SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Device Description

Customized 3D Pre-Formed Titanium Membrane. SMARTBuilder is the non-absorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity. The SMARTbuilder is made of pure titanium metal and supplied sterile. The SMARTbuilder system is used with GS3 System (K091208) of OSSTEM Implant Co., Ltd. and US.SS.GS System (K073247) of OSSTEM Implant Co., Ltd.

AI/ML Overview

The provided 510(k) summary for the OSSTEM Implant Co., Ltd. SMARTbuilder System indicates that it is a substantially equivalent device, not a new device requiring extensive performance studies with acceptance criteria. Therefore, the document does not describe acceptance criteria or a study that proves the device meets such criteria in the way a novel medical device would.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Neo Titanium mesh, CTi-mem, K111761, and SQ IS SYSTEM, K090825). This is a common regulatory pathway for devices that have similar intended use, design, and materials to devices already on the market.

Here's an analysis of the provided information in the context of your request:

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

No explicit acceptance criteria or reported device performance are provided in the traditional sense of a clinical or analytical study with defined endpoints/thresholds.
The document presents "Substantial Equivalence Matrix" tables, comparing the SMARTbuilder System (and its components like Healing Abutment, Height, Cover Cap) to predicate devices on characteristics such as:
- Design
- Intended use
- Material
- Dimensions (Width, Diameter, Height)
- Sterilization
- Shelf life
The "performance" demonstrated is that these characteristics are "same" or "similar" to the predicate devices. For example:
- Material: "Pure Titanium Grade 2 (ASTM F67)" for SMARTbuilder membrane, "Pure Titanium Grade 2 (ASTM F67)" for predicate.
- Intended Use: "SMARTbuilder is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites." for SMARTbuilder, "For Stabilization and support bone grafts in dento-alveolar bony defect sites" for predicate.
- Sterilization: "Sterile" for both.
- Shelf life: "5 years" for SMARTbuilder, no information for predicate (implies it isn't a distinguishing factor for substantial equivalence).
- Width (D): SMARTbuilder offers 8, 9, 10, 12, while predicate is 12. This shows similarity with some additional options.

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. No test set or performance data from a specific study is presented. The comparison is based on the specifications of the devices themselves, not on a study with a test subject sample.

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. There was no "test set" requiring ground truth established by experts. Substantial equivalence relies on regulatory review of design, material, and intended use claims against predicate devices.

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

Not applicable. No test set or adjudication process 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

Not applicable. This device is a dental bone plate/membrane system, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this submission.

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

Not applicable. This device is not an algorithm.

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

Not applicable. There is no "ground truth" established from studies in this submission. The "truth" for substantial equivalence is based on the characteristics and regulatory status of the predicate devices.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/algorithm device.

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

Not applicable. No training set or ground truth for it is mentioned.

Summary of what the document does communicate regarding evidence for market clearance:

The submission focuses entirely on demonstrating substantial equivalence to already legally marketed predicate devices. The arguments for equivalence are based on:

Identical Intended Use: The SMARTbuilder system shares the same intended use (stabilizing and supporting bone graft in dento-alveolar bony defect sites) as the predicate devices.
Similar Design and Technological Characteristics: Dimensions are shown to be similar or within a comparable range. The overall design concept (a pre-formed titanium membrane and associated abutments/caps) is presented as similar.
Identical Materials: The core materials (Pure Titanium Grade 2, Pure Titanium Grade 4, Titanium alloy Ti 6Al 4V) are identified as the same or highly similar (ASTM F67, ASTM F136) to those used in the predicate devices.
Identical Sterilization Method: Both the proposed device and predicates are supplied sterile.
Known Biocompatibility: The submission explicitly states, "Biocompatibility evaluation for SMARTbuilder System is not considered because SMARTbuilder System, which is made with titanium alloy, has been generally and widely used as a dental material such as implant for a long time." This leverages the known safety profile of the materials.
No Clinical Studies: The submission explicitly states, "No clinical studies are submitted." This reinforces that clearance is based on substantial equivalence to existing devices, not new clinical performance data.

In essence, the "acceptance criteria" for this 510(k) was to successfully argue that the SMARTbuilder System is as safe and effective as the predicate devices based on a comparison of their fundamental characteristics, without requiring new performance studies.

Summary

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K 120951

ОСТ 3 2012 -

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.

Date: August 28, 2012

Company and Correspondent making the submission:

Submitter's Name :
Address :

OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea

Contact :

Device :

Trade or (Proprietary) Name : Classification Name :

SMARTbuilder System Bone Plate 21CFR872.4760 Class II JEY, NHA

Mr. Hee Kwon Son

Predicate Device:

The Neo Titanium mesh, CTi-mem, Neobiotech Co., Ltd., K111761 The SQ IS SYSTEM, Neobiotech Co., Ltd., K090825

4. Description:

		Dimensions (mm)
Image: BW	Image: BD and BL	BW(Buccal width): 8.0, 10.0BD(Buccal Distance): 5.5BL(Buccal Length): 7, 9

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

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Image /page/1/Figure/0 description: The image shows diagrams of dental implant components with associated measurements. The first two components have a buccal width of 9.0 to 12.0, a buccal distance of 5.5, and a buccal length of 7 to 9. Other components have height measurements ranging from 0.5 to 3.0 and diameters from 3.3 to 5.03, while another has a height of 1.52 and a diameter of 4.0.

