OsteoSymbionics Patient-Specific Cranial Implant (PEEK), manufactured by OsteoSymbionics, LLC, is a prosthetic cranioplasty implant. Each implant is sized and shaped from one or more pieces to fit the specific patient's cranial skeleton. The devices are manufactured from PEEK and provided non-sterile for sterilization prior to implantation. Implantable prosthetic cranioplasty implants are intended to fill a specific patient's defect, so each device is manufactured one at a time to custom-order based upon the patient's CT scan. The device can be crafted to include perfusion holes (2mm in diameter, spaced 10mm apart) upon surgeon preference (on order sheet). The implants are attached to the native bone with commercially available cranioplasty fasteners.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided K121102 document, organized as requested:

Acceptance Criteria and Study Information for OsteoSymbionics PEEK Patient-Specific Cranial Implant

This device is a PEEK Patient-Specific Cranial Implant, which is a physical medical device, not an AI/software device. Therefore, the questions related to AI performance, ground truth establishment, training sets, and expert adjudication are not applicable in the context of this 510(k) submission. The equivalence is established through material biocompatibility, manufacturing process validation, and mechanical testing, demonstrating comparability to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a physical implant and not an AI-driven diagnostic device, the acceptance criteria are not typically expressed in terms of sensitivity, specificity, or accuracy. Instead, they focus on material properties, manufacturing validation, and mechanical performance comparable to existing devices.

Acceptance Criteria Category	Specific Criteria (Implicitly Met for Substantial Equivalence)	Reported Device Performance (Summary)
Material Biocompatibility	PEEK material must be biocompatible for implantation.	"The PEEK materials are shown to be biocompatible..."
Manufacturing Process	Manufacturing processes must not introduce risk of contamination.	"...that manufacturing processes do not introduce risk of contamination."
Software Validation (for manufacturing)	Software facilitating manufacturing must be validated.	"The software used to facilitate the difference in manufacturing process between the original PMMA device and the PEEK device made by OsteoSymbionics has been validated."
Mechanical Performance	Mechanical properties (e.g., strength, durability) must be comparable to predicate devices.	"Mechanical testing has shown the PEEK implant to be comparable to the PMMA implant made by OsteoSymbionics."
Sterilization	Sterilization instructions must be validated.	"The sterilization instructions on the instruction for use have been validated."

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

Sample Size: Not explicitly stated in terms of patient sample size for performance evaluation. For mechanical and material testing, the "sample size" refers to the number of test specimens. This document does not specify those numbers.
Data Provenance: Not applicable in the context of clinical data provenance for an AI device. The data refers to material testing, manufacturing process validation, and software validation. Specific locations or retrospective/prospective nature are not detailed, but it would have been conducted as part of the device development and validation process by OsteoSymbionics, LLC.

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

Not applicable, as this is a physical medical implant, not an AI diagnostic device requiring expert-established ground truth from clinical cases.

4. Adjudication Method for the Test Set

Not applicable.

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

No, an MRMC study was not done. This type of study is relevant for comparing diagnostic performance of medical imaging interpretation by human readers, often with and without AI assistance. This device is a physical implant.

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

Not applicable, as this is a physical medical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is based on established engineering principles, material science standards, and performance specifications for cranioplasty implants.

Biocompatibility: Adherence to ISO standards for medical device biocompatibility.
Mechanical Performance: Comparison to the known mechanical properties of the predicate PMMA implant and other PEEK cranial implants, likely through standardized ASTM or ISO mechanical testing (e.g., strength, fatigue, impact resistance).
Manufacturing Quality: Validation of the manufacturing process to ensure consistency and sterility.
Software Validation: Confirmation that the software used in the design and manufacturing process performs as intended.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary

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K121102 :

8 2012

page 1 of 3

510(K) SUMMARY

Submitted on behalf of:

