The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. It is intended for delayed loading.

The MS SA Implant (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The MS SA Implant (Narrow Ridge) is intended for single use only. It is intended for delayed loading.

Device Description

The MS SA Implant System is a dental implant made of titanium alloy (Ti-6Al-4V) metal. The MS SA Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface treatment of MS SA Implant System is SA (Sandblasting and Acid etching).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "MS SA Implant System," a dental implant device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical efficacy through new clinical trials against acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, specific study designs (like MRMC), and detailed performance metrics derived from such studies is not available in this document.

Here's what can be extracted and inferred from the text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is assessed by comparing the device's characteristics to those of the predicate devices. The table below summarizes the comparison presented in the document.

Feature	MS SA Implant System (Narrow Ridge)	MS System (Narrow Ridge) (Predicate)	Straumann Dental Implants (Predicate) (for surface)
Intended Use	Treatment of missing mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, to restore chewing function in partially edentulous patients. Single use only. Delayed loading.	Treatment of missing mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, to restore chewing function in partially edentulous patients. Single use only.	Immediate placement and function for single and/or multiple tooth applications with good primary stability and appropriate occlusal loading to restore chewing function. Multiple tooth applications may be rigidly splinted. For edentulous patients, four or more implants must be used. Supports prosthetic restorations in edentulous or partially edentulous patients. Maxillary and/or mandibular arches.
Structure	SA(Sandblasting and Acid etching). Threaded Body Design. One Body Implant.	R.B.M (Resorbable Blasting Media). Micro Thread Design. Threaded Body Design. One Body Implant.	Single Thread. Straight body Type. Non-submerged fixture.
Thread Body Dia	2.5, 2.9 (mm)	2.5, 3.0 (mm)	3.3~4.8 (mm)
Length of Thread	8.5, 10.0, 11.5, 13.0 (mm)	8.5, 10.0, 11.5, 13.0, 15.0 (mm)	6.0~16.0 (mm)
Material	Titanium alloy Ti-6Al-4V (ASTM F 136)	Titanium alloy Ti-6Al-4V (ASTM F 136)	Pure Titanium Grade 4 (ASTM F67)
Surface	SA (Sandblasting and Acid etching)	R.B.M (Resorbable Blasting Media)	SLA (Grit blasting, acid etched SLA surface)
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
Substantial Equivalence Statement	Same material, indication for use, and similar design as MS System (K083067), except for surface treatment. Surface treatment is similar to Straumann Dental Implants (K061176).	(Reference for comparison)	(Reference for comparison)

Feature	MS SA Implant System (Denture)	MS System (Denture) (Predicate)	Straumann Dental Implants (Predicate) (for surface)
Intended Use	Placed in the bone of the upper or lower jaw arches to provide support of prosthetic devices to restore chewing function, including denture stabilization. Single use only.	Placed in the bone of the upper or lower jaw arches to provide support of prosthetic devices to restore chewing function, including denture stabilization. Single use only.	Immediate placement and function for single and/or multiple tooth applications with good primary stability and appropriate occlusal loading to restore chewing function. Multiple tooth applications may be rigidly splinted. For edentulous patients, four or more implants must be used. Supports prosthetic restorations in edentulous or partially edentulous patients. Maxillary and/or mandibular arches. Narrow Neck implants indicated for replacement of single lateral incisors in maxilla and lateral/central incisors in mandibles, for limited interdental and vestibule-oral bone space. Can support full arch implant-born restoration with a standard Straumann 4.1 mm dental implant.
Structure	SA(Sandblasting and Acid etching). Ball-shaped suits for O-Ring attachment. 2/4mm can be used according to gingival height. Threaded Body Design.	R.B.M (Resorbable Blasting Media). Ball-shaped suits for O-Ring attachment. 2/4mm can be used according to gingival height. Micro Thread Design. Threaded Body Design.	Single Thread. Straight body Type. Non-submerged fixture.
Thread Body Dia	2.5, 2.9 (mm)	2.0, 2.5, 3.0 (mm)	3.3~4.8 (mm)
Length of Thread	8.5, 10.0, 11.5, 13.0 (mm)	8.5, 11.5 (mm)	6.0~16.0 (mm)
Material	Titanium alloy Ti-6Al-4V (ASTM F 136)	Titanium alloy Ti-6Al-4V (ASTM F 136)	Pure Titanium Grade 4 (ASTM F67)
Surface	SA (Sandblasting and Acid etching)	R.B.M (Resorbable Blasting Media)	SLA (Grit blasting, acid etched SLA surface)
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
Substantial Equivalence Statement	Same material, indication for use, and similar design as MS System (K083067), except for surface treatment. Surface treatment is similar to Straumann Dental Implants (K061176).	(Reference for comparison)	(Reference for comparison)

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. The submission states "No clinical studies are submitted." The evaluation relies on comparison to predicate devices and nonclinical testing.
Data provenance: For mechanical testing ("Fatigue testing"), it is conducted according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment." This implies a standardized laboratory test, not patient data.

