Dental implants OKTAGON® are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

Device Description

The proposed implants represent a line extension of dental implants OKTAGON®, which have been previously cleared in the submissions K170287, K162073 and K143539. The proposed implants have a root-form design and are made of Titanium Grade 4 conforming to ASTM F67-13. The surface is microstructured in the endosteal section by blasting with high-grade corundum and acid-etching. Tissue Level Conical Implants have a conical shape, and the endosteal body of Bone Level Tapered Design Implants is cylindrical in the coronal region and conical in the apical region. The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion. OKTAGON® Implant System includes four variations of the prosthetic connection: Tissue Level Implants: Regular Platform (RP) and Wide Platform (WP) Bone Level Implants: Regular Connect (RC) and Narrow Connect (NC). The proposed Tissue Level Conical Implants will increase the range of lengths available for this implant variation. The proposed Bone Level Tapered Design implants will be offered in the same range of lengths as the predicate devices, but with an increased diameter. The proposed healing abutments increase the range of diameters available for Bone Level Narrow Connect implants. They are manufactured from Titanium Grade 4, and are intended to close the implant and shape the surrounding soft tissue during the healing phase. No occlusal loading is intended.

AI/ML Overview

The provided text is a 510(k) premarket notification for the OKTAGON® Implant System, which is a dental implant device. As such, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way a clinical study or AI algorithm validation would.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices. Substantial equivalence means the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.

Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance directly from this document, nor can I provide details about sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set information. These concepts are typically associated with the rigorous validation of new technologies, particularly in the context of AI or novel medical devices requiring de novo clearance or PMA.

What the document does provide regarding "performance" and "acceptance criteria" (within the context of a 510(k) for dental implants):

The "performance testing" section (page 5) and the comparison table (pages 6-7) confirm that the device meets relevant standards and is comparable to previously cleared devices. The "acceptance criteria" here are implicitly tied to meeting these standards and demonstrating equivalence.

Here's a summary of the performance testing relevant to this 510(k) submission:

1. Acceptance Criteria and Reported Device Performance (as demonstrated by equivalence to predicate devices and adherence to standards):

Acceptance Criteria (Implied by Standards and Equivalence)	Reported Device Performance and Basis for Acceptance
Sterilization: Device must be sterile and sterilization process validated.	- Validation Standard: ISO 11137-1 and 11137-2 (sterilization by irradiation), ISO 17665 and ST79 (sterilization by moist heat). - Performance: Referenced from predicate K143539, with a revalidation report in Section 14 of this submission. Proposed abutments determined not to present a new sterilization challenge; thus, no additional testing required.
Sterile Barrier System: Packaging must maintain sterility.	- Validation Standard: ISO 11607. - Performance: Referenced from predicate K143539. Packaging of subject device is the same as the reference device; thus, no additional testing required.
Biocompatibility: Materials must be safe for patient contact.	- Assessment Standard: ISO 10993-1 (biological evaluation), ISO 10993-5 (cytotoxicity testing). - Performance: Referenced from predicate K143539. Subject device uses the same materials and manufacturing methods, intended use, sterilization methods, and tissue contact as the reference device; thus, no additional testing required.
Fatigue Strength: Device must withstand mechanical forces without failure.	- Testing Standard: ISO 14801 and FDA Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. - Performance: Referenced from predicates K143539, K162073, and K170287. Based on the same design and comparative surface area analysis, the proposed implants were determined not to represent a new worst case; thus, no additional testing required.
Material Composition: Device materials must conform to established standards.	- Material Standard: Titanium Grade 4 conforming to ASTM F67-13. - Performance: The proposed implants are made of Titanium Grade 4 conforming to ASTM F67-13, identical to predicate devices.
Design/Technological Characteristics: Device design must be equivalent to predicates.	- Performance: The proposed implants are described as a line extension of previously cleared OKTAGON® implants (K170287, K162073, K143539). They share root-form design, microstructured and acid-etched titanium surface, inner cone with octagonal anti-rotation device, and comparable dimensions (increased length for some Tissue Level, increased diameter for some Bone Level Tapered). Healing abutments offer increased diameter options but maintain the same base material and purpose. The manufacturer asserts the subject device and predicate devices have "identical intended use and technological characteristics, and are made of identical materials." The changes (expanded length/diameter options) are considered within the scope of previously cleared designs, not introducing new safety or performance issues.

