The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

Device Description

The AnyOne™ Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form endosseous dental implant. The AnyOne™ Internal Implant System contains three types of fixtures, normal thread type, and special length type. This system is made from CP4 Titanium and Ti-6A1-4V-ELI and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). The implants are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of deficiency in implant operation. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw and cement retained restoration. This system has 3.9, 4.3, 4.8, 5.3, 6.3, 7.3mm diameters for normal thread, 4.8, 5.8, 6.8, 7.8, 8.3mm diameters for deep thread, and 4.8, 5.3, 6.3, 7.3mm for special length fixtures. In addition, this system has 7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm lengths for normal thread, 7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm lengths for deep thread, and 7.0mm for special length fixtures.

Contained various abutments in the AnyOne™ Internal Implant System are straight and angled dental implant abutments intended to be connected to the fixture with screw, and to restore a patient's chewing function. The abutments contain Cover Screw, Healing Abutment, EZ Post, Angled Abutment, Milling, Abutment, Zirconia Abutment, Gold Abutment, CCM Abutment, Temporary Abutment, Solid Abutment, Burn-out Cylinder, Octa Abutment, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder, Plastic Cylinder, Flat Abutment, Ball Abutment, Meg-Rhein, ZrGEN Abutment, Multi-unit Abutment, Fuse Abutment, Flat CCM Cylinder, Flat Cover Screw, Flat Healing Abutment, Flat EZ Post Cylinder, Flat Temporary Cylinder, Flat Plastic Cylinder, and Flat Gold Cylinder. The fixtures, prosthetics, and surgical instruments are produced, and packaged separately. All included devices in the system are covered by this submission.

AI/ML Overview

The provided text describes the "AnyOne™ Internal Implant System" and its substantial equivalence to a predicate device, the "XPEED AnyRidge Internal Implant System (K122231)". However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically associated with AI/ML-driven medical devices.

Instead, this document is a 510(k) summary for a traditional medical device (dental implants) and focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "acceptance criteria" here refer to the regulatory requirements for showing substantial equivalence, rather than quantitative performance metrics for an AI algorithm.

Here's an analysis based on the information provided, highlighting why it doesn't fit the requested AI/ML study format:

1. Table of Acceptance Criteria and Reported Device Performance

For this traditional medical device, the "acceptance criteria" are not reported as quantitative performance metrics (like accuracy, sensitivity, specificity for an AI model). Instead, the acceptance criteria for receiving 510(k) clearance are related to demonstrating substantial equivalence to a predicate device in terms of:

Acceptance Criterion (for 510(k) Clearance)	Reported Subject Device Performance / Characteristics
Intended Use Equivalence	"The AnyOne™ Internal Implant System has a substantially equivalent intended use as the identified predicate."
Technological Characteristics Equivalence	"The AnyOne™ Internal Implant System 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." Specific similarities are listed: Materials (CP4 Titanium and Ti-6Al-4V-ELI), Sterilization (Gamma), Angulations of Angled abutments (15, 25°), Product Code (DZE, NHA), Surface treatment (SLA). Differences in specific fixture diameters and heights are present but deemed acceptable under the substantial equivalence pathway.
Safety and Effectiveness	Implied through substantial equivalence to a legally marketed device and compliance with FDA's Class II special controls. "concludes that the AnyOne™ Internal Implant system is safe and effective and substantially equivalent to predicate devices as described herein."
Performance Standard Compliance (if applicable)	Non-Clinical Test Data: "The fatigue testing was performed in accordance with ISO 14801 standard." (This implies the device met the requirements of this standard for fatigue.)

Regarding the specific questions related to AI/ML device studies:

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. This document describes a physical medical device (dental implant), not an AI/ML software. There is no "test set" in the context of an AI algorithm's performance evaluation. The "non-clinical test data" refers to mechanical fatigue testing, not a dataset of patient information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No expert ground truth establishment for a test set is mentioned.

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

Not applicable. No test set or adjudication for algorithmic output 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

Not applicable. This is not an AI-assisted reading device.

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

Not applicable. This is a physical implant, not an algorithm.

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

Not applicable. Ground truth in the context of AI/ML is not relevant here. The ground for device "performance" is compliance with mechanical standards (ISO 14801 for fatigue testing).

8. The sample size for the training set

Not applicable. No training set for an AI/ML model.

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

Not applicable. No training set for an AI/ML model.

Conclusion:

The provided document is a conventional 510(k) premarket notification summary for a dental implant system. It demonstrates substantial equivalence to a predicate device, focusing on intended use, technological characteristics, and material safety. It does not involve any artificial intelligence or machine learning components, and therefore, the requested information pertaining to AI/ML device acceptance criteria and studies (like test sets, ground truth, experts, and comparative effectiveness) is not present and not applicable to this submission. The only "test" mentioned is non-clinical fatigue testing to an ISO standard.