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):

Not applicable. No clinical test set requiring expert ground truth assessment was submitted.

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

Not applicable. No clinical test set requiring adjudication was submitted.

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. This device is a dental implant, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant here.

6. 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.

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

Not applicable. For the comparative evaluation, the "ground truth" is established by the documented characteristics, materials, and intended uses of the legally marketed predicate devices. For nonclinical testing (fatigue), the ground truth is adherence to established engineering standards and performance requirements for dental implants.

8. The sample size for the training set:

Not applicable. No machine learning or AI component requiring a training set is involved.

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

Not applicable. No machine learning or AI component requiring a training set is involved.

Summary

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K122171

DSSTEM Implant Co., Ltd 507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea

Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

510(k) Summary

NOV 1 6 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 13, 2012

Company and Correspondent making the submission:

Submitter's Name :
Address :
Contact :
Phone:
Correspondent's Name:
Address:
Contact:
Phone:

Device :

Trade or (Proprietary) Name : Common or usual name :

Classification Name :

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea Mr. Hee Kwon Son +82 51 850 2575

HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Patrick Lim 888 678 0001

MS SA Implant System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

3. Predicate Device:

MS System, OSSTEM Implant Co., Ltd, K083067 Straumann Dental Implants, Institut Straumann AG, K061176

4. Description:

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Image /page/1/Figure/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea. The telephone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com.

The MS SA Implant System is substantially equivalent in design, function and intended use to the MS System, OSSTEM Implant Co., Ltd, K083067

The MS SA Implant System is substantially equivalent in surface treatment to the Straumann Dental Implants, Institut Straumann AG, K061176

	MS SA Implant System(Narrow Ridge)	Predicate devices
		MS System(Narrow Ridge)	Straumann DentalImplants
Design	Image: MS SA Implant System (Narrow Ridge)	Image: MS System (Narrow Ridge)	Image: Straumann Dental Implants
510(K) No.	New device	K083067	K061176
Intended use	The MS SA Implant (NarrowRidge) is intended to use inthe treatment of missingmandibular central andlateral incisors to supportprosthetic device, such asartificial teeth, in order torestore chewing function inpartially edentulous patients.The MS SA Implant (NarrowRidge) is intended for singleuse only. It is intended fordelayed loading.	The MS System (NarrowRidge) is intended to usein the treatment of missingmandibular central andlateral incisors to supportprosthetic device, such asartificial teeth, in order torestore chewing functionin partially edentulouspatients. MS System(Narrow Ridge) areintended for single useonly.	Straumann Regular Neckand Narrow Neck implantsare intended for immediateplacement and function onsingle-tooth and/or multipletooth applications whengood primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Multiple tooth applicationsmay be rigidly splinted. Inthe case of edentulouspatients, four or moreimplants must be used.The Straumann RegularNeck Implants are intendedfor surgical placement inthe maxillary and/ormandibular arches toprovide support forprosthetic restorationsin edentulous or partiallyedentulous patients.
Structure
- SA(Sandblasting and Acid etching).- Threaded Body Design- One Body Implant		- R.B.M (Resorbable Blasting Media).- Micro Thread Design.- Threaded Body Design- One Body Implant	-Single Thread-Straight body Type-Non-submerged fixture
Thread bodyDiameter (D)	2.5, 2.9	2.5, 3.0	3.3~4.8
Length (mm)of thread	8.5, 10.0, 11.5, 13.0	8.5, 10.0, 11.5, 13.0, 15.0	6.0~16.0
Material ofFixture	Titanium alloy Ti-6Al-4V(ASTM F 136)	Titanium alloy Ti-6Al-4V(ASTM F 136)	Pure Titanium Grade 4(ASTM F67)
Surface	SA(Sandblasting and Acidetching).	R.B.M (ResorbableBlasting Media).	SLA(Grit blasting, acidetched SLA surface)
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
S E	The MS SA Implant System (Narrow Ridge) has the same material, indication for use and similar design as the MS System (Narrow Ridge) (K083067) except surface treatment. but the surface treatment of The MS SA Implant System (Narrow Ridge) is the similar with surface treatment of Straumann Dental Implants (K061176)
	MS SA Implant System(Denture)	Predicate devices
		MS System(Denture)	Straumann DentalImplants
	Design	Image: MS SA Implant System (Denture)	Image: MS System (Denture)
510(K) No.	New device	K083067	K061176
Intended use	The MS SA Implant(Denture) is intended to beplaced in the bone of theupper or lower jaw arches toprovide support of theprosthetic devices to restorethe patient's chewingfunction, including thedenture stabilization. TheMS SA Implant (Denture) isintended for single use only.	The MS System (Denture)is intended to be place in thebone of the upper or lowerjaw arches to providesupport the prostheticdevices to restore thepatient's chewing function,including the denturestabilization. MS System(Denture) is intended forsingle use only.	Straumann Regular Neckand Narrow Neck implantsare intended for immediateplacement and function onsingle-tooth and/or multipletooth applications whengood primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Multiple tooth applicationsmay be rigidly splinted. Inthe case of edentulouspatients, four or moreimplants must be used.The Straumann RegularNeck Implants are intendedfor surgical placement inthe maxillary and/ormandibular arches toprovide support forprosthetic restorationsin edentulous or partiallyedentulous patients forsingle-stage or two-stagesurgery. The StraumannNarrow Neck implants areintended for surgicalplacement in the maxilla ormandible to serve as a basefor prostheticreconstructions.Specifically, the Narrow
			Neck implant is indicatedfor replacement of singlelateral incisors in themaxilla and lateral andcentral incisors in themandible. It is particularlyintended for those areaswhere the interdental spaceis extremely limited(minimum 5 mm) andwhere vestibule-oral bone isrestricted (minimum 5 mm).The Narrow Neck implantcan also be used as asupport for a full archimplant-born restoration,but only in conjunction witha standard Straumann 4.1mm dental implant.
Structure	- SA(Sandblasting and Acidetching).- Ball-shaped suits forO-Ring attachment.- 2/4mm can be usedaccording to gingivalheight.- Threaded Body Design	- R.B.M (ResorbableBlasting Media).- Ball-shaped suits forO-Ring attachment.- 2/4mm can be usedaccording to gingivalheight.- Micro Thread Design.- Threaded Body Design	-Single Thread-Straight body Type-Non-submerged fixture
Thread bodyDiameter (D)	2.5, 2.9	2.0, 2.5, 3.0	3.3~4.8
Length (mm)of thread	8.5, 10.0, 11.5, 13.0	8.5, 11.5	6.0~16.0
Material ofFixture	Titanium alloy Ti-6Al-4V(ASTM F 136)	Titanium alloy Ti-6Al-4V(ASTM F 136)	Pure Titanium Grade 4(ASTM F67)
Surface	SA(Sandblasting and Acidetching).	R.B.M (ResorbableBlasting Media).	SLA(Grit blasting, acidetched SLA surface)
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
SE	The MS SA Implant System (Denture) has the same material, indication for use and similardesign as the MS System (Denture) (K083067) except surface treatment. but thesurface treatment of The MS SA Implant System (Denture) is the similar with surfacetreatment of Straumann Dental Implants (K061176)