Regarding the other points you've asked for, based on the provided text:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- No specific sample size for a "test set" (in the context of new device validation studies like clinical trials) is mentioned. The device relies on demonstrating equivalence through non-clinical testing (material, sterilization, fatigue) and comparison to predicate devices, rather than a new clinical test set.
- Data Provenance: The referenced standards (ISO, ASTM, FDA guidance) are international and US-based. The previous predicate devices were submitted by Hager & Meisinger GmbH (Germany).
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. This document describes a 510(k) submission, which relies on engineering and material standards, and comparison to predicate devices, not on expert-established ground truth for a clinical test set in the way an AI algorithm might be validated.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical trial or AI validation protocols, which are not detailed in this 510(k) submission.
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 typically for evaluating the impact of an AI system on human diagnosticians. This device is a dental implant, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical dental implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this 510(k) approval is essentially:
  - Compliance with recognized international and national standards (e.g., ISO, ASTM).
  - Demonstration of identical technological characteristics and materials to previously cleared predicate devices.
  - Demonstration that the device does not raise new performance or safety issues.
  - This is established through documented non-clinical testing (as mentioned in point 1) and comparisons of specifications.
The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above, this is a physical medical device, not an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Hager & Meisinger GmbH Adam Tomczak Regulatory Affairs Hansemannstrasse 10 Neuss, 41468 GERMANY

Mav 10, 2018

Re: K180360

Trade/Device Name: OKTAGON® Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 6, 2018 Received: February 9, 2018

Dear Adam Tomczak:

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 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
Indications for Use
510(k) Number (if known)	K180360
Device Name	OKTAGON® Implant System
Indications for Use ( Describe )	Dental implants OKTAGON® are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
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)
	CONTINUE ON A SEPARATE PAGE IF NEEDED.
	This section applies only to requirements of the Paperwork Reduction Act of 1995.
	DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
	The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov
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FORM FDA 3881 (7/17)	Page 1 of 1PSC Publishing Services (301) 443-6740 EF

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1. Applicant

Hager & Meisinger GmbH
Hansemannstrasse 10
41468 Neuss
Germany
Contact Person:	Dr. Adam Tomczak, Regulatory Affairs
Phone:	0049 2131 2012 293
Fax:	0049 2131 2012 223
Date prepared:	9 May 2018

2. Device

Trade Name:	OKTAGON® Implant System
Common Name:	Dental Implants, Dental Implant Abutments
Classification Name:	Endosseous Dental Implants
Product Code:	DZE (primary product code), NHA
Regulation No:	872.3640
Class:	II
Panel:	Dental

3. Predicate Devices

510(k) No.	Manufacturer	Trade Name
Primary predicate device:
K170287	Hager & Meisinger GmbH	Dental Implants OKTAGON® Bone Level Tapered Design
Reference devices:
K162073	Hager & Meisinger GmbH	Dental Implants OKTAGON® Tissue Level and Bone Level
K143539	Hager & Meisinger GmbH	Dental Implant System OKTAGON® Bone Level

4. Device Description

Endosseous Dental Implants

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Tissue Level Conical Implants have a conical shape, and the endosteal body of Bone Level Tapered Design Implants is cylindrical in the coronal region and conical in the apical region.

The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion. OKTAGON® Implant System includes four variations of the prosthetic connection:

Tissue Level Implants: Regular Platform (RP) and Wide Platform (WP) ●
. Bone Level Implants: Regular Connect (RC) and Narrow Connect (NC)

Ref. No.	Description	Prostheticconnection	Diameter [mm]	Length [mm]
31147	TL Conical Implant	RP	4.1	8.0
31175	TL Conical Implant	RP	4.1	12.0
24005	BLT Implant	RC	4.8	8.0
24006	BLT Implant	RC	4.8	10.0
24007	BLT Implant	RC	4.8	12.0

This submission contains the following implants:

TL =Tissue Level, BLT = Bone Level Tapered Design

The proposed Tissue Level Conical Implants will increase the range of lengths available for this implant variation. The proposed Bone Level Tapered Design implants will be offered in the same range of lengths as the predicate devices, but with an increased diameter.

Endosseus Dental Implant Abutments

The proposed healing abutments increase the range of diameters available for Bone Level Narrow Connect implants. They are manufactured from Titanium Grade 4, and are intended to close the implant and shape the surrounding soft tissue during the healing phase. No occlusal loading is intended.

Ref. No.	Description	Prostheticconnection	Diameter [mm]	Gingiva height[mm]
22070	Healing Abutment	NC	5.5	2.0
22071	Healing Abutment	NC	5.5	3.5
22072	Healing Abutment	NC	5.5	5.0

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5. Indications for Use

6. Performance testing

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include:

Sterilization validation according to ISO 11137-1 and 11137-2 (referenced from K143539; . a revalidation report can be found in Section 14 Sterilization and Shelf Life of this submission).
. Sterilization validation according to ISO 17665 and ST79 (referenced from K143539). Based on the design, it was determined that the proposed abutments do not represent a new sterilization validation challenge. Thus, no additional testing was required.
Sterile barrier system validation according to ISO 11607 (referenced from K143539). The packaging of the subject device and the reference device K143539 is the same, thus no additional testing was required.
Biocompatibility assessment according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 (referenced from K143539). The subject device uses the same materials and manufacturing methods as the reference device K 143539. Furthermore, the intended use, the sterilization methods and the tissue contact are identical. Thus, no additional testing was required.
Fatigue testing according to ISO 14801 and FDA Special Controls Guidance Document Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments (referenced from K143539, K162073 and K170287). Based on the same design and comparative surface area analysis, it was determined that the proposed implants do not represent a new worst case. Thus, no additional testing was required.

