The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is intended for use as a temporary anchor for orthodontic treatment for use in patients aged 12 and older.

Device Description

The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is an orthodontic screw used for straightening of irregular teeth. It is designed for indications such as malocclusion treatment, straightening of irregular teeth, improvement of intermaxillary space and occlusion, and maintenance after orthodontic treatment. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices and it is used temporarily, removed after orthodontic treatment has been completed. Orthodontic screw is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures. Orthodontic Fixation Screw [Smart Anchor Miniscrew] is made of Titanium Alloy (T)-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 through hole head type. The head of the Orthodontic Fixation Screw [Smart Anchor Miniscrew] 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, the design accommodates the use of the screw with the orthodontic appliances (bracket, wire, and elastic band etc.). The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is available in in diameters of 1.2, 1.4, 1.6, 1.8, and 2.0mm and lengths of 8 and 10mm. The Orthodontic Fixation Screws with a diameter of 1.4mm and greater are also available in a 6mm length version.

AI/ML Overview

The provided text is a 510(k) summary for the "Orthodontic Fixation Screw [Smart Anchor Miniscrew]". This document describes the device and its equivalence to predicate devices, focusing on bench testing rather than clinical studies or AI-based performance.

Therefore, the requested details regarding acceptance criteria for AI/ML performance, study types (MRMC, standalone), ground truth establishment, expert adjudication, and sample sizes for training/test sets are not present in this document. The document confirms that no clinical performance testing was necessary for the demonstration of substantial equivalence.

The acceptance criteria provided in this document are primarily for the physical and mechanical properties of the orthodontic screw, demonstrating substantial equivalence to a predicate device.

Here's what can be extracted from the provided text regarding acceptance criteria and the study:

Acceptance Criteria and Device Performance (Based on Bench Testing for Substantial Equivalence)

Acceptance Criteria Category	Specific Test/Parameter	Acceptance Criteria (Implicit from Equivalence Claim)	Reported Device Performance (Implicit from Equivalence Claim)
Material Biocompatibility	Cytotoxicity (ISO 10993-5)	Meets applicable requirement of ISO 10993	Performed, meets standards for Titanium Alloy (ASTM F136)
	Hypersensitivity (ISO 10993-10)	Meets applicable requirement of ISO 10993	Performed, meets standards for Titanium Alloy (ASTM F136)
	Intracutaneous Reactivity (ISO 10993-10)	Meets applicable requirement of ISO 10993	Performed, meets standards for Titanium Alloy (ASTM F136)
	Acute Systemic Toxicity (ISO 10993-11)	Meets applicable requirement of ISO 10993	Performed, meets standards for Titanium Alloy (ASTM F136)
	Local Effect after Implantation (ISO 10993-6)	Meets applicable requirement of ISO 10993	Performed, meets standards for Titanium Alloy (ASTM F136)
Sterilization	Moist Heat Sterilization Validation	Validated per ISO 17665-1 and ISO 17665-2	Validated per ISO 17665-1 and ISO 17665-2 (Non-Sterile, Steam sterilized by user)
Mechanical Performance	Axial Pullout Strength Test	Demonstrated substantial equivalence to predicate (K161335)	Comparative bench test conducted using ASTM 543-13; differences in diameter addressed with reference device. Performance not quantified but deemed equivalent.
	Torsional Strength Test	Demonstrated substantial equivalence to predicate (K161335)	Comparative bench test conducted using ASTM 543-13; performance not quantified but deemed equivalent.
	Insertion-Removal Torque Test	Demonstrated substantial equivalence to predicate (K161335)	Comparative bench test conducted using ASTM 543-13; performance not quantified but deemed equivalent.
	Fracture Load Test (for Ø 1.2mm)	Demonstrated substantial equivalence to reference device (K161197) with 1.2mm diameter	Conducted for Ø 1.2mm, performance not quantified but deemed equivalent.
	Rotational Fracture Torque Test (for Ø 1.2mm)	Demonstrated substantial equivalence to reference device (K161197) with 1.2mm diameter	Conducted for Ø 1.2mm, performance not quantified but deemed equivalent.
Dimensional/Visual	Visual and Dimension Check	Conforms to manufacturer's declared design characteristics	Tested and conformed.
Risk Management	Risk Analysis	Conducted based on ISO 14971:2012	Analysis conducted based on ISO 14971:2012.

Study Details:

The document describes non-clinical performance testing to demonstrate substantial equivalence, not a study involving AI/ML performance, human readers, or clinical outcomes.

Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML. For bench testing, samples of the device were used. No information on the number of devices tested is explicitly provided. The provenance of the data is from in-house bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and biocompatibility tests is established by physical measurements and laboratory analyses against established standards (ASTM, ISO).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "No clinical performance testing was necessary for the demonstration of substantial equivalence."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This device is an orthodontic screw, not an algorithm.
The type of ground truth used:
- For biocompatibility: Laboratory test results against ISO 10993 standards.
- For mechanical tests: Physical measurements (e.g., force, torque) against ASTM 543-13 and manufacturer's specifications, compared to predicate device performance.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, the provided FDA 510(k) clearance letter and summary pertain to a physical medical device (an orthodontic screw) and its demonstration of substantial equivalence through non-clinical (bench) testing, not through clinical or AI/ML performance studies. Therefore, many of the requested data points related to AI/ML device validation are not relevant to this document.

Summary

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August 28, 2020

GNI Co., LTD % Sang Hwa Myung Regulatory Affair Consultant E&M Consulting D-1474ho, 230 Simin-daero, Dongan-gu Anyang 14067 REPUBLIC OF KOREA

Re: K191041

Trade/Device Name: Orthodontic Fixation Screw [Smart Anchor Miniscrew] Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: July 20, 2020 Received: July 31, 2020

Dear Sang Hwa Myung:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191041

Device Name

Orthodontic Fixation Screw [Smart Anchor Miniscrew]

Indications for Use (Describe)

The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is intended for use as a temporary anchor for orthodontic 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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K191041

510(k) Summary

This summary of 510(k) Safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter: GNI Co., LTD 5F, 501: 5F 501, 63-12 Dongtancheomdansaneop 1-RO Hwaseong-si, Gyeonggido, 18469, South Korea Telephone: +82-505-600-8880 Fax: -82-505-333-8880 E-mail: admin_02@gniortho.com

Contact Person: Regulatory Affair/Sang Hwa Myung Telephone: +82-10-4952-6638 E-mail: mshenmc@gmail.com

Date 510(k) Summary Prepared: August 28, 2020

Trade Name (Brand name): Orthodontic Fixation Screw [Smart Anchor Miniscrew] Common Name: Implant, Endosseous, Orthodontic Regulation name: Endosseous Dental Implant Classification: Device Classification: Class II Classification Panel: Dental Product Code: OAT Regulation Numbers: 21 CFR 872.3640

Predicate Device:

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

Primary Predicate: K161335 Applicant: Jeil Medical Corporation Common Name: Implant, Endosseous, Orthodontic Device Name: Dual Top Screw System

Reference Device: K161197 Applicant: OSSTEM Implant Co., Ltd Common Name: Implant, Endosseous, Orthodontic Device Name: Orthodontic Screw

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Device Description:

It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices and it is used temporarily, removed after orthodontic treatment has been completed. Orthodontic screw is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures

Orthodontic Fixation Screw [Smart Anchor Miniscrew] is made of Titanium Alloy (T)-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 through hole head type. The head of the Orthodontic Fixation Screw [Smart Anchor Miniscrew] 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, the design accommodates the use of the screw with the orthodontic appliances (bracket, wire, and elastic band etc.). The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is available in in diameters of 1.2, 1.4, 1.6, 1.8, and 2.0mm and lengths of 8 and 10mm. The Orthodontic Fixation Screws with a diameter of 1.4mm and greater are also available in a 6mm length version.

Indications for use:

The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is intended for use as a temporary anchor for orthodontic treatment for use in patients aged 12 and older.

Substantial Equivalence:

	Subject Device	Predicate Device	Reference Device
Manufacturer	GNI Co., LTD	Jeil MedicalCorporation	OSSTEM Implant Co.,Ltd.
510(k)Number	K191041	K161335	K161197
CommonName	Implant, Endosseous,Orthodontic	Implant, Endosseous,Orthodontic	Implant, Endosseous,Orthodontic
Trade Name	Orthodontic FixationScrew (Smart AnchorMiniscrew)	The Dual Top ScrewSystem	Orthodontic Screw
Indications forUse	The OrthodonticFixation Screw[SmartAnchor Miniscrew] isintended for use as atemporary anchor fororthodontic treatmentfor use in patientsaged 12 andolder.	The Dual Top ScrewSystem is intended foruse as a temporaryanchor for orthodontictreatment for use inpatients aged 12 andolder.	The OrthodonticScrew is indicated foruse as a fixedanchorage point forattachment oforthodonticappliances to facilitatethe orthodonticmovement of teeth. Itis used temporarilyand is removed afterorthodontic treatmenthas been completed.Screws are intendedfor single use only