- Substantial Equivalence Matrix

QS-QI-505-3(Rev.0)

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K122171

Image /page/2/Picture/1 description: The image shows the logo for Osstem Implant. The logo is in black and white and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller font. There is a registered trademark symbol next to the word "OSSTEM".

OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

{3}------------------------------------------------

OSSTEM°
IMPLANT

OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

QS-QI-505-3(Rev.0)

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Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in bold, sans-serif font on the top line. Below that, the word "IMPLANT" is in a smaller, sans-serif font.

OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

5. Indication for use:

Letter(8.5 X 1 In)

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Image /page/5/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in a bold, sans-serif font, with the letters slightly overlapping each other. Below the word "OSSTEM", the word "IMPLANT" is written in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent a company that specializes in dental implants.

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea

Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

The MS SA Implant (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device; such as artificial teeth, in order to restore chewing function in partially edentulous patients. The MS SA Implant (Narrow Ridge) is intended for single use only. It is intended for delayed loading.

1. Review:
  The MS SA Implant System has similar material, indication for use, design and technological characteristics as the predicate device.

The MS SA Implant System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

1. Summary of nonclinical testing
  Fatigue testing was considered according to the "Guidance for industry and FDA staff

Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the MS SA Implant system

1. Summary of clinical testing No clinical studies are submitted

9. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act. 21 CFR Part 807, and based on the information provided in this premarket notification Osstem Implant Co., Ltd. concludes that the MS SA Implant System is substantially equivalent to the predicate devices as described herein.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 a stylized emblem featuring a symbol that resembles an abstract human form or a caduceus-like design.

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

November 16, 2012

OSSTEM Implant Company, Limited C/O Mr. Patrick Lim Manager HiOSSEN Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K122171

Trade/Device Name: MS SA Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 25, 2012 · Received: September 28, 2012

Dear Mr. Lim:

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 Eederal Register.

{7}------------------------------------------------

Page 2 - Mr. Lim

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,

DN: r=US o=1) S. Government ou=HHS 0.9.2342.19200300.100.1.1=1300092402

Anthony D. Watson, B.S., M.S., M.B.A. 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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K122171

OSSTEM Implant Co., Ltd #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

510(k) Number K 100217

Device Name : MS SA Implant System

Indication for use : The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. It is intended for delayed loading.

The MS SA Implant (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The MS SA Implant (Narrow Ridge) is intended for single use only. It is intended for delayed loading.

X Prescription Use (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Mary S. Runn Marv S. Runner DA. Ou=People, cn=Mary 5, Run

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

】 -

510(k) Number: K12217 1

OS-QI-505-2(Rev.0)

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.