No animal testing or human clinical trials have been conducted.

7. Basis for substantial equivalence

A comparison of the indications for use and the technological characteristics between the subject device and the predicate devices is provided in the table below:

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510(k) Number	K180360	K143539 (Primary Predicate Device)	K162073	K170287 (Primary Predicate Device)
Manufacturer	Hager & Meisinger GmbH	Hager & Meisinger GmbH	Hager & Meisinger GmbH	Hager & Meisinger GmbH
Indications for Use	Dental implants OKTAGON® are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.	The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® Bone Level abutments and prosthetic parts.Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.Abutments can be used in single tooth replacements and multiple tooth restorations. The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm.The Oktagon Bone Level System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.	The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.The parts are intended to be used with OKTAGON® respectively Bone Level abutments and prosthetic parts.The OKTAGON Implant System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.	The Dental Implants OKTAGON® Bone Level Tapered Design are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
Description	The proposed implants represent a line extension of Dental Implants OKTAGON®, which have been previously cleared in the submissions K143539, K162073 and K170287. The proposed implants have a root-form design and are made of Titanium Grade 4 conforming to ASTM F67-13. The surface is microstructured in the endosteal section by blasting with high-grade corundum and acid-	The Bone Level Implant is an addition to the currently distributed OKTAGON® dental implant system.The root-form designed implant is made of commercially pure Titanium Grade 4 conforming to ASTM Standard Specification F67. The surface is micro-structured in the endosteal section and the implant shoulder is polished. The implant surface has been blasted	The Dental Implants OKTAGON® Tissue Level and Bone Level follow a root-form design and are made of commercially pure Titanium Grade 4 conforming to ASTM-F67. The surface is microstructured in the endosteal section and the surface has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder of Dental Implants OKTAGON®	The endosteal implant body of the subject device has a conical shape in the coronal region and is cylindrical in the apical region. The apical cylindrical part of the implant is relevant for the given endosteal diameter of 4.1 mm. The implants are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is micro-structured in the
510(k) Number	K180360	K143539 (Primary Predicate Device)	K162073	K170287 (Primary Predicate Device)
	conical shape, and the endosteal body of BoneLevel Tapered Design Implants is conical in thecoronal region and cylindrical in the apicalregion. The implant shoulder is polished.The prosthetic connection is achieved with thehelp of an inner cone with an additionaloctagonal anti-rotation device. A sterile coverscrew is enclosed with the implant so that animmediate occlusion of the internal thread ispossible after successful insertion.The proposed healing abutments increase therange of diameters available for Bone LevelNarrow Connect Implants. They aremanufactured from Titanium Grade 4, and areintended to seal the implant and shape thesurrounding soft tissue during the healingphase. No occlusal loading is intended.	acid-etched.The prosthetic connection is achieved with thehelp of an inner cone with an additionaloctagonal anti-rotation device. A sterile lockingscrew is enclosed with the implant so that animmediate occlusion of the internal thread isallowed after successful insertion.The endosseous dental implants are available ina range of endosseous diameters and lengths.The abutments are available in differentversions including the corresponding screws.The abutments are made of Titanium Grade 4,Titanium Alloy or POM; the connection to theimplants is achieved by an internal octagon/nutconstruction and a metric thread.The following types of abutments will beavailable:-Cover screw-Healing abutment-Straight abutment-Alligator abutment	The prosthetic connection is achieved withthe help of an inner cone with an additionaloctagonal antirotation device. A sterile coverscrew is enclosed with the implant so that animmediate occlusion of the internal thread ispossible after successful insertion.	high-grade corundum and afterwards acid-etched. The implant shoulder is polished.The prosthetic connection is achievedwith the help of an inner cone with anadditional octagonal anti-rotation device. Asterile cover screw is enclosed with theimplant so that an immediate occlusion ofthe internal thread is possible aftersuccessful insertion.
Material	Titanium Grade 4	Implants: Titanium Grade 4Abutments: Titanium Grade 4, Ti6Al4V, POM	Titanium Grade 4	Titanium Grade 4
EndosseousSurface	Micro-structured (grit blasted and acid etched)		Micro-structured (grit blasted and acid etched)
Connection	Inner cone with octagonal anti-rotation device		Inner cone with octagonal anti-rotation device
Length	8/ 10/ 12 mm	8/ 10/ 12/ 14 mm	8/ 10/ 12 mm	8/ 10/ 12 mm
EndosseousDiameter	4.1/ 4.8 mm	3.3 /4.1/ 4.8 mm	3.75 / 4.1 mm	3.3 / 3.75/ 4.1 mm

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8. Conclusion

The subject device and the predicate devices have identical intended use and technological characteristics, and are made of identical materials. Based on the assessment of applicable performance data, the subject device does not raise new performance or safety issues. Thus, we concluded that the subject device is substantially equivalent to the legally marketed predicate devices listed above.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.