Anker Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Anker Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

Specific indications for small diameter (Ø 3.3mm) and short (length < 7mm) dental implants:

Because of their reduced mechanical stability, small diameter and short implants are only used in cases with a low mechanical load. We recommend only used in the mandibular anterior region and maxillary lateral incisor.

Device Description

Anker Dental Implant System is an integrated system which includes Bone Level (SB-III series) and Tissue Level (ST and AT series) dental implants.

Anker Dental Implant System SB-III series consists of fixture, abutments (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment, temporary abutment, convertible abutment, convertible protect cap, convertible combination cylinder, convertible angled cylinder, convertible temporary cylinder, angled screw abutment, temporary cylinder) and cover screw.

Anker Dental Implant System ST and AT series consist of fixture, abutments (healing cap, solid abutment, cementable abutment, angled abutment, temporary restoration screw, screw retained abutment, locator abutment) and closure screw.

Fixtures are made of pure titanium (grade IV) and there surface was treated by SLA (Sand-blasted, Large grit. Acid-etched) process. Diameters of fixtures are including 3.3 to 5.0 mm and lengthes are including 7.0 to 15.0 mm. Cover screw, closure screw and most abutments are made of titanium alloy. Temporary abutment and convertible temporary cylinder (SB-III series) are made of SUS316L stainless steel instead of titanium alloy. All products are sterilized as finished products.

AI/ML Overview

The provided text is a 510(k) summary for the Anker Dental Implant System, a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way a novel AI/software medical device might.

Therefore, the information requested in your prompt (especially points 1-7, and 9 for a training set) is not directly applicable to this document. This submission does not describe an AI/software device with performance metrics like sensitivity, specificity, or reader improvement. It describes a physical dental implant system and relies on non-clinical testing to demonstrate that it meets established safety and performance standards by being similar to already approved devices.

Here's a breakdown of what can be extracted and why other parts cannot, based on the provided text:

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

Not applicable in the AI/software sense. This document does not define quantitative performance metrics like accuracy, sensitivity, or specificity with specific acceptance thresholds for the dental implant system as a whole in the way an AI diagnostic tool would.
Instead, acceptance is demonstrated by meeting harmonized standards for mechanical and biocompatibility testing. The "reported device performance" is that it passed these tests. The table on page 8 lists the testing items and standards referenced, implying that meeting these standards is the "acceptance criteria" for those specific aspects.
- Compressive forces and fatigue tests: ISO14801 (Likely relates to mechanical strength and durability under chewing forces)
- Compatibility test of dental implant/abutment interface: N/A (Indicates no specific standard, but testing was performed)
- Corrosion test: ASTM G3-89
- Residual of Acidic Substances Test: ISO10993-12 (Biocompatibility, specifically related to the SLA surface treatment)
- Biocompatibility tests: ISO10993-3, ISO10993-5, ISO10993-6, ISO10993-10, ISO10993-11, Pharmacopeia US, OECD guideline #473, OECD guideline #474 (Cover various aspects like genotoxicity, cytotoxicity, irritation, sensitization, systemic toxicity)
- Sterilization validation of GAMMA irradiation: ISO11137-1
- Shelf life Validation: ASTM F88/F88M-09, ASTM F1140-07, ASTM F1929-98, ISO11737-2 (Relates to package integrity and sterility maintenance over time)

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

Not applicable in the AI/software sense. There isn't a "test set" of patient data in the context of an AI algorithm. The testing involves physical samples of the dental implants. The document does not specify the number of individual implant units tested for each non-clinical test (e.g., how many implants were subjected to fatigue testing).
Data provenance: The tests are likely performed by the manufacturer or accredited labs compliant with the referenced standards. The manufacturer is Alliance Global Technology Co., Ltd. from Taiwan.

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

Not applicable. There is no "ground truth" establishment by experts in this context as would be done for an AI diagnostic algorithm. The "ground truth" for these physical tests is adherence to the scientific principles and methodologies outlined in the referenced ISO and ASTM standards.

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

Not applicable. This concept relates to expert review of medical images or data for AI algorithm validation. For physical device testing, adherence to a standard's protocol and acceptance criteria is the assessment method.

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, not an AI software. No human reader study with or without AI assistance was performed.

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

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

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

Not applicable in the typical AI sense. For this device, the "ground truth" is defined by the technical specifications and performance requirements derived from harmonized standards (e.g., ISO for mechanical properties, ASTM for corrosion, ISO 10993 for biocompatibility). Passing these tests constitutes meeting the "ground truth" of safety and performance for a dental implant.

8. The sample size for the training set:

Not applicable. This device does not use a "training set" as it's not an AI/machine learning model.

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

Not applicable.

In summary: The provided document is a 510(k) submission for a physical medical device (dental implants), not an AI/software medical device. Therefore, the questions related to AI/software performance metrics, ground truth establishment by experts, and training/test set methodologies are not relevant and cannot be answered from this text. The "study" that proves the device meets "acceptance criteria" here refers to the non-clinical testing performed according to recognized international standards, demonstrating equivalence to predicate devices.

