The BR Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. BR Type Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Device Description

The BR Implant System is a dental implant system made of CP Ti Gr 4 / ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The surface of the implants has been treated with R.B.M (Resorbable Blast Media) with acid etch. The BR Type Implant System is offered in the following sizes. Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Abutments, Angled Abutments, Cemented Abutments (Hex, Non-hex), and Solid Abutments) for restorations. Small diameter implants and angled abutments are not recommended for the posterior region. They are made of Titanium Grade 4 / ASTM F67, and provided as non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (BR Type Implant System), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of regulatory submission does not typically include detailed study reports with acceptance criteria and device performance metrics in the way a clinical trial or a performance study for a novel AI device would.

The document primarily focuses on demonstrating substantial equivalence through comparisons of design, materials, indications for use, and non-clinical testing to established standards. It does not contain the specific information requested about acceptance criteria, detailed device performance metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment for a machine learning or AI-based device.

Therefore, I cannot extract the requested information from the provided text for the following reasons:

No specific acceptance criteria or reported device performance for an AI/ML component: The document discusses non-clinical tests for a dental implant system (e.g., sterilization, fatigue, biocompatibility) against ISO standards, not performance metrics for an AI algorithm.
No test set sample size, data provenance, or ground truth details: These are not relevant for a physical medical implant's 510(k) submission, which focuses on similarity to an existing device.
No mention of experts, adjudication, MRMC studies, or standalone performance: These concepts apply to the evaluation of diagnostic or assistive AI systems, not to the premarket notification of a dental implant.
No training set information: There is no AI/ML component described, so no training set is relevant.

The document lists "Non-Clinical Test data" which refers to standard engineering and biocompatibility tests for a physical implant, such as:

Sterilization Validation testing (ISO 11137, ISO 11737-1&2 for gamma; ISO 17665-1&2 for steam)
Surface Characteristics Test Report (Chemical and SEM image analyses)
Shelf-life and packaging material validation (ISO 11607, ISO 11137, ISO 11737, ASTM F1980, ASTM D882, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096, ASTM F1608)
Comparative Fatigue testing (ISO 14801:2007)
Cytotoxicity Test (ISO 10993-5:2009)
Sensitization test (ISO 10993-10:2010)

These tests "met the criteria of the standard," allowing the device to claim substantial equivalence. However, these are not the type of acceptance criteria and performance metrics used for an AI/ML medical device as implied by your question.

In summary, the provided document does not contain the information required to populate the requested table and answer the specific questions related to the acceptance criteria and study of an AI-powered device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full agency name on the right. The seal features an emblem with a staff entwined by a serpent, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Biotem Co.,Ltd. % Joyce Bang Consultant Provision Consulting Group Inc. 1370 Valley Vista Dr. Suite 200 Diamond Bar, California 91765

Re: K171179

Trade/Device Name: BR Type Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 2, 2017 Received: January 10, 2018

Dear Joyce Bang:

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 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 of medical device-related adverse events) (21 CFR 803); good

February 9, 2018

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -S

For Tina Kiang, Ph.D. 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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Indications for Use

510(k) Number (if known) K171179

Device Name BR Type Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY

Submitter:

Hong Koo Yeo Biotem Co., Ltd. 57, Sasang-ro , 401 beon-gil , Sasang-gu, Busan , Korea Tel : +82-70-8220-4934 Fax : +82-51-908-8257

Official Correspondent/ US Agent:

Joyce Bang Consultant, Provision Consulting Group, Inc. 1370 Valley Vista Dr. Suite 200, Diamond Bar, CA 91765 +1-909-550-0131 Ext.1131 provisionfda@gmail.com info@provisionfda.com

Date Prepared: 02/08/2018

Device Information:

Device Name: BR Type Implant System Classification Name: Endosseous Dental Implant Common Name: Endosseous Dental Implant Classification: Class II Product Code: DZE Subsequent Product Code: NHA Regulation number: 21 CFR 872.3640

Predicate Device: K062030, US System manufactured by Osstem Implant Co., Ltd.

