and fit, rather than performance metrics like sensitivity or specificity typically seen in AI/ML performance studies. The "reported device performance" refers to the results of various physical tests.
| Acceptance Criteria (Inferred from tests performed) | Reported Device Performance |
|---|---|
| Mechanical Strength: Comparable to native skull. | Demonstrated mechanical strength comparable to native skull. |
| Integrity during surgical manipulation: Not melt or lose integrity upon burring, drilling, and/or screw insertion with recommended tools. | Did not melt or lose integrity upon burring, drilling, and/or screw insertion. |
| Fit and User Needs: Implants meet user needs and fit defects. | Met user needs and fit the defects (handling test in Cadaver Lab with surgeons). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions a "Cadaver Lab" for handling tests and various "performance tests" (stability, trimming, drilling, screw insertion, screw pull-out). However, the specific sample sizes for these tests are not provided. Similarly, the data provenance (e.g., country of origin, retrospective or prospective) for these physical tests is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
For the "handling test performed in a Cadaver Lab," it states that "surgeons demonstrated that the implants met the user needs and fit the defects."
- Number of experts: Not explicitly stated, but implies multiple surgeons were involved.
- Qualifications of experts: Identified as "surgeons." No further specific qualifications (e.g., years of experience, subspecialty) are provided.
4. Adjudication Method for the Test Set:
Given the nature of the tests, a formalized adjudication method like 2+1 or 3+1 is not applicable. The "handling test" involved surgeons demonstrating fit and meeting user needs, implying a qualitative assessment of suitability. The mechanical tests would have objective pass/fail criteria based on quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices or AI algorithms where human reader performance is a key metric. This submission is for a physical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, in the context of the device's design process. The document describes a "Virtual Implant Design Process (VIDP)" using CT-data to generate a 3D model and design the implant. This design process, which is an algorithm-driven component, is described as "validated." The performance data for the physical implant itself (mechanical strength, integrity) would be considered "standalone" as it's testing the final product independent of the human intervention during design approval.
7. The Type of Ground Truth Used:
- For mechanical tests (stability, trimming, drilling, screw insertion, screw pull-out): The ground truth would be based on engineering specifications and established mechanical properties of native bone (implicitly, as the device aims for "comparable to native skull" strength).
- For the handling test in the Cadaver Lab: The ground truth was based on expert consensus/qualitative assessment from surgeons regarding fit and user needs.
8. The Sample Size for the Training Set:
This question primarily applies to AI/ML algorithms that learn from data. While the device design uses patient CT data, the document does not describe it as a "training set" in the machine learning sense. The "Virtual Implant Design Process (VIDP)" is described as "validated," implying that the rules, algorithms, and processes for custom implant design were developed and verified, but it doesn't refer to a statistical "training set" of patient cases for an AI model to learn from.
9. How the Ground Truth for the Training Set Was Established:
Again, this question is not directly applicable in the AI/ML sense to this 510(k) submission. The "ground truth" for the "Virtual Implant Design Process" would refer to the accuracy and validity of the 3D modeling and design algorithms in replicating the desired anatomical structures and ensuring proper fit based on CT data. This would be established through engineering validation, potentially against known anatomical models or validated software outputs, during the development of the VIDP itself. The document states a "validated 'Virtual Implant Design Process' (VIDP)" is used, but doesn't elaborate on the validation specifics.
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K121153 page / of 4
PEEK Customized Cranial Implant Kit
750 Trade Centre Way Suite 200 Portage, MI 49002 t: 269 324 5346 f: 877 648 7114 www.strvker.com
Traditional 510(k)
tryker®
SEP 14 2012
Craniomaxillofacial
Stryker Leibinger GmbH & Co. KG
510(k) Summary
Sponsor:
Proprietary Name:
Common Name:
Classification Name and Reference:
Proposed Regulatory Class:
Product Codes:
Predicate Devices:
Contact Person:
Date Prepared:
PEEK Customized Cranial Implant Kit
Customized Cranial Implant
Boetzinger Strasse 41 79111 Freiburg, Germany
21 CFR §882.5320 - Preformed alterable cranioplasty plate
Class II
GWO
K053199 - Synthes Patient Specific Cranial/Craniofacial Implant
K111065 - Stryker Patient Specific Polymer Implant
Manish Patel Regulatory Compliance Analyst Stryker Craniomaxillofacial 750 Trade Centre Way, Suite 200 Portage, MI 49002 Phone: (269) 389-4271 Fax: 877-648-7114 manish.patel@stryker.com
April 12, 2012
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Traditional 510(k)
Intended Use:
PEEK Customized Cranial Implant Kit is intended to replace bony voids in the cranial and the craniofacial skeleton.
Indications for Use:
The PEEK Customized Cranial Implant Kit is indicated for filling bony voids in the cranial and craniofacial skeleton in patients 12 years of age and older.
Device Description:
PEEK Customized Implant Kit consists of the PEEK Customized Cranial Implant or the PEEK Customized Craniofacial Implant, the Host Bone Model, and the Design Proposal.
