Anker Dental Implant System 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, and to restore the patient's chewing function. It is intended for delayed loading.

Device Description

Anker Dental Implant System consists of fixture, abutment (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment, temporary abutment) and cover screw. Fixture is made of pure titanium (grade IV) and its surface was treated by SLA (Sand-blasted, Large grit, Acid-etched) process. Diameters of fixtures are including 3.4 to 5.0 mm and lengthes are including 7.0 to 15.0 mm. Most abutments are made of titanium alloy and their diameters are including 4.0 to 7.0 mm. Temporary abutment is made of SUS316 stainless steel instead of titanium alloy. All products are sterilized as finished products.

AI/ML Overview

The Anker Dental Implant System is a medical device and its acceptance criteria are based on non-clinical testing to demonstrate substantial equivalence to predicate devices. No clinical study or human-in-the-loop performance study has been conducted for this device.

Here's a breakdown of the requested information:

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

Testing Item	Acceptance Criteria (Reference Standard)	Reported Device Performance
Compressive forces and Fatigue tests	ISO14801	Met ISO14801 standards (implied by "support the decision of safety and effectiveness" and "results...demonstrate...substantially equivalent")
Compatibility test of dental implant/abutmentinterface	N/A (No specific reference provided, but likely industry standards)	Met compatibility requirements (implied by "support the decision of safety and effectiveness")
Corrosion test	ASTM G3-89	Met ASTM G3-89 standards (implied by "support the decision of safety and effectiveness")
Residual of Acidic Substances Test	ISO10993-12	Met ISO10993-12 standards (implied by "support the decision of safety and effectiveness")
Biocompatibility test	ISO10993-3, ISO10993-5, ISO10993-6, ISO10993-10, ISO10993-11, Pharmacopeia US, OECD guideline #473, OECD guideline #474	Met all listed biocompatibility standards (implied by "support the decision of safety and effectiveness")
Sterilization Validation of Gamma Irradiation	ISO11137-1	Met ISO11137-1 standards (implied by "support the decision of safety and effectiveness")
Shelf life Validation	ASTM F88/F88M-09, ASTM F1140-07, ASTM F1929-98, ISO11737-2	Met all listed shelf life validation standards (implied by "support the decision of safety and effectiveness")

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

This information is not provided in the given text. The text states that "Non-clinical test was used to support the decision of safety and effectiveness," but does not specify sample sizes for these tests or the data provenance. These are laboratory/benchtop tests, not human subject studies.

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)

This information is not applicable as the acceptance criteria were established through non-clinical laboratory testing, not human expert evaluations.

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

This information is not applicable as the acceptance criteria were established through non-clinical laboratory testing.

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, an MRMC comparative effectiveness study was not conducted. The document explicitly states "Non-clinical test was used to support the decision of safety and effectiveness" and "Clinical Testing: Non-clinical test was used to support the decision of safety and effectiveness," indicating that no clinical studies with human participants were performed. This device is not an AI-assisted diagnostic tool, so comparison with human readers is not relevant.

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

No, a standalone algorithm-only performance study was not done as this device is a physical dental implant system, not a software algorithm. The "standalone" concept applies to AI/software performance in isolation, which is not applicable here.

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

The "ground truth" for the non-clinical tests was based on internationally recognized testing standards (e.g., ISO, ASTM, OECD guidelines). The device's performance was compared against the requirements and specifications outlined in these standards.

8. The sample size for the training set

This information is not applicable as there was no training set for an algorithm. The evidence presented is for a physical medical device and its material and mechanical properties.

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

This information is not applicable as there was no training set for an algorithm.

Summary

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510(k) SUMMARY

Anker Dental Implant system

Company Name: Alliance Global Technology Co., Ltd. 2F., No.92, Luke 5th Rd., Luzhu Dist., Kaohsiung City 821, Taiwan (R.O.C.) Telephone: +886-7-695-6688 Fax: +886-7-695-5329

Contact Person: Ms. Yayuan Chang Telephone: +886-7-695-6688 Fax: +886-7-695-5329 E-mail: ketty@anchorfast.com.tw

Date prepared: Sep 12nd, 2013

Trade Name: Anker Dental Implant System

Common Name: Dental Implant

Classification Name: Root-form endosseous dental implant

Device Classification: Class II

Regulation Number: 21 CFR 872.3640

Panel: Dental

Product Code: DZE

Predicate Device:

(1)Predicate Device Name: Dentium Co., Ltd Implantium Manufacturer: Dentium Company Limited 510(k) Number: K041368 (2)Predicate Device Name: Osstem GS-III system Manufacturer: OSSTEM Implant Co., Ltd.

