The Kisses Plus Implant System is indicated for use in partially or fully edentulous mandibles and maxilla, 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.

The Kisses Plus Implant System is for single and two stage surgical procedures. It is for delayed loading.

Device Description

Kisses Plus Implant System offers three different types of implants: Double Hex, and Kisses Single Hex. The Double Hex type has the doubled hex part to be coupled to the superstructure, whereas, the Single Hex type and Kisses Single Hex type has single hex part.

The Double Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers double hex type.

The Single Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers single hex type.

The Kisses Single Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers single hex type.

Kisses Plus Implant System also includes the following components: Angled abutment, Duplex Abutment, Duplex Milling Abutment, Simplex Abutment, Temporary Abutment, Solid Screw Abutment, Ball Abutment, Ball Cap, Cover Screw, Healing Abutment.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the "Kisses Plus Implant System," and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might find for a novel diagnostic AI algorithm.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement, and ground truth types are not applicable or not explicitly detailed in this type of regulatory submission for a dental implant system.

Instead, the document details physical and functional characteristics to show that the new device is as safe and effective as existing, legally marketed devices.

Here's an attempt to answer your questions based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of acceptance criteria with corresponding device performance metrics in the way you might expect for a diagnostic AI. Instead, it compares the subject device's characteristics to those of predicate devices to establish substantial equivalence. The "performance" here refers to meeting safety and effectiveness standards through material composition, design similarities, and successful non-clinical testing.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary from text)
Material Composition	Ti Gr.4 (ASTM F67) - Same as predicates
Surface Treatment	SLA Treatment - Same as predicates
Sterility	Yes (Gamma Radiation) - Same as predicates
Mechanical Integrity	Fatigue (ISO 14801) - Test performed, supported substantial equivalence
Mechanical Integrity	Rotational shear strength - Test performed, supported substantial equivalence
Mechanical Integrity	Screw loosening torque tests - Test performed, supported substantial equivalence
Dimensions	Diameter: 3.8 – 5.5 mm, Length: 7-14.5 mm - Within range of predicate(s)
Shelf Life	Five years - Validated through accelerated testing
Biocompatibility	Deemed biocompatible due to identical materials/processes as previously cleared predicate (K142813)
Sterilization Validation	Conforms to ISO 11137 (gamma) and ISO 17665-1/-2 (steam)
General Safety/Function	Visual inspection, Dimension, Packing inspection, Adaption accuracy, Marginal adaptation, Compressive strength - Tests performed, implicitly met criteria

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

Sample Size for Test Set: Not explicitly stated in terms of a "test set" for performance evaluation of an AI algorithm. The non-clinical tests (e.g., fatigue, rotational shear strength) inherently involve a sample size of physical devices, but the specific number tested for each criterion is not detailed.
Data Provenance: Not applicable as this is a physical medical device, not an AI algorithm processing patient data. The tests were likely conducted in a controlled laboratory environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a physical dental implant device, not a diagnostic algorithm requiring expert-established ground truth from medical images or patient data. The "ground truth" for this device's performance is established through engineering standards, material specifications, and mechanical testing.

4. Adjudication method for the test set

Not Applicable. This is a physical dental implant device, not a diagnostic algorithm where adjudication of results by multiple experts would typically occur. The non-clinical tests are performed according to established standards.

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 is a physical dental implant device and does not involve human readers or AI assistance in the context of diagnostic interpretation.

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

Not Applicable. This is a physical dental implant device, not an algorithm.

7. The type of ground truth used

Engineering Standards and Specifications: The "ground truth" for the performance of this dental implant is based on established international standards (e.g., ISO, ASTM), material properties, and the demonstrated performance of its predicate devices. The non-clinical tests verify that the device meets these engineering and safety benchmarks.

8. The sample size for the training set

Not Applicable. This is a physical dental implant device, not an AI algorithm that requires a training set.

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

Not Applicable. This is a physical dental implant device, not an AI algorithm that requires a training set with established ground truth.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

ACHIMHAI Medical Corporation % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620

Re: K172630

Trade/Device Name: Kisses Plus Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 1, 2018 Received: March 9, 2018

Dear Priscilla Chung:

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.

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);

April 3, 2018

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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 mediation-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

forTina 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 SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K172630

Device Name Kisses Plus Implant System

Indications for Use (Describe)

The Kisses Plus Implant System is indicated for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The Kisses Plus Implant System is for single and two stage surgical procedures. It is for delayed loading.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary (K172630)

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 04/03/2018

1. Submitter

ACHIMHAI Medical Corporation 28, Namyang-ro, 930beon-gil, Namyang-eup Hwaseong-si, Gyeonggido, Republic of Korea, 18255

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Trade Name: Kisses Plus Implant System ●
Common Name: Dental Implant System
Classification Name: Endosseous Dental Implant
Product Code: DZE, NHA ●
Classification regulation: 21CFR872.3640 ●

4. Predicate Device:

● Primary Predicate Device:

TS Fixture System (K121995) by OSSTEM Implant Co., Ltd. (for fixtures) SimpleLine II Abutment System (K112045) by Dentium (for abutments)

Reference Device: ●

Biogenesis Implant System - Kisses (K142813) by Achimhai Medical Corporation EZ Plus Implant System (K070562) by Megagen

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5. Description:

3.8mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L ●
4.2mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L .
4.6mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L ●
5.1mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L ●
. 5.5mm Dia. x 7mm L. 8mm L. 9.5mm L. 11mm L. 12.5mm L. 14.5mm L

3.8mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L
4.2mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L ●
4.6mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L ●
5.1mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L ●
5.5mm Dia. x 7mm L. 8mm L. 9.5mm L. 11mm L. 12.5mm L. 14.5mm L .

