The TS Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

TS Fixture System is compatible with abutment in the ET/SS Implant System

Device Description

The TS Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

Fixture is available in various lengths 7.0 to 15.0mm and diameters 3.5 to 6.8mm (TSII SA Fixture : 3.5, 4.2, 4.4, 4.9 / TSIII SA Fixture: 3.75, 3.77, 4.2, 4.25, 4.6, 4.63, 4.65, 5.05, 5.08, 5.1 / TSIII SA Ultra-Wide Fixture : 5.92, 5.95, 6, 6.8) according to the anatomical situation.

Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.

The TS Fixture 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental implant system (TS Fixture System). It aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through the concept of "substantial equivalence" to predicate devices. The performance characteristics of the TS Fixture System are evaluated against those of the predicate devices. The key performance criteria for this type of device are primarily related to mechanical integrity (fatigue strength) and biocompatibility.

Acceptance Criteria (Inferred from Substantial Equivalence and Predicate Devices)	Reported Device Performance (TS Fixture System)
Material Composition: Pure Titanium Grade 4 (ASTM F67)	Conforms: Made of Pure Titanium Grade 4 (ASTM F67). This is identical to the predicate devices (HGII Fixture System, GSIII System, ETIII SA Fixture System, ETIII SA Ultra wide Fixture).
Surface Treatment: (SA - Sandblasting and Acid etching)	Conforms: The TS Fixture System uses SA (Sandblasting and Acid etching) surface treatment. This is identical to the ETIII SA Fixture System (K101096) and ETIII SA Ultra wide Fixture (K103537). While different from HGII (RBM) and GSIII (RBM), the submission asserts equivalence based on the ETIII SA system.
Design Characteristics: (e.g., Internal Hex-connected, submerged fixture, body shape, cutting edges, body diameter, length)	Conforms: The TS Fixture System has an Internal Hex-connected, submerged fixture with tapered and straight body shapes and 4-sided cutting edges with self-tapping. Its dimensions (body diameter 3.5-5.1mm; length 7.0-15mm) are comparable to the ranges of the predicate devices, sometimes falling within one predicate's range or being a combination thereof. For the "TSIII SA Ultra-Wide Fixture" variant, design, diameter (5.92-6.8mm) and length (7.0-12.5mm) are also presented as comparable to its specific predicate (ETIII SA Ultra wide Fixture). The submission states "similar design" compared to predicates.
Intended Use: For partially/fully edentulous mandibles/maxillae, single/multiple-unit restorations, delayed loading.	Conforms: The intended use statement is essentially identical to the predicate devices, supporting single or multiple-unit restorations (cemented, screw, overdenture), and final/temporary abutment support for fixed bridgework, with delayed loading.
Biocompatibility: Meet applicable international/US regulations.	Conforms: "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." (No specific data or reports are summarized beyond this statement.)
Fatigue Strength: Performance equivalent to predicate devices.	Conforms: Fatigue testing was conducted according to FDA guidance (worst-case scenario of GSIII Fixture/HGII Fixture with an angled abutment, supporting TSIII SA Fixture and TSII SA Fixture). The conclusion is that the submitted fatigue test result is sufficient "as a proof of TS Fixture system" due to shared material and similar design with GSIII Fixture and HGII Fixture. Note: No specific numerical performance values (e.g., load cycles at specific force) are provided in this summary, but the conclusion implies successful demonstration of equivalence.
Sterilization: Radiation Sterile	Conforms: Radiation Sterile, identical to all predicate devices.
Shelf Life: 8 years	Conforms: Shelf life of 8 years. Longer than the 5 years reported for all predicate devices; however, a longer shelf life would generally not be a basis for non-equivalence unless it impacted safety or effectiveness adversely, which is not indicated.

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

Sample Size for Test Set: Not explicitly stated as a separate "test set" for clinical performance. The nonclinical testing (fatigue testing) implicitly involves mechanical test samples. No specific number for these samples is provided in this summary.
Data Provenance: The fatigue testing was conducted by or for OSSTEM Implant Co., Ltd., which is based in Republic of Korea. The report is a 510(k) submission to the US FDA. The data itself is non-clinical bench testing data, not human clinical data.

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

This information is not applicable as the submission relies on non-clinical testing (fatigue and biocompatibility) and comparison to predicate devices, not on expert consensus or adjudication of a test set in the way a diagnostic AI device would. The "ground truth" for non-clinical testing is typically defined by engineering standards and measurement accuracy.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above. The evaluation of mechanical fatigue data would involve standard engineering analysis and report generation, not a consensus-based adjudication process.

