The Ti Star Implant System is intended to be 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.

The Ti Star Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

The Ti Star Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Ti Star Implant System consist of one-stage and two-stage, root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options. The devices covered by this submission are Ti Star Implant Fixtures, abutments, cover screw, closing screw and healing screw. The diameters of implant fixture are 3.5mm, 4.1mm and 4.8mm, the lengths are 7.0mm, 8.5mm, 10.0mm, 11.5mm, 13.0mm and 15.0mm.

AI/ML Overview

The provided 510(k) summary for the Ti Star Implant System is for a dental implant, which is a physical device, not an AI/ML powered SaMD (Software as a Medical Device). Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set sample size, etc.) are not applicable here.

However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria, based on the document provided.

1. Table of Acceptance Criteria and Reported Device Performance

For the Ti Star Implant System, the acceptance criteria are based on compliance with established international and ASTM standards for dental implants. The performance is reported as meeting these requirements.

Test Item	Standard and Regulations Applied	Acceptance Criteria Met (Reported Device Performance)
Biomechanical Testing	ISO 14801:2007 Dentistry. Implants. Dynamic fatigue test for endosseous dental implants	Met requirements
Sterilization	ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on productsISO 11737-2:2009 Sterilization of medical devices - Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processISO 11137-2:2012 Sterilization of health care products – Radiation - Part 2: Establishing the sterilization doseISO 17665-1:2006 Sterilization of health care products – Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. (Sterility)ISO 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1. (Sterility)	Met requirements
Surface and Material	ASTM E3 - 11 Standard Guide for Preparation of Metallographic SpecimensASTM F746-04 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials. (Materials)ISO 16700 Microbeam analysis -- Scanning electron microscopy -- Guidelines for calibrating image magnificationASTM F67-06, Standard Specification for Unalloyed Titanium for Surgical Implant ApplicationsASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).ASTM F1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages. (Sterility)ASTM F1929-98(04) Standard test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye PenetrationASTM F88 2007 Standard Test Method for Seal Strength of Flexible Barrier MaterialsASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical DevicesASTM F88/F88M 2009 Standard Test Method for Seal Strength of Flexible Barrier Materials	Met requirements

The document states: "All the test results demonstrate Ti Star Implant System meets the requirements of its pre-defined acceptance criteria and intended uses."

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 as the tests are non-clinical (bench testing). The document does not specify the exact number of units or batches tested for each standard, nor the country of origin of the test data.

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. This is a non-clinical device that was evaluated through physical and material testing against international standards, not through human expert review of clinical data.

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

Not applicable, as this is related to human interpretation of data for AI/ML performance.

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 medical device, not an AI/ML system, and no human reader studies are mentioned.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device is the established performance requirements defined by the international and ASTM standards (e.g., ISO 14801 for dynamic fatigue, ISO 11737 for sterilization, ASTM F746 for corrosion). The device performance was compared against these technical specifications.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML system.

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

Not applicable. This is a physical medical device.

Summary

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K829qz

DEC 18 2013

T-PLUS Implant Tech. Co., Ltd. 510(k) Notification

Ti Star Implant System

510(k) Summary

5.1	Type of Submission:	Traditional
5.2	Preparation Date:	12th September 2013
5.3	Submitter:	T-PLUS Implant Tech. Co., Ltd.
Address:	No.41, Wuquan 6th Rd. Wugu Dist., New Taipei City Taiwan, (R.O.C.)
Phone:	886-2-22981950
Fax:	886-2-22984353
Contact:	Dana Cheng (tplus.dana@gmail.com)
5.4	Identification of the Device:
Proprietary/Trade name:	Ti Star Implant System
Classification Name:	Endosseous Dental Implant System
Device Classification:	II
Regulation Number:	872.3640
Panel:	Dental
Product Code:	DZE, NHA

5.5	Identification of the Predicate Device:
Predicate Device Name:	ExFeel Implant System

Predicate Device Name:	ExFeel Implant System
Manufacturer:	MegaGen Co., Ltd.
Product Code:	DZE
510(k) Number:	K052369

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T-PLUS Implant Tech. Co., Ltd. 510(k) Notification

5.6 Intended Use and Indications for Use of the subject device.

The Ti Star Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

5.7 Device Description

5.8 Non-clinical Testing

A series of safety tests were performed to assess the safety and effectiveness of the Ti-Star Implant Systems.

Testing Item	Standard and regulations applied
Biomechanicaltesting	ISO 14801:2007 Dentistry. Implants. Dynamic fatiguetest for endosseous dental implants
Sterilization	ISO 11737-1:2006 Sterilization of medical devices -Microbiological methods - Part 1: Determination of apopulation of microorganisms on productsISO 11737-2:2009 Sterilization of medical devices -Microbiological methods – Part 2: Tests of sterilityperformed in the definition, validation and maintenanceof a sterilization process
	ISO 11137-2:2012 Sterilization of health care products –
	Radiation - Part 2: Establishing the sterilization dose
	ISO 17665-1:2006 Sterilization of health care products –
	Moist heat -- Part 1: Requirements for the development,
	validation, and routine control of a sterilization process
	for medical devices. (Sterility)
	ISO 17665-2:2009 Sterilization of health care products -
	Moist heat - Part 2: Guidance on the application of ISO
	17665-1. (Sterility)
Surface and material	ASTM E3 - 11 Standard Guide for Preparation of
	Metallographic Specimens
	ASTM F746-04 Standard Test Method for Pitting or
	Crevice Corrosion of Metallic Surgical Implant Materials.
	(Materials)
	ISO 16700 Microbeam analysis -- Scanning electron
	microscopy -- Guidelines for calibrating image
	magnification
	ASTM F67-06, Standard Specification for Unalloyed
	Titanium for Surgical Implant Applications
	ASTM F136 Standard Specification for Wrought
	Titanium-6 Aluminum-4 Vanadium ELI (Extra Low
	Interstitial) Alloy for Surgical Implant Applications (UNS
	R56401).
	ASTM F1140-07 Standard Test Methods for Internal
	Pressurization Failure Resistance of Unrestrained
	Packages. (Sterility)
	ASTM F1929-98(04) Standard test Method for Detecting
	Seal Leaks in Porous Medical Packaging by Dye
	Penetration
	ASTM F88 2007 Standard Test Method for Seal Strength
	of Flexible Barrier Materials
	ASTM F1980-07 Standard Guide for Accelerated Aging
of Sterile Barrier Systems for Medical Devices
ASTM F88/F88M 2009 Standard Test Method for Seal
Strength of Flexible Barrier Materials