Summary

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

September 21,2015

Alliance Global Technology Co., Ltd. Yayuan Chang 2F., No.92, Luke 5th Rd., Luzhu Dist., Kaohsiung City 82151. Taiwan

Re: K142557

Trade/Device Name: Anker Dental Implant System - SB-III, ST and AT Series Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 21, 2015 Received: August 25, 2015

Dear Yayuan 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.

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

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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 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,

Susan Runno DDS, MA

Erin Keith 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 Alliance Global Technology Co., LTD. The logo features the word "ALLIANCE" in large, bold, green letters. Above the word "ALLIANCE" is a green globe. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD." in smaller, black letters.

Indications for Use

510(k) Number: K142557

Device Name: Anker Dental Implant System - SB-III, ST and AT series

Indications for Use:

Specific indications for small diameter ( $ 3.3mm) and short (length < 7mm) dental implants:

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

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Image /page/3/Picture/0 description: The image shows the logo for Alliance Global Technology Co., LTD. The logo features a green globe above the word "ALLIANCE" in large, green, bold letters. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD." in smaller, black letters.

K142557 510(k) SUMMARY

Anker Dental Implant System – SB-III, ST and AT series

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

1. Contact Person: Ms. Yayuan Chang E-mail: ketty@anchorfast.com.tw
1. Date prepared: Sep. 5th, 2014
1. Trade Name: Anker Dental Implant System SB-III, ST and AT series Common Name: Dental Implant Classification Name: Root-form endosseous dental implant
1. Device Classification: Class II
1. Regulation Number: 21 CFR 872.3640 Panel: Dental Product Code: DZE

7. Predicate Devices:

K131165	Anker Dental Implant System (Primary Predicate for proposed fixtures SB-III, ST, and proposed abutments SB-III)
K123784	Straumann Dental Implant System SLA & SLActive & Roxolid Product Families (Reference Predicate for proposed fixture AT, ST)
K130808	Straumann healing abutments, healing caps, closure screws (Reference Predicate for proposed abutments of ST and AT)
K120822	Straumann CARES Variobase Abutments (Reference Predicate for proposed abutments of ST and AT)
K121585	Osstem TS Implant System (Reference Predicate for proposed abutment SB-III)
K052957	Dentium Implantium Prosthetics (Reference Predicate for proposed abutment SB-III)

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Image /page/4/Picture/0 description: The image shows the logo for Alliance Global Technology Co., LTD. The logo features a green globe with the company name in large, bold, green letters below it. Underneath the company name, the words "GLOBAL TECHNOLOGY CO., LTD." are written in smaller letters.

8. Device Description:

Anker Dental Implant System is an integrated system which includes Bone Level (SB-III series) and Tissue Level (ST and AT series) dental implants.

Anker Dental Implant System SB-III series consists of fixture, abutments (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment,

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Image /page/5/Picture/0 description: The image shows the logo for Alliance Global Technology Co., LTD. The logo features a green globe above the word "ALLIANCE" in large, green, bold letters. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD." in smaller, black letters.

temporary abutment, convertible abutment, convertible protect cap, convertible combination cylinder, convertible angled cylinder, convertible temporary cylinder, angled screw abutment, temporary cylinder) and cover screw.

Fixture of Anker Dental Implant System SB-III series is substantially equivalent in design, function and intended use to the Anker Dental Implant System (K131165). Fixture of AT series is substantially equivalent in design, function and intended use to the Straumann Dental Implant System (K123784). And fixture of ST series is substantially equivalent in design, function and intended use to the Anker Dental Implant System (K131165) and Straumann Dental Implant System (K123784).

Abutment of Anker Dental Implant System SB-III series is substantially equivalent in design, function and intended use to the Anker Dental Implant System (K131165), TS Implant System (K121585) of Osstem Implant Co., Ltd. and Implantium Prosthetics (K052957) of Dentium Co., Ltd. Abutment of ST and AT series are substantially equivalent in design, function and intended use to the Straumann healing abutments, healing caps, closure screws (K130808) and Straumann CARES Variobase Abutments (K120822).

9. Indications for Use:

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Image /page/6/Picture/0 description: The image shows the logo for Alliance Global Technology Co., LTD. The logo features a green globe above the word "ALLIANCE" in large, green, bold letters. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD." in a smaller font size.

Specific indications for small diameter (Ø3.3mm) and short (length < 7mm) dental implants:

10. Substantial Equivalence:

The following tables list the proposed devices Anker Dental Implant System – SB-III, ST and AT series and the respective predicate which Anker is claiming substantial equivalence to.