Reference Device: K172240, SPI Dental Implant System manufactured by MSI France

Indication for use

Device Description

Fixture

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Platform	Body Diameter	Total Length (mm)
Ø 3.5	Ø 3.3	8.5, 10.0, 11.5, 13.0, 15.0
Ø 4.1	Ø 3.7	7.5, 8.5, 10.0, 11.5, 13.0, 15.0
Ø 4.1	Ø 4.0	7.5, 8.5, 10.0, 11.5, 13.0, 15.0
Ø 5.0	Ø 5.0	7.5, 8.5, 10.0, 11.5, 13.0, 15.0
Ø 5.1	Ø 5.0	7.5, 8.5, 10.0, 11.5, 13.0, 15.0
Ø 5.1	Ø 6.0	7.5, 8.5, 10.0, 11.5, 13.0, 15.0

Abutment

Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Abutments, Angled Abutments, Cemented Abutments (Hex, Non-hex), and Solid Abutments) for restorations. Small diameter implants and angled abutments are not recommended for the posterior region. They are made of Titanium Grade 4 / ASTM F67, and provided as non-sterile.

Abutments	Connection	Sizes
		Angulation (°)	Cuff Heights (mm)	Platform diameter (Ø)
Angled abutment	Assembled with Fixture and angled Abutment by connecting abutment body with set screw. The connection type is External Hexagon shape.	15, 25	2, 4	4.0, 5.0, 6.0
Cemented Abutment	Assembled with fixture and cemented abutment by connecting abutment body with set screw. The connection type is External Hexagon shape.	0	1,2,3,4	4.0, 5.0, 6.0
Healing Abutment	Assembled with Fixture and Healing Abutment by inserting the screw part. And the connection is External Hexagon shape.	0	2,3,4,5,7	4.0, 5.0, 6.0
Cover Screw	Assembled with Fixture by inserting screw part. And the connection is External Hexagon shape	0	2.7	3.5, 4.1, 5.0, 5.1

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Substantial Equivalence Comparison Chart

	Subject Device	Predicate Device
510(k) Number	K171179	K062030
Device Name	BR Type Implant System	US System
Manufacturer	Biotem Co., Ltd.	Osstem Implant Co., Ltd.
Indications for Use	indicated for use in partially or fullyedentulous mandibles and maxillae, insupport of single or multiple-unitrestorations including; cemented retained,screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework. BR TypeImplant System is for single and twostage surgical procedures. It is intendedfor delayed loading.	US system and SSII mini are indicated foruse in partially or fullyedentulous mandibles and maxillae, insupport of single or multiple-unitrestorations including; cemented retainedscrew retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework. US Systemis for two stage surgical procedures. It isnot for one stage surgery or immediateload. The SSII mini is for one and twostage surgical procedures. It is not forimmediate load.
Design	External Hex Type	External Hex Type
Material	CP Ti Grade 4ASTM F67	CP Ti Gr 4ASTM F67
Sterilization	Gamma sterilization	Gamma sterilization
	$Ø$ 3.5, x $Ø$ 3.3 x 2.4mm x (8.5mm, 10mm,11.5mm, 13mm, 15mm)	$Ø$ 3.5, x $Ø$ 3.3 x 2.4mm x (8.5mm, 10mm,11.5mm, 13mm, 15mm)
FixturePlatform( $Ø$ ) x Bodydiameter( $Ø$ ) x hex(mm) xlength(mm)	$Ø$ 4.1, x ( $Ø$ 3.75, $Ø$ 4.0) x 2.7mm x (7.5mm,8.5mm, 10mm, 11.5mm, 13mm, 15mm)$Ø$ 5.1, x ( $Ø$ 5.0, $Ø$ 6.0) x 3.4mm x (7.5mm,8.5mm, 10mm, 11.5mm, 13mm, 15mm)$Ø$ 5.0, x $Ø$ 5.0 x 2.7mm x (7.5mm, 8.5mm,10mm, 11.5mm, 13mm, 15mm)	$Ø$ 4.1, x $Ø$ 4.0 x 2.7mm x (7mm, 8.5mm,10mm, 11.5mm, 13mm)$Ø$ 5.1, x $Ø$ 5.0 x 3.4mm x (6mm, 7mm,8.5mm, 10mm, 11.5mm, 13mm)$Ø$ 5.0, x $Ø$ 5.0 x 2.7mm x (6mm, 7mm,8.5mm, 10mm, 11.5mm, 13mm)
Angled abutmentPlatform( $Ø$ ) x cuff size(mm) xLength(mm) x Angulation(°)	$Ø$ 4.0 x (2mm, 4mm) x (7mm) x (15°, 25°)$Ø$ 5.0 x (2mm, 4mm) x (7mm) x (15°, 25°)$Ø$ 6.0 x (2mm, 4mm) x (7mm) x (15°, 25°)	$Ø$ 4.0 x (2mm, 4mm) x (7mm) x (15°, 25°)$Ø$ 5.0 x (2mm, 4mm) x (7mm) x (15°, 25°)$Ø$ 6.0 x (2mm, 4mm) x (7mm) x (15°, 25°)
Cemented AbutmentPlatform( $Ø$ ) x cuff size(mm) xlength(mm)	$Ø$ 4.0 x (2mm, 4mm) x (6mm ,7.5mm)$Ø$ 5.0 x (1mm, 2mm, 3mm, 4mm) x (4mm,5.5mm, 7mm)$Ø$ 6.0 x (1mm, 2mm, 3mm, 4mm) x (4mm,5.5mm)	$Ø$ 4.0 x (2mm, 4mm) x (7.5mm)$Ø$ 5.0 x (1mm, 2mm, 3mm, 4mm) x (4mm,5.5mm, 7mm)$Ø$ 6.0 x (1mm, 2mm, 3mm, 4mm) x (4mm,5.5mm)
Healing AbutmentPlatform( $Ø$ ) x cuff size(mm)	$Ø$ 4.0 x (2mm, 4mm)$Ø$ 5.0 x (2mm, 3mm, 4mm, 5mm, 7mm)$Ø$ 6.0 x (2mm, 3mm, 4mm, 5mm)	$Ø$ 4.0 x (3mm, 5.5mm)$Ø$ 5.0 x (2mm, 3mm, 4mm, 5.5mm, 7mm)$Ø$ 6.0 x (3mm, 5.5mm)
Surface treatment	RBM	RBM
Product Code	DZE, NHA	DZE, NHA