3.8mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L ●
4.2mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L ●
4.6mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L ●
5.1mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L
5.5mm Dia. x 7mm L, 8mm L, 9.5mm L, 11mm L, 12.5mm L, 14.5mm L .

Kisses Plus Implant System also includes the following components.

-Angled abutment
The abutments and the screws below are manufactured by our company were cleared under K142813 and can be used with the subject fixtures.
Duplex Abutment -
-Duplex Milling Abutment
-Simplex Abutment
Temporary Abutment -

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Solid Screw Abutment -
-Ball Abutment
Ball Cap -
Cover Screw -
Healing Abutment -

6. Indication for use:

The Kisses Plus Implant System is for single and two stage surgical procedures. It is for delayed loading.

7. Basis for Substantial Equivalence

	Subject Device	Primary Predicate Device	Reference Device
510(K) Number	-	K121995	K142813
Device Name	Kisses Plus Implant System	TS Fixture System	Biogenesis Implant System -Kisses
Manufacturer	Achimhai Medical Corporation	OSSTEM Implant Co., Ltd.	Achimhai Medical Corporation(Note: Our company namehas changed from Biogenesisto Achimhai.)
Type	Internal hex	Internal hex	Internal hex
Design & Size Range	(Double HexSingle HexKisses Single Hex)Diameter: 3.8 – 5.5 mmLength: 7-14.5 mm	Diameter: 3.5 – 6.8 mmLength: 7-15 mm	Diameter: 3.8 – 5.5 mmLength: 7-14.5 mm
Differences in design	Taper angle : 3°Image: Taper angle 3 degrees	Taper angle : about 1°Image: Taper angle about 1 degree	Taper angle : 3°Image: Taper angle 3 degrees
	Cutting edge	Cutting edge	Cutting edge
	Image: Platform edge	Image: Platform edge	Image: Platform edge
	Image: Thread shape	Image: Thread shape	Image: Thread shape
Indications for Use	The Kisses Plus ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple-unit restorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate abutmentsupport for fixed bridgework.	The TS Fixture System isindicated for use in partially orfully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutment supportfor fixed bridgework.	The Biogenesis ImplantSystem -Kisses is indicatedfor use in partially or fullyedentulous mandibles andmaxillae, in support of singleor multiple-unit restorationsincluding; cemented retained,screw retained, oroverdenture restorations, andterminal or intermediateabutment support for fixedbridgework.
	The Kisses Plus ImplantSystem is for single and twostage surgical procedures. Itis for delayed loading.	It is intended for delayedloading. TS Fixture System iscompatible with abutment inthe ET/SS Implant System.	The Biogenesis ImplantSystem - Kisses is for singleand two stage surgicalprocedures. It is for delayedloading.
Principle ofOperation	The device is a substructureof a dental implant system. Itconsists of the hex part to becoupled to the superstructure,the single thread part to befixed to the bone, and thecutting edge part with the self-tapping function.	The device is a substructureof a dental implant system. Itconsists of the hex part to becoupled to the superstructure,the single thread part to befixed to the bone, and thecutting edge part with the self-tapping function.	The device is a substructureof a dental implant system. Itconsists of the hex part to becoupled to the superstructure,the single thread part to befixed to the bone, and thecutting edge part with the self-tapping function.
Material Composition	Ti Gr.4(ASTM F67)	Ti Gr.4(ASTM F67)	Ti Gr.4(ASTM F67)
Surface Treatment	SLA Treatment	SLA Treatment	SLA Treatment
Sterile	Yes	Yes	Yes
Sterilization Method	Gamma Radiation	Gamma Radiation	Gamma Radiation

7.1. Fixture

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Substantial Equivalence Discussion

Kisses Plus fixture is substantially equivalent to the predicate devices in terms of indications for use and technical characteristics. They have similar design that all the devices are two piece type fixtures with thread part to be fixed to the bone. They are made of the same material and all have cutting edge part for self-tapping function. The size range of the primary predicate device encompasses the size range of the subject device. There are slight differences in design such as taper angle, cutting edge shape, platform edge shape, thread shape. The taper angle of the subject device is different from the primary predicate device, but the same as the reference device.

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The cutting edge of subject device has spiral shape. On the other hand, that of primary predicate device has pocket shape. However, the function of the cutting edge is the same as that of forming the path through which the bone is scratched when the fixture is placed. The reference device also has spiral cutting edge.

The platform edge of the subject device has different shape from the reference device but is the same as the primary predicate device.

Per the thread design, all the devices have the same pitch (0.8mm) but the angle of the thread is slightly different. However this does not raise an issue in effectiveness with this small difference.

