The JR 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 JR Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

Device Description

The JR Implant system is made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are 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 of the implant has been treated with R.B.M (Resorbable Blast Media). The fixtures are offered in the following length and diameter. There are five different types of abutments offered and they are provided straight only.

AI/ML Overview

The provided text describes a 510(k) summary for the JR Implant System, a dental implant device. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance based on a study of AI performance. The document focuses on demonstrating substantial equivalence to a predicate device through material and biocompatibility testing, rather than a clinical or AI-driven performance study with acceptance criteria.

Therefore, for aspects related to AI performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies, the provided text does not offer the necessary details.

Here's a breakdown of what can and cannot be extracted from the document based on your request:

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

The document does not specify "acceptance criteria" in the context of a performance study for AI or clinical efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" mentioned refers to mechanical and biological properties like biocompatibility and sterilization validation, not clinical outcomes or AI accuracy metrics.

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

Not applicable. No "test set" in the context of an AI study or clinical trial is described. The performance testing mentioned (biocompatibility, sterilization validation, surface treatment analysis) is laboratory-based, not involving human patient data sets.

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. "Ground truth" in the context of expert consensus on a test set is not mentioned, as no such study is described. The testing is related to material properties and biological compatibility.

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

Not applicable. No test set adjudication method is mentioned.

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 study is mentioned. This document is for a dental implant, not an AI diagnostic or assistance tool.

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 consensus, pathology, outcomes data, etc.)

The document describes material and biocompatibility testing. The "ground truth" for these tests would be established by validated laboratory testing procedures and scientific standards (e.g., ISO standards for cytotoxicity). It does not involve expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

Not applicable. No "training set" for an AI model is involved.

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

Not applicable.

Summary of available information related to performance testing:

The device's performance is established through manufacturing and material testing, not through a clinical performance study with AI.

Acceptance Criteria Category	Reported Device Performance (as per document)
Biocompatibility	- ISO Cytotoxicity: Completed, results show non-toxic.
	- ISO Sensitization: Completed, results show non-sensitizing.
	- ISO Intracutaneous reactivity: Completed, results show non-reactive.
Sterilization	- Sterilization validation: Completed (Method: Gamma).
Surface Treatment	- Surface treatment analysis: Completed (Surface: R.B.M (Resorbable Blast Media) for fixtures, Anodizing for abutments, cover screws, healing abutments, temporary abutments).
Material Composition	- Fixture: Titanium 6AL 4V ELI alloy, ASTM F136.
	- Abutment, Cover screw, Healing Abutment, Temporary Abutment: Ti 6Al 4V ELI, ASTM F136.

Study Description:

The document refers to performance testing as a means to demonstrate the safety and effectiveness of the device, particularly focusing on the differences in titanium grade and surface treatment compared to the predicate device. The studies were laboratory-based tests for biocompatibility, sterilization validation, and surface treatment analysis. These tests were conducted to prove that the material differences between the subject device (JR Implant System) and the predicate device (NobelReplace Tapered Conical Connection) do not raise issues in safety and performance.

The data provenance for these laboratory tests would typically be internal to the manufacturer or conducted by certified testing laboratories, likely in South Korea (country of origin of the manufacturer). The studies are not clinical trials and therefore do not have a retrospective or prospective patient data element.

Summary

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510(K) SUMMARY

(K130694)

Submitter / Applicant:

June / 1 8/2014

KJ Meditech Co., Ltd.

959-21 Daechon-dong, Buk-gu, Gwang-ju, 500-470, South Korea Phone : +82-62-972-5476 Fax : +82-62-973-2809

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831 Tel: 714-202-5789 Email: juhee.c@lkconsultinggroup.com

3. Device Name :

Trade Name	:	JR Implant System
Common Names	:	Abutment, Dental, Endosseous implant
Classification Name	:	Implant, Endosseous, Root-Form
Regulation	:	21 CFR 872.3640, DZE

4. Predicate Device :

NobelReplace Tapered Conical Connection (K062566) Manufactured by Nobel Biocare USA LLC

5. Device Description :

510(k) Summary

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KJ Meditech Co., Ltd

other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the implant has been treated with R.B.M (Resorbable Blast Media).

The fixtures are offered in the following length and diameter.

Narrow Platform Fixture: 3.5mm Dia. x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 16.6mm(L)
Regular Platform Fixture : 4.3 mm Dia. x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 13.6mm(L)
Wide Platform Fixture : 5.0mm Dia x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 16.6mm(L)
6.0 Platform Fixture : 6.0mm Dia. x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 13.6mm(L)

There are five different types of abutments offered and they are provided straight only.

Esthetic Abutment
EZ Abutment
Healing Abutment
Cover Screw
Temporary Abutment

5 Intended For Use :

Item	Subject Device	Predicate Device
510(K) Number	N/A	K062566
Device Name	JR Implant System	NobelReplace Tapered Conical Connection
Manufacturer	KJ Meditech Co., Ltd.	Nobel Biocare USA LLC
Indications for Use	Intended for use in partially or fullyedentulous mandibles and maxillae, insupport of single or multiple-unitrestorations including; cement-retained,screw-retained, or overdenture restorations.and terminal or intermediate abutmentsupport for fixed bridgework.	Intended for use in partially or fullyedentulous mandibles and maxillae, insupport of single or multiple-unitrestorations including; cement-retained,screw-retained, or overdenture restorations,and terminal or intermediate abutmentsupport for fixed bridgework.