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

No. A MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission is for a dental implant (a physical medical device) and does not involve image reading or diagnostic interpretation.

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

No. This question is not applicable as the device is a physical dental implant, not a software algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance evaluation hinges on:

Engineering Standards and Specifications: For mechanical fatigue testing, the "ground truth" is adherence to established standards (e.g., ISO, ASTM) and successful completion of test cycles without failure, relative to the performance of predicate devices. The "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" serves as a key reference for methodology.
Biocompatibility Standards: For biocompatibility, the "ground truth" is compliance with applicable international and US regulations, typically demonstrated through standardized in vitro and in vivo tests (e.g., ISO 10993 series).
Predicate Device Characteristics: The ultimate "ground truth" in a 510(k) submission is the demonstration of substantial equivalence to already legally marketed devices.

8. The Sample Size for the Training Set:

This information is not applicable. Dental implants are physical devices, not machine learning algorithms, and therefore do not have "training sets" in the conventional sense. The design and manufacturing process are informed by engineering principles and previous device designs, but not a data training set.

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

This information is not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

K121995

OSSTEM Implant Co.,

#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

NOV 2 9 2012

510(k) Summary

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

Date: June 15, 2012

Company and Correspondent making the submission:

Submitter's Name :
Address :
Contact :
Phone:
Correspondent's Name:
Address:
Contact:
Phone:
1. 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

TS Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

3. Predicate Device:

The HGII Fixture System, HIOSSEN Inc., Ltd. K090237 The ETIII SA Fixture System, HIOSSEN Inc., K101096 The GSIII System, Osstem Implant Co., Ltd, K091208 The ETIII SA Ultra wide Fixture, HIOSSEN Inc., K103537

4. Description:

The TS Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

Fixture is available in various lengths 7.0 to 15.0mm and diameters 3.5 to 6.8mm (TSII SA Fixture : 3.5, 4.2, 4.4, 4.9 / TSIII SA Fixture: 3.75, 3.77, 4.2, 4.25, 4.6, 4.63, 4.65, 5.05,

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

Letter(8.5 X 11in)

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in bold, sans-serif font, with the letters slightly overlapping. Below "OSSTEM" is the word "IMPLANT" in a smaller, lighter font. There is a small circle to the upper right of the word "OSSTEM".

OSSTEM Implant Co., Lt #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

5.08, 5.1 / TSIII SA Ultra-Wide Fixture : 5.92, 5.95, 6, 6.8) according to the anatomical situation.

Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.

The TS Fixture System is substantially equivalent in design, function and intended use to the HGII Fixture System of HIOSSEN Inc. (K090237), the ETIII SA Fixture System of HIOSSEN Inc.(K101096), The GSIII System of Osstem Implant Co., Ltd(K091208) and The ETIII SA Ultra wide Fixture of HIOSSEN Inc.(K103537)