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The difference in the Indications for Use Statement regarding "immediate loading" and "delayed loading" have been made to reflect the more recent clearances to include positive indications in the Indications for Use Statement.

The BR Type Implant System has a substantially equivalent intended use as the identified predicate (K062030). Both are used for mandible and maxilla endosseous dental implant and accessories. The BR Type 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. The subject and predicate devices are both bone-level implants that share similar neck design and cutting edge. The subject and predicate devices are similar in size, surface treatment and materials. The Ø5.0 and Ø6.0 fixtures (implants) with the length of 15mm technological features (diameter and length) are similar to the reference device K172240.

Non-Clinical Test data

The subject device was tested to evaluate its performance as below.

Sterilization Validation testing for sterile devices (fixtures) has been performed in accordance with ISO 11137, ISO 11737-1& ISO 11737-2 for gamma sterilization
Steam Sterilization validation for non-sterile devices (abutments) has been performed in accordance with ISO 17665-1 and ISO 17665-2.
Surface Characteristics Test Report Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixtures.
Shelf-life and packaging material has been validated according to ISO 11607, ISO 11137 and ISO 11737. Accelerated aging, strength, and integrity were performed to ASTN F1980, ASTM D882, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and ASTM F1608. Shelf life for the fixture was determined to be 3 years.
Comparative Fatigue testing of the subject device and predicate device has been performed in accordance with ISO 14801:2007.
· Cytotoxicity Test performed according to ISO 10993-5:2009
· Sensitization test performed according to ISO 10993-10:2010

Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests have met the criteria of the standard, and proved the substantial equivalence with the predicate device. 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 subject device is substantially equivalent to the predicate device.

Conclusions

Overall, the BR Type Implant System has the following similarities to the predicate devices:

*has the same intended use,
*uses the same operating principle,
*incorporates the same basic design,

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*incorporates similar material and the surface treatment.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, we conclude that the BR Type Implant System is substantially equivalent to the 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.