The Dual Top Screw System is a temporary fixation and screws in various configurations, shapes and sizes. The Dual Top Screw System is made of Titanium Alloy (Ti-6AL-4V), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The head of the screw is dual head of the Dual Top Anchor System screw is designed to apply various orthodontic tools. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Also, dual head design of screw accommodates the use of the screw with the orthodontic appliances (bracket, wire, and elastic band etc.) The sizes of the Dual Top System are diverse enough to satisfy various clinical cases. The Dual Top System screws are provided either non-sterilized or gamma-sterilized.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Dual Top Screw System," an endosseous dental implant (temporary anchor for orthodontic treatment). This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific performance acceptance criteria through the kind of study typically performed for AI/ML devices.

Therefore, the information requested regarding acceptance criteria, performance studies and ground truth establishment, which are typical for AI/ML device submissions, is not present in this document. This submission is for a physical medical device (an orthodontic screw) and relies on bench testing and material conformity to established standards to demonstrate equivalence to a predicate device.

Here's why the requested information cannot be found based on the provided text:

Acceptance Criteria/Reported Device Performance (Table): The document doesn't provide specific numerical performance metrics (e.g., accuracy, precision) for the device. Instead, it states that "The results of this testing indicate that the Dual Top Screw System is equivalent to predicate devices." This is satisfied through demonstrating similar mechanical properties and biocompatibility.
Sample Size for Test Set and Data Provenance: No clinical test set data is provided, as "No clinical studies were necessary for the demonstration of substantial equivalence." The bench tests mentioned (Axial Pullout, Torsional Property, Driving Torque) would have sample sizes for the devices tested, but these aren't specified in the summary.
Number of Experts/Qualifications/Adjudication Method: These points are relevant for studies that establish ground truth, typically in the context of diagnostic or AI-powered devices where human expert consensus is used. Since no clinical studies or AI components are mentioned, these are not applicable.
MRMC Comparative Effectiveness Study: This is a type of study specifically for evaluating the impact of AI on human reader performance. As this is not an AI/ML device, such a study was not conducted.
Standalone Performance: This refers to the algorithm-only performance of an AI/ML device. Not applicable here.
Type of Ground Truth: Ground truth for AI/ML is typically established by expert consensus, pathology, or outcomes data. For this physical device, "ground truth" is defined by material standards (ASTM F136) and established mechanical testing protocols (ASTM 543).
Sample Size for Training Set and How Ground Truth was Established for Training Set: These are concepts entirely related to AI/ML model development. They are not relevant for this traditional medical device submission.

In summary, the provided document outlines the substantial equivalence approach for a physical medical device, which differs significantly from the performance study requirements for AI/ML devices or novel diagnostic tools. The "acceptance criteria" here are largely met by conformity to material standards and comparable mechanical performance to predicate devices through bench testing, not clinical performance metrics or expert-adjudicated ground truth.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.

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

February 23, 2017

Jeil Medical Corporation Seungyoung Lee RA Specialist 702 · 703 · 704 · 705 · 706 · 805 · 807 · 812-ho, 55, Digital-ro34-gil, Guro-gu, Seoul, 08378 KOREA

Re: K161335

Trade/Device Name: Dual Top Screw System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: January 24, 2017 Received: January 25, 2017

Dear Seungyoung Lee:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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,

Michael J. Ryan -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) K161355

Device Name Dual Top Screw System

Indications for Use (Describe)

The Dual Top Screw System is intended for use as a temporary anchor treatment for use in patients aged 12 and older.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION, followed by the address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The phone number is Tel: +82 2 850 3533 and the fax number is Fax: +82 2 850 3535. The logo includes a graphic of three stylized figures in green, gray, and orange.

510(k) Summary

[As required by 21 CRF 807.92]

1. Date Prepared [21 CRF 807.92(a)(1)]

21 February 2017

Submitter's Information [21 CFR 807.92(a)(1)] 2.

Name of Sponsor: Jeil Medical Corporation . -Address: 702·703·704·705·706·804·805·807·812-ho,55 Digital-ro34-gil, Guro-gu, Seoul, 08378, Korea . Contact Name: Seungyong Lee / RA Specialist
- -Telephone No. : +82 2 850 3533
- Fax No. : -+82 2 850 3525
- Email Address : leesy@jeilmed.co.kr
Registration Number: 3004049923 ●
Name of Manufacturer: . Same as Sponsor
- Address: Same as Sponsor

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.

. Trade Name: Dual Top Screw System . Common Name: Implant, Endosseous, Orthodontic . Classification Name: Endosseous Dental Implant Classification Panel: Dental . Classification Regulation: . 21 CFR 872.3640 . Product Code: OAT . Device Class: II
Dual Top Screw System

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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow;

• Primary Predicate:	K063495
• Applicant:	Biomaterials Korea, Incorporated
• Common Name:	Implant, Endosseous, Orthodontic
• Device Name:	The C-Type, CT Type and Special Type

Common Name: Implant, Endosseous, Orthodontic ●
Device Name: PSM LOMAS / BENEFIT Screws ●

Orthodontic Anchor Screw

There are no significant differences between the Model Dual Top Screw System and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, and operational principles as internal fixation components.