510(k) Number: K091208

510(k) K131165-Anker Dental Implant System Section 5 - Page 5-1

NOV 14 2019

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Device Description:

Indications for Use:

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Substantial Equivalence:

Item		Anker Dental ImplantSystem	Osstem GS-III system	Dentium Co., LtdImplantium
1.	Classification	Class II	Class II	Class II
2.	Code orFederalRegulations	872.3640	872.3640	872.3640
3.	510K No.	K131165	K091208	K041368
4.	Design	Image: Anker Dental Implant	Image: Osstem GS-III system	Image: Dentium Co., Ltd Implantium
5.	Intended Use	Anker Dental ImplantSystem is intended to besurgically placed in the boneof the upper or lower jawarches to provide support forprosthetic devices, such asartificial teeth, and to restorethe patient's chewingfunction. It is intended fordelayed loading.	The GS III System isindicated for use inpartially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework. The GS IIISystem is for single andtwo stage surgicalprocedures. It is not forimmediate load.	The Dentium Co., LtdImplantium is intended tobe surgically placed in thebone of the upper orlower jaw arches toprovide support forprosthetic devices, suchas artificial teeth, and torestore the patient'schewing function.
6.	BodyDiameter	3.4mm, 3.5mm, 3.8mm,4.0mm, 4.3mm, 4.5mm,4.8mm, 5.0mm	3.7 mm,4.2 mm,4.6 mm,5.1mm	3.4mm, 3.8mm, 4.3mm,4.8mm
7.	Length	7mm, 8 mm, 8.5mm, 10mm,11.5mm, 12mm, 13mm,14mm,15mm	7 mm, 8.5 mm, 10mm,11.5 mm, 13mm, 15mm	8 mm, 10 mm, 12mm,14mm
8.	Surface	S.L.A. (Sand-blasted, Largegrit, Acid-etched surface)	RBM (ResorbableBlasting Media)	S.L.A. (Sandblasting withlarge grit and acidetching)
9.	Sterilization	y-ray (Radiation)	y-ray (Radiation)	y-ray (Radiation)
10.	Material	Titanium	Titanium	Titanium
11.	Abutmentangulations	0. 17 deg	0. 17 deg	0. 15, 25 deg
12.	Material ofAbutments	Titanium Vanadium Alloy	Titanium Vanadium Alloy	Titanium Vanadium Alloy

510(k) K131165-Anker Dental Implant System Section 5 - Page 5-3

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Comparing to the predicate devices, Dentium Co., Ltd Implantium (510K No. K041368) and Osstem GS-III system (510K No. K091208), Anker Dental Implant System is equivalent in surface treatment, intended use, method of operation, material and design.

Non-clinical Testing:

Non-clinical test was used to support the decision of safety and effectiveness.

Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the Anker Dental Implant System is substantially equivalent to the predicate devices.

Testing Item	Reference
Compressive forces and Fatigue tests	ISO14801
Compatibility test of dental implant/abutmentinterface	N/A
Corrosion test	ASTM G3-89
Residual of Acidic Substances Test	ISO10993-12
Biocompatibility test	ISO10993-3ISO10993-5ISO10993-6ISO10993-10ISO10993-11Pharmacopeia USOECD guideline #473

Overview for all non-clinical testing:

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	OECD guideline #474
Sterilization Validation of Gamma Irradiation	ISO11137-1
Shelf life Validation	ASTM F88/F88M-09
	ASTM F1140-07
	ASTM F1929-98
	ISO11737-2

Clinical Testing:

Non-clinical test was used to support the decision of safety and effectiveness.

Conclusion:

The evaluation of the Anker Dental Implant system does not raise any additional . concerns regarding safety and effectiveness and Anker Dental Implant system may therefore be considered substantially equivalent to their predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

November 14, 2013

Alliance Global Company Technology Company, Limited Ms. Yayuan Chang Manager 2F., No.92, Luke 5th Road Luzhu District, Kaohsiung City 82151 TAIWAN (R.O.C.)

Re: K131165

Trade/Device Name: Anker Dental Implant System Regulation Number: 21 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 4, 2013 Received: October 7, 2013

Dear Ms. Chang:

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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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,

MaryFDAmer-S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K131165

Device Name: Anker dental implant system

Indications for Use:

Prescription Use ____________ Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (2) 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 I of ____________________________________________________________________________________________________________________________________________________________________

510(k) K131165-Anker Dental Implant System Section 4 - Page 4-1

Andrew I. Steen -S - . - . 2013.11.13 11:25:52 -05'00'

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.