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T-PLUS Implant Tech. Co.. Ltd.
510(k) Notification

· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

:: ::

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T-PLUS Implant Tech. Co., Ltd. 510(k) Notification

All the test results demonstrate Ti Star Implant System meets the requirements of its pre-defined acceptance criteria and intended uses.

5.9 Clinical Testing

No clinical test data was used to support the decision of safety and effectiveness.

5.10 EMC and Electrical safety

The devices do not require EMC/Electrical Safety evaluation.

5.11 Substantial Equivalence Determination

The Ti Star Implant Systems submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared ExFeel Implant System (K052369). Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

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T-PLUS Implant Tech. Co., Ltd. 510(k) Notification

。

	Proposed Device	Predicate Device
	Ti Star Implant System	ExFeel Implant System(K052369)
Item
Classification	Class II	Class II
Product Code	DZE 、NHA	DZE
Intended Use	The Ti Star Implant System isintended to be placed in theupper or lower jaw to supportprosthetic devices, such asartificial teeth, and to restorea patient's chewing function.This may be accomplishedusing either a two stagesurgical procedure or a singlestage surgical procedure.The Ti Star Implant System isintended for use forimmediate loading whengood primary stability isachieved and with appropriateocclusal loading	The ExFeel DentalImplant Systems areintended to be placed inthe upper or lower jaw tosupport prosthetic devices,such as artificial teeth, andto restore a patient'schewing function. Thismay be accomplishedusing either a two stagesurgical procedure or asingle stage surgicalprocedure
Consisted Instruments	1. Fixture2. Various abutments andcomponents	1. Fixture2. Various abutmentsand components
Material	C.P Titanium and TitaniumAlloy	C.P Titanium andTitanium Alloy
Implant type	Threaded, screw type,root-form, fixation, tapered,internal and morse taper	Internal, External Hex andMorse Taper
Implant to abutmentconnection	Internal Octa Connection	Internal Octa Connection

・

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T-PLUS Implant Tech. Co., Ltd. 510(k) Notification

Implant surface treatment		RBM	RBM
Dimensions	Diameter	3.5、4.1、4.8	3.5、4.1、4.8
(mm)	Length	7.0、8.5、10.0、11.5、13.0、15.0	7.0、8.5、10.0、11.5、13.0、15.0
Sterilization		Gamma irradiation	Gamma irradiation
Design/technical characteristics of the abutment
Abutment material		Gr.4、Gr.5	Gr.3、Ti6AlV、ELI Gr.23、SUS316L
Collar heights (mm)		2.2	2.2
Abutment System		Multi-mount、Solid、SolidPost、Ez Post	Multi-mount、Octa、Solid、Ez Post、Esthetic,Mirus, Widecone、Standard
Abutment angle		--	--

Similarity and differences 5.11

The only difference between the subject device and predicate device is on the grade of C.P Titanium and Titanium Alloy. The predicate devices were Gr.3, Ti6AlV, ELI Gr.23 and SUS316L. The materials of subject device were Gr.4 and Gr.5. The subject device has tested on safety and performance tests and the test results were complied with the test requests. Therefore, the difference of subject device and predicate device didn't raise any problems of safety or effectiveness. The proposed device is substantially equivalent to the predicate device in design, operation, intended use, method of preparation, and performance claims.

5.12 Conclusion

After analyzing bench tests, safety testing data, it can be concluded that Ti Star Implant System is as safe and effective as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three curved lines representing snakes or streams.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

December 18, 2013

T-PLUS Implant Tech Company, Limited Ms. Dana Cheng Quality Assurance No. 41, Wuquan 6th Rd. Wugu Dist., New Taipei City TAIWAN

Re: K132992

Trade/Device Name: Ti Star Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant System Regulatory Class: II Product Code: DZE Dated: November 28, 2013 Received: November 29, 2013

Dear Ms. Cheng:

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. Cheng

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/ReportalProblem/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 vours.

Image /page/7/Picture/7 description: The image shows the name "Kwame O. Ulmer-S" in bold, black font. The text is arranged in two lines, with "Kwame O." on the first line and "Ulmer-S" on the second line. The background is white, and there is some noise or artifacts around the text, particularly on the right side of the image.

for

Erin I. Keith, M.S. 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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T-PLUS Implant Tech. Co., Ltd. 510(k) Notification

1000, 800

Ti Star Implant System

Indications for Use

510(k) Number (if known):

Ti Star Implant System Device Name: Indications for Use: K 32992

The Ti Star Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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

Over-The-Counter Use_ (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)

Elizabeth F. Claverie -S 2013.12.19 16:41:40 -05'00'

Page 1 of _

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.