	Item	Anker Dental Implant SystemSB-III, ST and AT series	Anker Dental Implant System	Straumann Dental ImplantSystem SLA, SLActive andRoxolid Product Families
1	510K No.		K131165	K123784
2	Design	Image: SB-IIIImage: STImage: AT-IImage: AT-IIImage: AT-III	Image: Anker Dental Implant System	Image: Straumann Dental Implant System
3	Intended Use	Anker Dental Implant System isintended to be surgically placed inthe alveolar bone of upper orlower jaw arches to providesupport for prosthetic devices,such as artificial teeth, and torestore the patient's chewingfunction. Anker Dental ImplantSystem is intended for delayedloading. No matter placingimplants in anterior or posteriorregion, we recommend choosingthe diameter of implants as largeas possible. The prostheticrestorations used are singlecrowns, bridges and partial orfull dentures, which areconnected to the implantsthrough the correspondingcomponents (abutments).Specific indications for smalldiameter ( $Ø$ 3.3mm) and short(length < 7mm) dental implants:	Anker Dental Implant System isintended to be surgically placedin the bone of the upper or lowerjaw arches to provide support forprosthetic devices, such asartificial teeth, and to restore thepatient's chewing function.	Straumann® Dental implantsare indicated for oral endostealimplantation in the upper andlower jaw arches for thefunctional and aesthetic oralrehabilitation of edentulous andpartially dentate patients.Straumann® Dental implantsare also indicated for immediateor early implantation followingextraction or loss of naturalteeth. Implants can be placedwith immediate function onsingle-tooth and/or multipletooth applications when goodprimary stability is achieved andwith appropriate occlusalloading to restore chewingfunction. The prostheticrestorations used are singlecrowns, bridges and partial orfull dentures, which areconnected to the implants

		Because of their reducedmechanical stability, smalldiameter and short implants areonly used in cases with a lowmechanical load. Werecommend only used in themandibular anterior region andmaxillary lateral incisor.		through the correspondingcomponents (abutments). Incases of fully edentulouspatients, 4 or more implantsmust be used in immediatelyloaded cases.
4	Material	Titanium	Titanium	Titanium
5	BodyDiameter	SB-III and ST series:3.5mm, 4.0mm, 4.5mm, 5.0mmAT series:3.3mm, 4.1mm, 4.8mm	3.4mm, 3.5mm, 3.8mm, 4.0mm,4.3mm, 4.5mm, 4.8mm, 5.0mm	3.3mm, 4.1mm, 4.8mm
6	Length	SB-III and ST series:7mm, 8.5mm, 10mm, 11.5mm,13mm, 15mmAT series:8mm, 9mm, 10mm, 11mm,12mm, 13mm, 14mm,15mm	7mm, 8mm, 8.5mm, 10mm,11.5mm, 12mm, 13mm, 14mm,15mm	6mm, 8mm, 10mm, 12mm,14mm, 16mm
7	Design offixture body	SB-III and ST series: tapereddesign.AT series: Straight design.	Tapered design	Straight design
8	PlatformSwitching	SB-III series: YESST & AT series: NO	YES	NO
9	Internalconnection	SB-III series: Internal hexconnection and 11°morse taperstructure.ST & AT series: Internal octaconnection and 8°morse taperstructure.	Internal hex connection and11°morse taper structure.	Internal octa connection and8°morse taper structure.
10	Threaddesign	SB-III and ST series:combined with micro thread(0.45mm pitch distance,fourfold thread) and macrothread (0.9mm pitch distance,double thread) structure.AT series: same pitch distanceon whole fixture body.	Combined with micro thread(0.45mm pitch distance,fourfold thread) and macrothread (0.9mm pitch distance,double thread) structure.	Same pitch distance on wholefixture body.
11	Apex design	SB-III and ST series: threeblade self tapping design andblunt end structure.AT series: no blade design andround end structure.	Three blade self tapping designand blunt end structure.	No blade design and round endstructure.
12	SurfaceTreatment	S.L.A. (Sand-blasted, Largegrit, Acid-etched surface)	S.L.A. (Sand-blasted, Large grit,Acid-etched surface)	S.L.A. (Sand-blasted, Large grit,Acid-etched surface) / SLActive
		Image: Sand blasted large grit acid etched surface	Image: Sand blasted large grit acid etched surface	Image: Sand blasted large grit acid etched surface
13 Sterilization	γ-ray (Radiation)	γ-ray (Radiation)	γ-ray (Radiation)
14 Material of Abutments	Titanium alloy and stainless steel	Titanium alloy and stainless steel	Titanium and titanium alloy

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Image /page/8/Picture/0 description: The image shows the logo for Alliance Global Technology Co., Ltd. The logo features a green globe in the background, with the word "ALLIANCE" in large, bold, green letters in the foreground. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD." in smaller, less bold letters.

When compared to the predicate devices. Anker Dental Implant System (K131165) and Straumann Dental Implant System (K123784), Anker Dental Implant System SB-III, ST and AT series are equivalent in surface treatment, intended use, method of operation, material and design.

11. Non-clinical Testing:

Overview all non-clinical testing:

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

Non-clinical test was used to support the decision of substantial equivalence. 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 - SB-III, ST and AT series are substantially equivalent to the predicate devices.

12. Clinical Testing:

No clinical studies are submitted.

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Image /page/9/Picture/0 description: The image shows the logo for Alliance Global Technology Co., LTD. The logo features a green globe above the word "ALLIANCE" in large, green letters. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD." in smaller letters.

13. Conclusion:

The evaluation of the Anker Dental Implant System – SB-III, ST and AT series do not raise any additional concerns regarding substantial equivalence and Anker Dental Implant System – SB-III, ST and AT series may therefore be considered substantially equivalent to their predicate device.

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.