The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

Device Description

An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The IBS Implant System is consists of dental implants, abutments, and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel.

The surface of the system has been treated with RBM (Resorbable Blasted media) to increase junction strength by increasing the area of bone-implant interface.

There are 2 types of fixtures in this system, NR Fix and Magic FC. The NR Fix has diameters in 3.5mm and lengths in 9, 10, 11, 12, 13, 14 mm. The Magic FC has diameters in 4. 4.5. 5.0. 5.5. 6.0. 6.5mm and lengths in 7. 9. 11, 13. 15 mm.

The contained various abutments and accessories in the system are Magic Screw retained type Abutment & protect cap, Healing Abutment, Angled Abutment (hexa, non hexa), Pair Abutment (non hexa), Solid Abutment & Solid abutment cap, Magic abutcoping (transfer type, pick up type), Multiunit abutment, UCLA abutment.

Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use. But healing abutment is supplied sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the IBS Implant System, primarily focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for device performance. As such, much of the requested information regarding specific acceptance criteria, detailed study parameters, ground truth establishment, sample sizes, and expert qualifications for performance evaluation (especially for AI/standalone algorithm performance) is not available in this document.

The document primarily discusses non-clinical data to support substantial equivalence.

Here's an attempt to extract the available information based on your request, followed by acknowledgments of what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of numerical performance thresholds (e.g., specific accuracy, sensitivity, specificity, or success rates) for the device. Instead, the reported "performance" is demonstrated through compliance with recognized standards and successful non-clinical testing to show substantial equivalence.

Acceptance Criteria Category	Specific Criteria (as inferred/stated)	Reported Device Performance (as summarized)
Intended Use	Replace missing teeth to restore chewing function; support single or multiple-unit restorations (cement/screw retained, overdentures, fixed bridgework); one or two-stage surgical procedures; delayed loading.	Matches the predicate device's intended use, demonstrating substantial equivalence.
Material Composition	Fabricated from Ti-6AL-4V Eli (Conforming to ASTM Standard F-136).	Subject device is fabricated from Ti-6AL-4V Eli (Conforming to ASTM Standard F-136), same as predicate.
Sterilization	Sterilization validation performed in accordance with ISO 11137-1:2006, ISO 11137-2:2009.	Sterilization Validation testing performed in accordance with specified ISO standards. Fixtures are supplied sterile; healing abutments are supplied sterile. Other abutments/accessories are non-sterile and require sterilization before use.
Surface Treatment	Surface treated with RBM (Resorbable Blasted media) to increase junction strength by increasing bone-implant interface area.	Surface treatment analysis used. Similar R.B.M. surface as predicate.
Fatigue Resistance	Fatigue test performed under worst-case scenario in accordance with ISO 14801:2007.	Fatigue test performed in accordance with ISO 14801:2007.
Shelf Life	Changed from 2 years to 5 years.	Not explicitly stated as "met" acceptance criteria, but noted as a change in the submission. Implies successful testing to support this change.
General Device Design/Function	Designed, manufactured, and tested in compliance with FDA's "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments."	Device found substantially equivalent, implying compliance with this guidance.

Missing Information (Not available in the provided text):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "non-clinical tests" and "fatigue test" but does not detail the sample sizes (e.g., number of implant samples tested) or data provenance (e.g., from which specific test batches or labs). No human or clinical data is mentioned, so no information on retrospective/prospective human 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 as no human-expert-evaluated test set is described. The "ground truth" for the non-clinical tests would be the established performance metrics or compliance standards.

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

Not applicable as no human-expert evaluation/adjudication is described.

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

No MRMC or AI-assisted study is mentioned. This filing is for a physical dental implant system, not an AI software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable; this is not an AI algorithm.

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

For the non-clinical tests (sterilization, fatigue, surface analysis), the "ground truth" would be established by the specifications of the relevant ISO and ASTM standards and the results obtained from laboratory testing (e.g., successful biological indicator kill for sterilization, passing cycles for fatigue).

8. The sample size for the training set

Not applicable; this is not an AI algorithm.

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

Not applicable; this is not an AI algorithm.