Company Name:Address:	OsteoSymbionics, LLC.1768 East 28th StreetCleveland, OH 44114
Telephone:Fax:	216-881-8500216-391-7004
by:	Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082
Telephone:Fax:	715-549-6035715-549-5380
CONTACT PERSON:	Elaine Duncan
DATE PREPARED:	July 3, 2012
TRADE NAME:	OsteoSymbionics PEEK Patient-SpecificCranial Implant
COMMON NAME:CLASSIFICATION NAME:PRO CODE:	Cranial PlatePlate, Cranioplasty, Preformed, Non-AlterableGXN

SUBSTANTIALLY EQUIVALENT TO:

The OsteoSymbionics PEEK Patient Specific Cranial Implants are substantially equivalent to: 1) OsteoSymbionics Patient Specific Cranial Implants made from PMMA (K#072601) and 2) Synthes (USA) Patient Specific Cranial/Craniofacial Implants made from PEEK (K#053199 and K#033868).

DeviceCharacteristics	OsteoSymbionicsPMMA	SynthesPEEK	OsteoSymbionicsPEEK
ClassificationRegulation	21 CFR § 882.5330	21 CFR § 882.5330	SAME
ClassificationName (ProductCode)	Preformed Non-alterableCranioplasty Plate(GXN)	Synthes (USA)Patient SpecificCranial/CraniofacialImplants (fromPEEK) (GXN)	SAME

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K121102

age 2 of 3

510(k) Summary-Continued

DeviceCharacteristics	OsteoSymbionicsPMMA	SynthesPEEK	OsteoSymbionicsPEEK
DeviceDescription	Individually sizedand shapedimplantableprostheticcranioplasty plates	Individually sizedand shapedimplantableprostheticcranioplasty plates	SAME
Intended Use	To correct defectsin craniofacialbone.	To replace bonyvoids in thecranial/craniofacialskeleton.	SAME
Design	Patient specific	Patient specific	SAME
AttachmentMethod	Attached to nativebone withcommerciallyavailablecranioplastyfasteners.	Attached to nativebone usingstandard Synthescranial andcraniofacial platesand screws.	SAME

The significant differences between the OsteoSymbionics PEEK Patient Specific Cranial Implant to the predicate made from PMMA is of course, the material PEEK, and the manufacturing methods used to make the PEEK plates compared to the processing of PMMA. The Synthes cranial implants made from PEEK preceded The OsteoSymbionics PEEK Patient Specific Cranial Implants, as have other PEEK cranial plates (not listed herein as predicates.)

DESCRIPTION of the DEVICE:

INTENDED USE: OsteoSymbionics PEEK Patient-Specific Cranial Implants are designed individually for each patient to correct defects in cranial bone.

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510(k) Summary-Continued

INDICATIONS FOR USE:

OsteoSymbionics PEEK Patient-Specific Cranial Implants are designed individually for each patient to correct defects in cranial bone.

SUMMARY of Testing and Basis for Substantial Equivalence:

OsteoSymbionics PEEK Patient-Specific Cranial Implants are manufactured from PEEK and provided non-sterilization prior to implantation. The sterilization instructions on the instruction for use have been validated.

The PEEK materials are shown to be biocompatible and that manufacturing processes due not introduce risk of contamination.

The software used to facilitate the difference in manufacturing process between the original PMMA device and the PEEK device made by OsteoSymbionics has been validated.

Mechanical testing has shown the PEEK implant to be comparable to the PMMA implant made by OsteoSymbionics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

AUG 8 . 2012

OsteoSymbionics, LLC. c/o Ms. Elaine Duncan President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082

Re: K121102

Trade/Device Name: OsteoSymbionics PK Shield (PEEK Patient-Specific Cranial Implant) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: July 27, 2012 Received: July 30, 2012

Dear Ms. Duncan:

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 - Ms. Elaine Duncan

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexa

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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Indications for Use

510(k) Number (if known):

K121102

Device Name:

OsteoSymbionics PK Shield (PEEK Patient Specific Cranial Implant)

Indications for Use:

OsteoSymbionics PK Shield (PEEK Patient Specific Cranial Implant) is designed individually for each patient to correct defects in cranial bone.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

(Brvision Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121102

Page 1 of 1

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).