Table 1: Substantial equivalence comparison

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Design	Image: screw	Image: screw	Image: screw
Material	Titanium Alloy (ASTMF136)	Titanium Alloy (ASTMF136)	Titanium Alloy (ASTMF136)
SurfaceTreatment	Machined(not acid etched)	MachinedNo surface treatment	Machined(not acid etched)
Biocompatibility	Meets the applicablerequirement of ISO10993	Meets the applicablerequirement of ISO10993	Meets the applicablerequirement of ISO10993
Screw BodyDiameter(Ø)	Ø 1.2, Ø 1.4, Ø 1.6, Ø1.8, Ø 2.0	Ø 1.4, Ø 1.6, Ø 1.8 ,Ø2.0	Ø 1.2, Ø 1.4, Ø 1.6, Ø1.8, Ø 2.0
Length(mm)	6, 8, 10mm	6, 8, 10mm	6, 8, 10mm
TargetPopulation	Professional use onlyqualified dentists.Strictly reserved tospecialized and trainedusers.	Professional use onlyqualified dentists.Strictly reserved tospecialized andtrainedusers.	Professional use onlyqualified dentists.Strictly reserved tospecialized andtrainedusers.
Shelf life	5 years	None	8 years
Sterilization	Non-Sterile(Steam sterilized byuser)	Non-Sterile(Steam sterilized byuser or Gamma-Sterilized	Radiation Sterile

Information provided in these 510(k) submissions shows that the Orthodontic Fixation Screw [Smart Anchor Miniscrew] is substantially equivalent to the predicate devices, in terms of indications for use, device design, function and performance related to technological characteristics. Predicate devices are made of the same material as the subject device, titanium Alloy (ASTM F136) same as our device material.

Differences between the proposed and predicate device are not expected to affect the overall performance of the device. These differences include diameter, length and head shape in design.

For diameter of Ø 1.2mm, performance tests were conducted, including Fracture Load Test. Rotational fracture torque test, and Axial pull-out strength test. The subject device. Orthodontic Fixation Screw [Smart Anchor Miniscrew], features a smaller diameter than does the primary predicate whose smallest diameter is 1.4mm. To address the smallest diameter device found in the subject device, a reference device having the same 1.2mm diameter was introduced to this submission. As a result, the diameter of Ø 1.2mm does not impact substantial equivalence of the subject device to its primary predicate.

Biocompatibility testing:

The subject device is manufactured from Titanium alloy (conforming with ASTM F136) with a history of safe use. Cytotoxicity testing per ISO 10993 was performed to mitigate the risks associated with materials used during manufacturing, including cytotoxicity, hypersensitivity, intracutaneous reactivity, acute systemic toxicity and bone implantation, according to following standard below:

ISO 10993-1 Biological Evaluation of Medical Devices –Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-5 Biological Evaluation of Medical Devices - Part 5 Cytotoxicity

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ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization

ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Tests for systemic toxicity

ISO 10993-6 Biological Evaluation of Medical Devices Part 6: Tests for local effect after implantation

ISO 10993-12 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials

Sterilization:

Device is provided Non-Sterile (Steam sterilized by end user). Sterilization by moist heat was validated by ISO 17665-1 and ISO 17665-2.

Non-clinical Performance Testing Summary:

Orthodontic Fixation Screw [Smart Anchor Miniscrew] tested visual and the dimension which is design characteristics based on manufacturer declared performance.

The following comparative bench tests were conducted to demonstrate substantial equivalence to the primary predicate device (K161335) using FDA recognized standard methods:

Axial Pullout Strength test: ASTM 543-13
Torsional Strength test: ASTM 543-13
Insertion-Removal Torque Test: ASTM 543-13

A risk analysis was conducted based on ISO 14971:2012 Medical devices – Application of risk management to medical devices.

Clinical Testing Summary:

No clinical performance testing was necessary for the demonstration of substantial equivalence.

Conclusion

The subject device has identical indications for use, 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 device. Differences in physical dimensions (screw body diameter) between the subject device and its primary predicate are addressed by the (K161197) reference device. The subject device, Orthodontic Fixation Screw [Smart Anchor Miniscrew], is substantially equivalent in intended use and technological characteristics to the primary predicate device as described in this summary .

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.