Summary of what the document confirms:

The IBS Implant System received 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. This was supported by:

Matching intended use.
Identical material composition (Ti-6AL-4V Eli conforming to ASTM F-136).
Compliance with non-clinical testing standards including ISO 11137-1:2006, ISO 11137-2:2009 for sterilization validation, and ISO 14801:2007 for fatigue testing.
Similar surface treatment (R.B.M.).
A general statement of being "designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments."

The review process focused on these points to confirm that the new device does not raise new questions of safety and effectiveness compared to the already marketed predicate devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three profiles facing right, representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

May 9, 2016

InnoBioSurg Co., Ltd. c/o Ms. April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K153350

Trade/Device Name: IBS Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 1, 2016 Received: April 8, 2016

Dear Ms. Lee,

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. April Lee

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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 yours,

Tina Kiang
-s

for Erin I. Keith, M.S. 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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Image /page/2/Picture/0 description: The image shows the logo for IBS implant. The logo consists of the letters "IBS" in a bold, dark blue font, followed by the word "implant" in a smaller, dark blue font. Below the word "implant" is the text "Innobiosurg Co.,Ltd" in a smaller, light yellow font. The logo also includes a stylized square with a yellow accent in the upper left corner.

InnoBioSurg Co., Ltd.

44-19, Techno 10-ro Tel. 82- 42-933-2879 / Fax. 8

Indication for Use

K153350 510(K) Number (if known):

Device Name: IBS Implant System

Indication for Use:

Prescription Use

AND/OR

Over-The-Counter

(Part 21 CFR 801 Subpart D)

(Per 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)

Page 1 of 1

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Image /page/3/Picture/1 description: The image shows the logo for IBS Implant InnoBiosurg Co., Ltd. The logo features the letters "IBS" in a bold, dark blue font, with a yellow square in the upper left corner of the "I". To the right of "IBS" is the word "implant" in a smaller, dark blue font. Below "implant" is the text "InnoBiosurg Co., Ltd" in a smaller, light yellow font.

Tel. 82- 42-933-2879 / Fax. 82-42-933-288

510(k) Summary

Submitter

InnoBioSurg Co., Ltd. Bo-reum Yoo 44-19, Techno 10-ro, Yuseong-gu, Daejeon, 34027 Republic of Korea Email: bryoo@ibsimplant.com Tel.+82-42-933-2879 Fax.+82-42-933-2881

Official Correspondent

Withus Group Inc April Lee 2531 Pepperdale Drive Rowland Heights, CA 91748 USA Email:withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

. Trade Name: IBS Implant System
Common Name: Dental Implant System
Classification Name: Endosseous dental implant
Primary Product Code: DZE
Secondary Product Code: NHA
Panel: Dental
Regulation Number: 872.3640
Device Class: Class II ●
Date prepared: 5/2/2016

General Description

The surface of the system has been treated with RBM (Resorbable Blasted media) to increase junction strength by increasing the area of bone-implant interface.

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Image /page/4/Picture/0 description: The image contains the logo for IBS Implant InnoBiosurg Co., Ltd. The logo features a stylized "i" and "G" in a blue square, followed by the text "IBS" in bold, blue letters. To the right of "IBS" is the word "implant" in a smaller, blue font, and below that is "InnoBiosurg Co.,Ltd" in a smaller, lighter font.

InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Kore
00

The purpose of this submission is to add new fixtures (NR Fix, Magic FC), magic screw, healing abutment, angled abutment, pair abutment (non-hexa), screw retained type abutment and solid abutment cap, magic abutcoping, UCLA abutment, and Multi unit abutment. Also, the shelf life of the products is changed from 2 years to 5 years.

Indication for Use

Materials:

The dental implants are fabricated fromTi-6AL-4V Eli (Conforming to ASTM Standard F-136).

Non-Clinical Data:

Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments". Sterilization Validation testing performed in accordance with ISO 11137-1:2006, ISO 11137-2:2009 and surface treatment analysis were used to support the decision of substantial equivalence. Fatigue test was performed under the worst case scenario in accordance with ISO 14801:2007.