Design	• Implant Type: Bone Level Implant• Connection Type: Internal tri-lobeconnection• Neck Design: Straight walled neck withmicro-thread provides crestal seal.• Body Design: Tapered design enablesplacement near impringing anatomicalstructures while maximizing prosthetictable diameter for natural emergenceprofile.	• Implant Type: Bone Level Implant• Connection Type: Internal tri-channelconnection• Neck Design: Straight walled neck withcircumferential thread provides crestalseal.• Body Design: Tapered design enablesplacement near impringing anatomicalstructures while maximizing prosthetictable diameter for natural emergence
FixtureAppearance	Image: Implant with RBM Treatment on the fixture body	Image: Implant with TiUnite surface treatment
Fixture SurfaceTreatment	RBM Treatment on the fixture body	TiUnite® surface treatment.
Fixture Material	Ti 6Al 4V ELI, ASTM F136	Pure titanium, ASTM F67
Fixture Sterile	Yes	Yes
Sterilization Method	Gamma	Gamma
Fixture Diameters	3.5mm 4.3mm 5.0mm 6.0mm	3.5mm 4.3mm 5.0mm 6.0mm
Fixture Lengths	8mm - 16.0 mm	8mm - 16.0 mm
Abutment SurfaceTreatment	Anodizing	Anodizing
Abutment material	Ti 6Al 4V ELI, ASTM F136	Pure titanium, ASTM F67
Cover screw SurfaceTreatment	Anodizing	Anodizing
Cover screw material	Ti 6Al 4V ELI, ASTM F136	Pure titanium, ASTM F67
Healing Abut SurfaceTreatment	Anodizing	Anodizing
Healing Abut material	Ti 6Al 4V ELI, ASTM F136	Pure titanium, ASTM F67
Temporary Abut SurfaceTreatment	Anodizing	Anodizing
Temporary Abut material	Ti 6Al 4V ELI, ASTM F136	Pure titanium, ASTM F67
AbutmentType	For Narrow Platform FixtureFor Regular Platform FixtureFor Wide Platform FixtureFor 6.0 Platform Fixture	For Narrow Platform FixtureFor Regular Platform FixtureFor Wide Platform FixtureFor 6.0 Platform Fixture
Cover Screw Type	For Narrow Platform FixtureFor Regular Platform FixtureFor Wide Platform FixtureFor 6.0 Platform Fixture	For Narrow Platform FixtureFor Regular Platform FixtureFor Wide Platform FixtureFor 6.0 Platform Fixture
Healing Abut Type	For Narrow Platform FixtureFor Regular Platform FixtureFor Wide Platform Fixture	For Narrow Platform FixtureFor Regular Platform FixtureFor Wide Platform Fixture
	For 6.0 Platform Fixture	For 6.0 Platform Fixture
Temporary Abutment	For Narrow Platform FixtureFor Regular Platform FixtureFor Wide Platform FixtureFor 6.0 Platform Fixture	For Narrow Platform FixtureFor Regular Platform FixtureFor Wide Platform FixtureFor 6.0 Platform Fixture
Product Code	DZE	DZE

6. Substantial Equivalence :

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KJ Meditech Co., Ltd

510(k) Summary

An - Relation of a 1

Page 3 of 4

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KJ Meditech Co., Ltd

The JR Implant system is substantially equivalent in intended use, design and performance to the predicate devices.

The differences between the subject device and the predicate device are the titanium grade and surface treatment of the fixture; however, testing data such as biocompatibility testing provided in the submission proves that this difference would not raise issues in safety and performance. Therefore, we claim that the proposed device is substantially equivalent to the predicate device.

7. Performance Testing

· Biocompatibility testing on the proposed JR Implant System has been completed.

The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed.

-ISO Cytotoxicity

-ISO Sensitization

-ISO Intracutaneous reactivity

· Sterilization validation and surface treatment analysis were also conducted on JR Implant System.

8. Conclusion

Based on the information provided in this premarket notification KJ Meditech Co., Ltd concludes that the JR Implant System is substantially equivalent to the predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains an emblem of an eagle with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top and left side of the circle.

Public Health Service

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

June 19, 2014

KJ Meditech Co., Ltd. C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 East Chapman Avenue, Suite 110 Fullerton, CA 92833

Re: K130694

Trade/Device Name: JR Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 14, 2014 Received: May 20, 2014

Dear Ms. 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.

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Page 2 - Ms. Chung

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 yours,

Mary S. Runner -S

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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Indication for use Statement

K130694 510(k) Number ( If known ) :

Device Name : JR Implant System

Indication for use :

The JR 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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The JR Implant System is for single and two stage surgical procedures. These systems are intended for delayed loading.

Prescription Use ---------X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter (Part 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)

Sheena A. Green -S 2014.06.19 10:58:57 -04'00'

Indication for use statement

Page 1 of 1

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.