7.2. Abutments
510(K) Number	Subject Device	Primary Predicate Device	Reference Device
		K112045	K070562
Device Name	Kisses Plus Implant System	SimpleLine II Abutment System	EZ Plus Implant System
Manufacturer	Achimhai Medical Corporation	Dentium	Megagen
Type	Internal	Internal	Internal
Indications for Use	The Kisses Plus Implant 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.The Kisses Plus Implant System is for single and two stage surgical procedures. It is for delayed loading.	The SimpleLine II Abutment system is intended for use as an aid in prosthetic rehabilitation.	The EZ Plus Implant Systems are intended to be surgically placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. Large angle abutments (e.g. 25°) on small diameter implants of the EZ Plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strength of the implant.
Principle of Operation	The abutments are to be coupled to the fixtures to make temporary or final prosthesis.	The abutments are to be coupled to the fixtures to make temporary or final prosthesis.	The abutments are to be coupled to the fixtures to make temporary or final prosthesis.
Abutment 1- Angled Abutment
Design & Size Range	Image: HexHexImage: Non-HexNon-HexAngle : 15-25°Diameter: 4.0-5.5mmPost Height : 8.0mmGingival Height: 2.0-6.0mm	Image: OctaOctaAngle : 15-25°Diameter: 3.8-6.5mmPost Height : 9.0mmGingival Height: 1mm	Image: TripTripImage: Non-TripNon-TripAngle : 15-25°Diameter: 4.0 - 6.0mmPost Height : 7.0mmGingival Height: 2.0 - 5.0mm
Difference in design	Anti-rotation : Hex	Anti-rotation : Octa	Anti-rotation : TripFixture side
Intended Use	Cement retained restoration	Cement retained restoration	Cement retained restoration
Material Composition	Ti Gr.4(ASTM F67)	Ti Gr.4(ASTM F67)	Ti Gr.4(ASTM F67)
Surface Treatment	Anodizing coloring - Goldcolor (Entire Body)	No	Anodizing coloring — Goldcolor (Entire Body)
Sterile	No	No	No

7.2. Abutments

510(k) Submission.

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Substantial Equivalence Discussion

The subject Angled Abutment is substantially equivalent to the predicate devices in terms of indications for use and technical characteristics. They are material and have similar design. The size range of the predicate devices encompasses the size range of the subject device. Differences in design are anti-rotation feature. The Anti-rotation serves to prevent the rotation of the

prosthesis in a single case. Each device has its own anti-rotation feature design for the subject device. Octa design for the primary predicate device, and the Trip design for the reference device. Even though the design is different among the devices, this feature serves the same function. Also, the test result of the fatigue test supported substantial equivalence despite this difference.

Substantial Equivalence Discussion

Kisses Plus Implant System is substantially equivalent to the predicate devices in terms of indications for use and technical characteristics. The indications for use statement of the subject device is exactly same as the reference device (K142813) made by our company even in wording. When comparing that of the primary predicate device, the wording, "intended for" has changed to "indicated for" but this change does not constitute a new claim. The subject device also a claim for "single and two stage surgical procedures" which the primary predicate device does not have, but the reference device has the same claim. For the abutments, the subject device mentions "terminal or intermediate abutment" in the indications for use which is different from the primary predicate device that uses the term "final or temporary abutment", however, the meaning of the verbiage is not altered. .

They are made of the same material and have similar design. The size range of the predicate device encompasses the size range of the subject device. There are slight differences in design, however, it is very minor not affecting substantial equivalence. We have performed the fatigue test, material/surface characterization, biocompatibility, sterilization validation, shelf life validation studies to make sure the difference in design does not raise an issue in safety and effectiveness and the test result of the test supported substantial equivalence.

Based on the information and test results provided in submission, we conclude that the subject device is substantially equivalent to the predicate devices.

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8. Non-Clinical Testing

Sterilization validating testing has been performed in accordance with ISO 11137 for ● gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
. Five year of shelf life has been validated through accelerating testing.
. Surface Morphology, Surface Roughness Analysis, and FT-IR Analysis were performed to evaluate the fixture surface characteristics after SLA treatment.
. Other Performance tests: Visual inspection, Dimension, Packing inspection, Sterility, Adaption accuracy, Marginal adaptation, Compressive strength, Fatigue (ISO 14801), Rotational sheer strength, Screw loosening torque tests
. Biocompatibility: The fixtures and the abutments of the subject device are the same as the predicate device (BIOGENESIS IMPLANT SYSTEM, K142813) manufactured by our company in terms of raw materials, surface treatment, sterilization method, and the manufacturing processes. No biocompatibility testing was conducted as no new materials, manufacturing or processes were introduced.

9. Conclusion

The subject devices and the predicate device have the same indications for use and have the same technological characteristics.

Overall, the Kisses Plus Implant System has the following similarities to the predicate device:

- have the same indications for use,
- use the same operating principle,
- incorporate the same design,
- incorporate the same material and the sterilization method.

Based on the similarities, we conclude that the Kisses Plus Implant System is substantially equivalent to the predicate devices.

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.