PEEK Customized Cranial Implant:
The PEEK Customized Cranial Implant is a customized patient-specific implant based on CT-data and input by the surgeon. The implant is fabricated from polyetheretherketone (PEEK) and is intended to be used to fill bony voids in the cranial skeleton. It is delivered non-sterile.
PEEK Customized Craniofacial Implant:
The PEEK Customized Craniofacial Implant is a customized patient-specific implant based on CT-data. The implant is fabricated from polyetheretherketone (PEEK) and is intended to be used to fill bony voids in the craniofacial region (orbital rim, zygoma, and adjacent bone). The implant matches the shape and dimensions of the missing bone fragments. It is delivered non-sterile.
The host bone model is provided as a preoperative guide to demonstrate orientation and fit of the Peek Customized Cranial Implant. The Design Proposal is a presentation of virtual 3-dimensional models of the implant design. The PEEK Customized Cranial Implant is offered in different sizes based on the size of the cranial defect. Depending on the surgeon's preference, the PEEK Customized Cranial Implant may be constructed in varying thicknesses, wall designs, number of dura suture holes and dura suture hole diameters. The PEEK Customized Cranial Implant is fixated to the native bone with
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Traditional 510(k)
Stryker Neuro, Midface or Upperface self-tapping screws. The PEEK Customized Cranial and Craniofacial Implant Kit is bundled with an online ordering system called "eRequest Lifecycle", whereby the user can initiate a case request, upload the patient specific image data, download the Design Proposal and approve the implant design.
Technological Characteristics:
The PEEK Customized Cranial and Craniofacial Implant Kit is designed individually on a patient-by- patient basis upon request of the surgeon using a validated "Virtual Implant Design Process" (VIDP). A CT scan received from the health care facility is used to generate a 3 dimensional model of the skull with the defect to be filled. This 3dimensional model of the skull is then used to design the implant. The design is virtually presented as a Design Proposal, which is then reviewed and approved remotely by the surgeon, and modified if desired. Once the design is approved, the PEEK Customized Cranial and Craniofacial Implant Kit and the Host Bone Model are manufactured and shipped to the health care facility along with a print of the approved Design Proposal. The PEEK Customized Cranial and Craniofacial Implant Kit are offered non-sterile to the customer.
The PEEK Customized Cranial and Craniofacial Implant Kit are similar or identical to its predicate devices in the following technical characteristics:
- · Material: The PEEK Customized Cranial Implant and the Synthes Patient Specific Cranial/Craniofacial Implant - K053199 are made of the identical medical grade PEEK Optima LT1 from the same supplier, Invibio
- Design: The PEEK Customized Cranial Implant and the Stryker Patient Specific Polymer Implant - K111065 are designed using the identical software and Virtual Implant Design Process (VIDP)
- The PEEK Customized Cranial Implant and the Synthes Patient · Sterility: · Specific Cranial/Craniofacial Implant – K053199 are delivered non-sterile to the user
- Case initiation and data exchange: The PEEK Customized Cranial Implant and the Stryker Patient Specific Polymer Implant – K111065 use identical systems
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for case initiation, uploading of imaging data, downloading of Design Proposal and approval.
Performance Data:
Various performance tests including stability tests, trimming tests, drilling tests, screw insertion tests and screw pull-out tests were performed on the PEEK Customized Cranial Implants and Craniofacial Implants. The results of these tests demonstrated that the PEEK Customized Cranial and craniofacial Implants have mechanical strength comparable to native skull, and do not melt or lose integrity upon burring, drilling and/or screw insertion with recommended burrs, drills and screws. A handling test performed in a Cadaver Lab with surgeons demonstrated that the implants met the user needs and fit the defects.
Substantial Equivalence:
The PEEK Customized Cranial and Craniofacial Implant Kit are substantially equivalent to its predicate devices in regards to intended use, design, materials and operational principle. Further, the performance data confirms that the PEEK Customized Cranial and Craniofacial Implant Kit are safe and effective and performs as well as its predicate devices listed below.
Predicate Devices:
-
- Synthes Patient Specific Cranial/Craniofacial Implant K053199.
-
- Stryker Patient Specific Polymer Implant K111065.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 14 2012
Stryker Craniomaxillofacial c/o Mr. Manish Patel Regulatory Compliance Analyst 750 Trade Centre Way, Suite 200 Portage, MI 49002
Re: K121153
Trade/Device Name: PEEK Customized Cranial Implant Kit Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO Dated: September 5, 2012 Received: September 6, 2012
Dear Mr. Patel:
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. Manish Patel
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/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PEEK Customized Cranial Implant Kit
Traditional 510(k)
Indications for Use:
510(k) Number (if known): K12 | 153
Device Name: PEEK Customized Cranial Implant Kit
Intended Use:
PEEK Customized Cranial Implant Kit is intended to be used to replace bony voids in the cranial and the craniofacial skeleton.
Indications for Use:
The PEEK Customized Cranial Implant Kit is indicated for filling bony voids in the cranial and craniofacial skeleton in patients 12 years of age and older.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).