- Substantial Equivalence Matrix

		Predicate devices				TSIII SA Ultra-Wide Fixture	Predicate devices
	TS Fixture System	HGII FixtureSystem	GSIII System	ETIII SAFixture System			ETIII SA Ultra wide Fixture
Design					Design	Image: TSIII SA Ultra-Wide Fixture	Image: ETIII SA Ultra wide Fixture
510(K) No.	New Device	K090237	K091208	K101096	510(K) No.	New Device	K103537
Intended use	The TS Fixture Systemis designed for dentalimplant surgery; it isplaced on the maxillaryor mandibular alveolarbone through a surgicalprocedure, and afterosseointegration withthe alveolar bone, it canreplace a lost tooth byconnecting theabutment post. The TSFixture System isindicated for use inpartially or fullyedentulous mandibles	The HG II FixtureSystem is indicatedfor use in partiallyor fully edentulousmandibles andmaxillae, in supportof single ormultiple-unitrestorationsincluding;cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediate	The GS III Systemis indicated for usein partially or fullyedentulousmandibles andmaxillae, in supportof single ormultiple-unitrestorationsincluding;cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediate	ETIII SA FixtureSystem is indicatedfor use in partiallyor fully edentulousmandibles andmaxillae, in supportof single ormultiple-unitrestorationsincluding ;cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediate	Intended use	The TSIII SA Ultra-Wide Fixture is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.	The ETIII SA Ultra wide System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
	of single or multiple-unit restorationsincluding; cementedretained, screwretained, or overdenturerestorations, and finalor temporary abutmentsupport for fixedbridgework. It isintended for delayedloading.	for fixedbridgework.The HG II FixtureSystem is for singleand two stagesurgicalprocedures. It is notforimmediate load.	for fixedbridgework.The GS III Systemis for single andtwo stage surgicalprocedures. It is notfor immediateload.	support for fixedbridgework. TheETIII SA FixtureSystem is for singleand two stagesurgicalprocedures. It is notfor immediate load.The Ultra wideFixture System isintended to be usedin the molar region.	Surgery type	One or two stage Surgery	One or two stage Surgery
Surgery type	One or two stageSurgery	One or two stageSurgery	One or two stageSurgery	One or two stageSurgery	Structure	- Internal Hex-connected- Submerged Fixture- Tapered body shape and straight body shape- 4 sided cutting edge with self-tapping	- Internal Hex-connected- Submerged Fixture- Tapered body shape and straight body shape- 4 sided cutting edge with self-tapping
Structure	- Internal Hex-connected- Submerged Fixture- Tapered body shapeand straight body shape- 4 sided cutting edgewith self-tapping	- Internal Hex-connected- SubmergedFixture- Straight bodyshape- 4 sided cuttingedge with self-tapping	- Internal Hex-connected- SubmergedFixture- Tapered bodyshape and- 4 sided cuttingedge with self-tapping	- SubmergedFixture- Self tapping- InternalHexagonalconnection- Taper Body	Body Diameter (D)	5.92, 5.95, 6, 6.8	5.9~6.82
BodyDiameter(D)	TSII SA Fixture:3.5, 4.2, 4.4, 4.9TSIII SA Fixture:3.75, 3.77, 4.2, 4.25,4.6, 4.63, 4.65, 5.05,5.08, 5.1	3.5~4.85	3.7~5.1	3.75~5.05	Length (mm)	7.0~12.5	7.2~12.7
Length (mm)	7.0~15	7.2~15.2	7.0~15.0	7.2~15.2	Material of Fixture	Pure Titanium Grade 4 (ASTM F67)	Pure Titanium Grade 4 (ASTM F67)
Material ofFixture	Pure Titanium Grade 4(ASTM F67)	Pure TitaniumGrade 4(ASTM F67)	Pure TitaniumGrade 4(ASTM F67)	Pure TitaniumGrade 4(ASTM F67)	Surface	SA (Sandblasting and Acid etching)	SA (Sandblasting and Acid etching)
Surface	SA	RBM	RBM	SA	Sterilization	Radiation Sterile	Radiation Sterile
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile	Radiation Sterile	Shelf life	8years	5years
Shelf life	8years	5 years	5 years	5 years	S E	The TSIII SA Ultra-Wide Fixture has the same material, surface treatment, indication for use and similar design as the ETIII SA Ultra wide Fixture (K103537)
S. E.	The TS Fixture System has the same material, indication for use and similar design as theHGII Fixture System (K090237) and GSIII System (K091208) except surface treatment. butthe surface treatment of TS Fixture System is the same with surface treatment of ETIII SAFixture System (K101096)

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

Letter(8.5 X 11in)

{2}------------------------------------------------

Image /page/2/Picture/0 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, simpler font. There is a circle above and to the right of 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

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

Letter(8.5 X 11in)

{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

A The School States States of Article

(6)

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The logo is in black and white, with the word "OSSTEM" in large, bold letters. Below the word "OSSTEM" is the word "IMPLANT" in smaller letters. There is a degree symbol to the right of 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

5. Indication for use :

TS Fixture System is compatible with abutment in the ET/SS Implant System

1. Review :
  The TS Fixture System has same material and indication for use and similar design and technological characteristics as the predicate device.

The TS Fixture 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.

7. 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 GSIII Fixture/ the HGII Fixture and an angled abutment in support of the TSIII SA Fixture and TSII SA Fixture. TS Fixture System has same material and similar design as the GSIII Fixture and the HGII Fixture . Therefore, submitted fatigue test result can be used as a proof of TS Fixture system

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 TS Fixture System is substantially equivalent to the predicate devices as described herein

{5}------------------------------------------------

Image /page/5/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.

Public Health Service

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

November 29, 2012

Osstem Implant Company, Limited C/O Mr. Patrick Lim Hiossen, Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K121995

Trade/Device Name: TS Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II · Product Code: DZE Dated: November 9, 2012 . Received: November 23, 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 Federal Register.

{6}------------------------------------------------

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kwame O. Ulmer

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

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

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 121995

Device Name : TS Fixture System

Indication for use : The TS Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

TS Fixture System is compatible with abutment in the ET/SS Implant System

Prescription Use X (Per 21CFR801 Subpart D)

Over-The-Counter Use OR (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)

Susan Runner DDS, MA
2012.11.29
12:46:27 -05'00'

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

510(k) Number:

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

Letter(8.5 X 1 l in)

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.