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Image /page/5/Picture/0 description: The image is a logo for IBS implant. The logo consists of the letters "IBS" in a bold, sans-serif font, with the "I" having a yellow square in the upper left corner. To the right of "IBS" is the word "implant" in a smaller, sans-serif font. Below "implant" is the text "Innobiosurg Co.,Ltd" in an even smaller, sans-serif font.

Comparison to Predicate Devices:

Comparison of the technological characteristics of the subject device and predicate devices is shown in the Table of Substantial Equivalence below.

Fixture

K140806, IBS Implant System by InnoBioSurg Co., Ltd. .

	Subject Device	Predicate Device
Product Name	IBS Implant System	IBS Implant System
510(k)Product codeClass	NADZEII	K140806DZEII
Manufacturer	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Indication foruse	The IBS Implant System is intended toreplace missing teeth to restore chewingfunction. The IBS Implant System canbe placed in support of single ormultiple-unit restorations including;cement retained, screw retained, oroverdenture restorations, and terminalor immediate abutment support for fixedbridgework. This system is for one ortwo stage surgical procedures. Thissystem is intended for delayed loading.	The IBS Implant System is intended toreplace missing teeth to restore chewingfunction.The IBS Implant System can be placed insupport of single or multiple-unitrestorations including; cement retained,screw retained, or overdenture restorations,and terminal or immediate abutmentsupport for fixed bridgework. This systemis for one or two stage surgical proceduresand not for immediate loading. This systemis intended for delayed loading.
Design	Image: NR FixImage: Magic FC	Image of a screw
Composition ofMaterial	Titanium AlloyTi-6Al-4V EliASTM F136	Titanium AlloyTi-6Al-4V EliASTM F136
Fixture Type	Submerged	Submerged
EndosseousImplant	Tapered, macro threads	Tapered, macro andmicro threads
Components	Various abutments andaccessories	Various abutments and accessories
Range ofDiameters (mm)	NR Fix : 3.5mmMagic Fc : 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm	3.8, 4.3, 4.8, 5.3, 5.8, 6.3 mm
Range ofLengths (mm)	NR Fix : 9, 10, 11, 12, 13, 14mmMagic FC : 7, 9, 11, 13, 15mm	7 mm – 15 mm
ModifiedSurface	R.B.M.	R.B.M.
SurgicalTechnique	1 stage and 2 stage, self tapping	1 stage and 2 stage, self tapping
GammaSterilization	Yes	Yes

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Image /page/6/Picture/0 description: The image shows the logo for IBS Implant InnoBiosurg Co., Ltd. The logo features the letters "IBS" in a bold, dark blue font, with a yellow square in the upper left corner of the "I". To the right of "IBS" is the word "implant" in a smaller, dark blue font, and below that is the text "InnoBiosurg Co., Ltd" in a smaller, light yellow font.

InnoBioSurg

44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea

2) Abutments

K140507, Hiossen Prosthetic System by Osstem Implant Co., Ltd. ●
K123755, Multi Angled Abutment by Osstem Implant Co., Ltd. ●
K111120, CSM Submerged-R Implant System by CSM Implant .

	Subject Device	Predicate devices
		Hiossen Prosthetic System	Multi Angled Abutment	CSM Submerged-R Implant System
Manufacturer	Innobiosurg Co., Ltd	OSSTEM Implant Co., Ltd.	OSSTEM Implant Co., Ltd.	CSM Implant
Design	Image: pair angled solid	Image: Rigid Transfer Angled	Image: Multi Angle
	Image: Multiunit