Summary

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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.

Submitter:

Dong Guk Ha MegaGenImplant Co., Ltd. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si Gyeongbuk, South Korea Phone: 82-53-857-5770 Fax: 82-53-857-5432

Device Information:

Device Name: AnyOne™ Internal Implant System Classification Name: Implant, Endosseous, Root-Form Common Nmae: Endosseous Dental Implant Classification: Class II Product Code: DZE Subsequent Product Code: NHA Regulation number: 21 CFR 872.3640 Date Prepared: 1 1/20/2012

Contact /US agent: April Lee

KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Phone: 714-525-0114 Fax: 714-525-0116

AUG 15 2013

General Description

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Burn-out Cylinder, Octa Abutment, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder, Plastic Cylinder, Flat Abutment, Ball Abutment, Meg-Rhein, ZrGEN Abutment, Multi-unit Abutment, Fuse Abutment, Flat CCM Cylinder, Flat Cover Screw, Flat Healing Abutment, Flat EZ Post Cylinder, Flat Temporary Cylinder, Flat Plastic Cylinder, and Flat Gold Cylinder. The fixtures, prosthetics, and surgical instruments are produced, and packaged separately. All included

devices in the system are covered by this submission.

Indication for use

Predicate devices

XPEED AnyRidge Internal Implant System (K122231) .

Substantial Equivalence Comparison

The AnyOne™ Internal Implant System has a substantially equivalent intended use as the identified predicate. The AnyOne™ Internal Implant System 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 device are similar in size and materials.

There is no difference between the subject device and the predicate with respect to indications and technology.

	Subject Device	Predicate Device
510(k) Number	Not available yet	K122231
Device Name	AnyOne™Internal ImplantSystem	XpeedAnyRige Internal ImplantSystem
Manufacturer	MegaGen Implant Co., Ltd	MegaGen Implant Co., Ltd
Indications for Use	Mandible and Maxilla EndosseousDental Implant & Accessories	Mandible and MaxillaEndosseous Dental Implant &Accessories

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Design	AnyOne™ Internal ImplantSystem, abutments and accessorieshave been designed, manufacturedand tested in compliance withFDA's Class II special controlsguidance document root-formendosseous dental implants andendosseous dental implantabutmentsInternal Hex	XpeedAnyRidge InternalImplant System, abutments andaccessories have been designed,manufactured and tested incompliance with FDA's Class IIspecial controls guidancedocument root-form endosseousdental implants and endosseousdental implant abutmentsInternal Hex
Material	CP4 Titanium and Ti-6Al-4V-ELI	CP4 Titanium and Ti-6Al-4V-ELI
Sterilization	Gamma sterilization	Gamma sterilization
Fixture Diameter	Internal type3.9, 4.3, 4.8, 5.3, 6.3, 7.3mm(for normal thread)4.8, 5.8, 6.8, 7.8, 8.3mm(for deep thread)4.8, 5.3, 6.3, 7.3mm(for special length)	Internal type4.0, 4.4, 4.9, 5.4, 5.9mm(For normal ridge)6.4, 6.9, 7.4, 7.9, 8.4mm(For low ridge)
Fixture Height	Internal type7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm(for normal and deep thread)7.0mm(for special length)	Internal type7.7, 9.2, 10.7, 12.2,14.20, 17.2mm(For normal ridge)7.9, 9.4, 10.9, 12.4, 14.4mm(For low ridge)
Abutment	Diameters	Ø 3.8 - 10.0mm	Ø 4.0 - 10.0 mm
	Lengths	7.7 - 18.7mm	8.4 - 16.4 mm
Angulations of Angledabutments	15, 25°	15, 25°
Product Code	DZE, NHA	DZE, NHA
Surface treatment	SLA	SLA

Non-Clinical Test Data

The fatigue testing was performed in accordance with ISO 14801 standard.

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 concludes that the AnyOne™ Internal Implant system is safe and effective and substantially equivalent to predicate devices as described herein.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the figure. The figure is black, and the text is also black.

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

August 15. 2013

MegaGen Implant Company, Limited C/O Ms. April Lee KoDent, Incorporated 325 North Puente Street, Unit B BREA CA 92821

Re: K123988

Trade/Device Name: AnvOne™ Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 8. 2013 Received: August 12, 2013

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 fiability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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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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 devicerelated 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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division 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

K123988 510(K) Number (if known):

Device Name: AnyOne™ Internal Implant System

Indications for Use:

AND/OR OverThe-Counter Use Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(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 2013.08.15 09:17:05 -04'00

for M. Susan Runner, DDS, MA

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesi Devices Division of Anesthoolorology. Devices

510(k) Number:

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.