OSSTEM Implant Co., Ltd

The SMARTbuilder is made of pure titanium metal and supplied sterile.

The SMARTbuilder system is used with GS3 System (K091208) of OSSTEM Implant Co., Ltd. and US.SS.GS System (K073247) of OSSTEM Implant Co., Ltd.

The SMARTbuilder is substantially equivalent in design, function and intended use to the Neo Titanium mesh, CTi-mem (K111761) of Neobiotech Co., Ltd Height, Healing abutment and Cover cap of The SMARTbuilder system are substantially equivalent in design, function and intended use to the SQ IS SYSTEM (K090825) of Neobiotech Co., Ltd

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

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OSSTEM® MPLANT

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea

Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

- Substantial Equivalence Matrix
	SMARTbuilder	Predicate devicesCTi-mem (K111761)
Design	Image: SMARTbuilder design	Image: Cti-mem design
Intendeduse	SMARTbuilder is a metal device intendedfor use with a dental implant to stabilize andsupport of bone graft in dento-alveolar bonydefect sites.	For Stabilization and support bone grafts indento-alveolar bony defect sites
Material ofFixture	Pure Titanium Grade 2 (ASTM F67)	Pure Titanium Grade 2 (ASTM F67)
Width (D)	8, 9, 10, 12	12
Sterilization	Sterilie	Sterilie
Shelf life	5 years
SE	The SMARTbuilder has same material and indication for use and similar design andtechnological characteristics as the predicate device, such as the CTi-mem

- Substantial Equivalence Matrix

	SMARTbuilder SystemHealing Abutment	Predicate devices
		SQ IS SYSTEM (K090825)CTi Healing Abutment
Design	Image: SMARTbuilder System Healing Abutment	Image: SQ IS SYSTEM (K090825) CTi Healing Abutment
Intendeduse	SMARTbuilder is a metal device intendedfor use with a dental implant to stabilize andsupport of bone graft in dento-alveolar bonydefect sites.	For Stabilization and support bone grafts indento-alveolar bony defect sites
Material ofFixture	Pure Titanium Grade 4 (ASTM F67)	Pure Titanium (ASTM F67)
Diameter	4.0~7	4.0
Height	3.35~4.22	3.0, 4.0
Sterilization	Sterilie	Sterilie
Shelf life	5years
SE	The Healing Abutment has same material and indication for use and similar design andtechnological characteristics as the predicate device, such as the CTi Healing Abutment

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

September 1997 - 1992 - 1992 - 1991 - 1991 - 19

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OSSTEM® IMPLANT

OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

	SMARTbuilder SystemHeight	Predicate devicesSQ IS SYSTEM (K090825)CTi Spacer
Design
Intendeduse	SMARTbuilder is a metal device intended foruse with a dental implant to stabilize andsupport of bone graft in dento-alveolar bonydefect sites.	For Stabilization and support bone grafts indento-alveolar bony defect sites
MaterialofFixture	Titanium alloy Ti 6Al 4V (ASTM F 136)	Pure Titanium (ASTM F67)
Sterilization	Sterilie	Sterilie
Shelf life	5years
SE	The Height has same material and indication for use and similar design andtechnological characteristics as the predicate device, such as the CTi Spacer

	SMARTbuilderCover Cap	Predicate devices
	Image: SMARTbuilder Cover Cap	SQ IS SYSTEM (K090825)CTi Cover Cap
Design	Image: SMARTbuilder Cover Cap	Image: CTi Cover Cap
Intendeduse	SMARTbuilder is a metal device intended foruse with a dental implant to stabilize andsupport of bone graft in dento-alveolar bonydefect sites.	For Stabilization and support bone grafts indento-alveolar bony defect sites
Materialof Fixture	Pure Titanium Grade 4 (ASTM F67)	Pure Titanium (ASTM F67)
Diameter	4.0	4.0
Height	1.52	1.5
Sterilization	Sterilie	Sterilie
Shelf life	5years	-
S E	The Cover Cap has same material and indication for use and similar design andtechnological characteristics as the predicate device, such as the CTi Cover Cap

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OSSTEM Implant Co., Ltd. #507-8 Geoie3-Dong Yeonie-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

1. Indication for use :
  The SMARTbuilder system is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
1. Review :
  The SMARTbuilder system has the same material and indication for use and similar design and technological characteristics as the predicate device.
1. Summary of nonclinical testing
  Biocompatibility evaluation for SMARTbuilder System is not considered because SMARTbuilder System, which is made with titanium alloy, has been generally and widely used as a dental material such as implant for a long time
1. Summary of clinical testing No clinical studies are submitted
1. Conclusion :

Based on the information provided in this premarket notification Osstem Implant Co., Ltd. concludes that the SMARTbuilder system is substantially equivalent to the predicate devices as described herein

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services, USA. The logo consists of a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, represented by thick, stylized lines.

Public Health Service

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

OCT
3 2012

Osstem Implant Company, Limited C/O Mr. Patrick Lim Hiossen, Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K120951

Trade/Device Name: SMARTbuilder System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, NHA Dated: August 28, 2012 Received: September 12, 2012

Dear Mr. Lim:

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- Mr. Lim

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 reportung (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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

R. Staley

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,

Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

510(k) Number K_12095 1

Device Name : SMARTbuilder system

Indication for use : SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Prescription Use X (Per 21CFR801 Subpart D) OR

Over-The-Counter Use (Per 21 CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K12095

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.