510(k) No.	-	K140507	K123755	K111120
IntendedUse	IBS prostheticsystem isintended for usewith a dentalimplant toprovide supportfor prostheticrestorations suchas crowns,bridges, oroverdentures.	Hiossen ProstheticSystem is intended foruse with a dentalimplant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures.	Multi AngledAbutment isintended for usea dental implantto providesupport forprostheticrestoration suchas crowns,bridges, oroverdentures.	The CSMSubmerged-Rimplant system isespeciallydesigned for use indental implantsurgery.
Structure	Internal Hex	External Hex	External Hex	Internal Hex
ConnectionType	Internal Hex-Connected	Screw & External Hex-Connected	Screw &External Hex-Connected	Internal Hex-Connected
Diameter (mm)	Solid:3.5/4.0/4.5/5.0/5.5/6.0/6.5Pair:4.0/4.5/5.0/5.5/6.0/6.5Angled:4.0/4.5/5.0UCLA:3.5/4/4.5/5/5.5Multiunit:4.1/4.5/5.0/5.5/6.0/6.5Screw retainedtype:3.5/4.0/4.5/5.5/6.5	Rigid : 4.0/4.6/5.0/6.0/7.0/8.0Transfer : 4.0/4.6/5.0/6.0/7.0/8.0Angled : 4.0/4.3/4.5/4.8/5.5/6.0	Multi Angle : -	UCLA:4.5
G/H Length(mm)	Solid:1.0/2.0/3.0/4.0Pair:1.0/2.0/3.0/4.0Angled:1.0/2.0/3.0/4.0UCLA:1.0/2.0/3.0/4.0Multiunit:1.0/2.0/3.0/4.0/5.	Rigid : 0.5/1.0/2.0/2.5/3.0/4.0/5.0Transfer : 0.5/1.0/2.0/2.5/3.0/4.0/5.0Angled : 0.5/1.0/2.0/2.5 / 3.0 / 4.0	Multi Angle : -	UCLA:0.75
	0Screw retainedtype:0.7/1.5/2.5/3.5/4.5/5.5/6.5
Post Length(mm)	Solid:4.0/6.0/8.0Pair:6.0Angled:0,1.0/2.0/3.0/4.0UCLA:1.0/2.0/3.0/4.0	Rigid : 4.0/5.5/7.0Transfer :4.0/5.5/7.0/8.0Angled : -	Multi Angle : -	UCLA:12
Angle(°)	Angled : 15°/25°/30°Multi Angel :17°/30°	Angled : 17° / 25°	Multi Angle :17°/30°	-
Material ofAbutment	Titanium Alloy(ASTM F 136)Polydiacetate:Cap, UCLATitanium Gr4(ASTM F67) :Multiunitabutment cap	Titanium Alloy (ASTMF 136) : Rigid,Transfer, Angled,Convertible	Titanium Alloy(ASTM F 136) :	P.O.M(UCLA)
Surface	Machine	Machine or TiN	Machine	Machine
Sterilization	Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile

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Image /page/7/Picture/0 description: The image contains the logo for IBS implant. The logo consists of a blue square with a stylized white "iG" inside, followed by the text "IBS implant" in a bold, dark blue font. Below the word "implant" is the text "Innobiosurg Co.,Ltd" in a smaller, lighter font.

InnoBioSurg Co., Ltd.

44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea
11 Tel. 82-42-933-2879 / Fax. 82-42-933-2881

44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea
Tel. 82-42-933-2879 / Fax. 82-42-933-2881

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Image /page/8/Picture/0 description: The image shows the logo for IBS implant. The logo consists of the letters "IBS" in a bold, dark blue font, with a yellow dot above the "I". To the right of "IBS" is the word "implant" in a smaller, dark blue font. Below "implant" is the text "Innobiosurg Co.,Ltd" in a smaller, light yellow font.

44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea
Tel. 82-42-933-2879 / Fax. 82-42-933-2881

Substantial Equivalence Discussion

The IBM Implant System has a substantially equivalent intended use as the identified predicates. The subject device is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments, and they are all constructed of titanium.

The subject and predicate devices are similar in indications, design, technology, functions, dimensions and materials.

The subject device and predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use or substantial equivalence. The differences between the subject device and predicate devices are slight differences in fixture's design and sizes. Differences in technological characteristics do not raise different questions of safety and effectiveness compared to the predicate device.

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Image /page/9/Picture/0 description: The image is a logo for IBS Implant. The logo features the letters "IBS" in a bold, dark blue font, with a stylized icon to the left of the letters. To the right of "IBS" is the word "implant" in a smaller, dark blue font. Below "implant" is the text "Innobiosurg Co., Ltd" in a smaller, lighter font.

InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea

Conclusion

The IBS Implant System, subject device of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, IBS Implant System and its predicate are substantially equivalent.

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.