5. Description of the Device [21 CFR 807.92(a)(4)]

The Dual Top Screw System is a temporary fixation and screws in various configurations, shapes and sizes as follow;

	The Dual Top Screw System
Head Design	JASeries	JBSeries	G1Series	G2Series	JDSeries	JOSeries	JSSeries	JFSeries	JKSeries
The type oforthodonticappliance	ElasticBand,Archwire	ElasticBand,NiTiSpring	Archwire	ElasticBand,Archwire	Archwire	Archwire,NiTiSpring	ElasticBand	ElasticBand,Archwire	ElasticBand
Length	5,6,7,8,10,12 mm	5,6,7,8,10,12 mm	5,6,7,8,10,12 mm	5,6,7,8,10,12 mm	5,6,7,8,10,12 mm	5,6,7,8,10,12 mm	10,11,12,14,16mm	5,6,7,8,10,12 mm	5,6,7,8,10,12 mm
diameter	$Ø$ 1.3~$Ø$ 2.0	$Ø$ 1.3~$Ø$ 2.0	$Ø$ 1.3~$Ø$ 2.0	$Ø$ 1.3~$Ø$ 2.0	$Ø$ 1.3~$Ø$ 2.0	$Ø$ 1.3~$Ø$ 2.0	$Ø$ 2.0~$Ø$ 2.5	$Ø$ 1.4~$Ø$ 2.0	$Ø$ 1.4

The Dual Top Screw System is made of Titanium Alloy (Ti-6AL-4V), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The head of the screw is dual head of the Dual Top Anchor System screw is designed to apply various orthodontic tools. There is a hole in the screw head through which a

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Image /page/5/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. Below the logo is the address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The phone number is +82 2 850 3533 and the fax number is +82 2 850 3535.

wire can be passed to fix the mandible and maxilla in orthodontic treatment. Also, dual head design of screw accommodates the use of the screw with the orthodontic appliances (bracket, wire, and elastic band etc.) The sizes of the Dual Top System are diverse enough to satisfy various clinical cases. The Dual Top System screws are provided either non-sterilized or gamma-sterilized.

6. Indications for Use [21 CFR 807.92(a)(5)]

The Dual Top Screw System is intended for use as a temporary anchor for orthodontic treatment for use in patients aged 12 and older.

7. Technological Characteristics [21 CFR 807.92(a)(6)]

Dual Top Screw System Endosseous Dental Implant: They share similar head, neck and thread designs as the smaller screws that are currently cleared under the predicate devices.

	Subject Device	Primary Predicate	Reference Predicate
510K Number	K161335	K063495	K110392
Product name	Dual Top Screw System	The C-Type, CT Type andSpecial Type OrthodonticAnchor Screws	PSM LOMAS / BENEFITScrews
Manufacturer	Jeil Medical Corporation	Biomaterials KoreaIncorporated	PSM MEDICALSOLUTIONS
Indications for Use	The Dual Top ScrewSystem is intended for useas a temporary anchor fororthodontic treatment foruse in patients aged 12 andolder.	Intended for use as atemporary anchor fororthodontic treatment.	The PSM LOMAS /BENEFITScrews are intended toprovide a fixed anchoragepoint for attachment oforthodontic appliances tofacilitate the orthodonticmovement of teethin adolescents greater than12years of age and adults. Thedevices are usedtemporarily and areremoved after orthodontictreatment has beencompleted. Screws areintended for single useonly.
Design	Screw- Thread Diameter; Ø 1.3~Ø 2.5- Thread Depth: 0.15 ~0.55mm	Screw- Thread Diameter; Ø 1.2~Ø 2.0- Thread Depth: Ø 1.2:0.14mm	Screw- Thread Diameter; Ø 1.5~Ø 2.3- Length; 7~15mm
	- Length; 5~16mm	- Length; 5~12mm
Materials	Titanium Alloy (ASTMF136)	Titanium Alloy (ASTMF136)	Titanium Alloy (ASTMF136)
Surface Treatment	No surface treatment	Anodized	Anodized

Dual Top Screw System

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Image /page/6/Picture/0 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The logo features the company name in a stylized font, with a graphic element to the left. Below the logo is the company's address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The phone and fax numbers are also listed: Tel: +82 2 850 3533 / Fax: +82 2 850 3535.

Sterilization	Non-Sterile(Steam sterilized by user)or Gamma- Sterilized	Non-Sterile(Steam sterilization by user)	Gamma- Sterilized
---------------	-------------------------------------------------------------------	----------------------------------------------	-------------------

The results of this testing indicate that the Dual Top Screw System is equivalent to predicate devices.

8. Non-Clinical Testing Summary

Comparative bench tests were conducted to demonstrate substantial equivalence to the primary predicate device (K063495). The following tests were conducted using FDA recognized standard methods:

Axial Pullout test: ASTM 543
Torsional Property test: ASTM 543
Driving Torque test: ASTM 543
Biocompatibility test:

The subject device is manufactured from Titanium alloy (conforming with ASTM F136) with a history of safe use. Cytotoxicity testing per ISO 10933-5 was performed to mitigate the risks associated with materials used during manufacturing

9. Clinical Testing Summary

No clinical studies were necessary for the demonstration of substantial equivalence.

10. Conclusion [21 CFR 807.92(b)(3)]

The subject device is made of the same materials and has similar dimensions and characteristics as the primary predicate device. The subject device is manufactured from material of the Titanium Alloy that is used generally in this kind of endosseous dental implant system. The subject device, Dual Top Screw System, is substantially equivalent in intended use and technological characteristics to the primary predicate device (K063495).

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.