The ORTHO MI SYSTEM is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.

Device Description

The screw diameters and lengths vary as shown below. It is made of a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13).

Structure (head type)	Thread diameter and Length	Remark
Double head	- Ø1.4mm, 6.0/8.0mm	Exceptionally S5T (Double head) and S5R (Slot)
Button head	- Ø1.6mm, 6.0/8.0/10.0mm	are Ø1.8mm, 10.0 to 16.0mm per 1.0mm.
Wing	- Ø1.8mm, 6.0/8.0/10.0mm
Slot	- Ø2.0mm, 6.0/8.0/10.0/12.0mm

These size combinations are the same across all model types (Double Head, Wing, Slot) with exception case.

AI/ML Overview

The provided document is an FDA 510(k) Premarket Notification for the "ORTHO MI SYSTEM," an endosseous dental implant (orthodontic anchor screw). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies like those required for PMA (Premarket Approval).

Therefore, the document explicitly states: "No clinical data were necessary for the demonstration of substantial equivalence." This means there was no study performed to prove the device meets acceptance criteria in the way a clinical study for an AI/CADe device would.

Instead, acceptance criteria are met through bench testing demonstrating compliance with relevant performance and safety standards, and ensuring the device's technical characteristics and indications for use are substantially equivalent to marketed predicate devices.

Here's a breakdown of the missing and implied information based on the provided text:

Acceptance Criteria and Device Performance

Since no clinical study was conducted, there are no "acceptance criteria" in the sense of clinical performance metrics (like sensitivity, specificity, or reader improvement). The acceptance criteria are tied to bench test performance against established standards and the demonstration of substantial equivalence to predicate devices.

Acceptance Criteria (Implied from Bench Testing & Equivalence)	Reported Device Performance (from "Non-Clinical Test Conclusion")
Mechanical Performance: Compliance with ISO 19023:2018 (Dentistry Orthodontic anchor screws) and ASTM F543:2013 (Metallic medical bone screws).	"The test results demonstrated that the subject device complies with the following standards: ISO 19023: 2018, ASTM F543: 2013."
Sterilization, Shelf-life, and Packaging: Compliance with various ISO and ASTM standards related to radiation sterilization, microbiological methods, packaging, and accelerated aging.	"The test results demonstrated that the subject device complies with... ISO11137-1/2/3, ISO11737-1/2, ISO 11607-1/2, ASTM F1980, ASTM F88/F88M, ASTM F1140/F1140M, ASTM F2096, ASTM F1929, ASTM D882, ASTM F1886F1886M."
Sterilization for Non-Sterile Product: Compliance with ANSI/AAMI ST79:2017 and ISO 17665-1/2.	"The test results demonstrated that the subject device complies with... ANSI/AAMI ST79:2017, ISO 17665-1/2."
Biological Safety: Compliance with ISO 10993-1:2018 and FDA Guidance.	"Biological assessment has been performed according to ISO 10993-1:2018... and to the FDA Guidance document."
Substantial Equivalence: Material, Indications for Use, Operating Principles, Form, and Structure are similar to predicate device(s). Product Size, Sterilization methods, Single Use/Reuse, Packaging, and Shelf-life are comparable or within acceptable variations.	"The technological characteristics of subject device is same materials and has similar dimension as the predicate and/or reference device. The Indication for use of subject device is same as the predicate device." "The result of the comparative bench testing... demonstrate that all screws are similar performance with predicate and/or reference device."

Study Information (as requested, but largely N/A for this 510(k) submission)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No clinical test set was used. The "test set" for this submission would refer to the physical devices subjected to bench testing according to the specified standards. The number of devices tested is not detailed, but it would have been sufficient to meet the requirements of the standards cited.
- Data Provenance: Not applicable. No biological or clinical data was collected from patients or subjects. The data derived from physical testing of the device hardware.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts/Qualifications: Not applicable. There was no ground truth determination by experts in a clinical context. Bench testing relies on objective measurements against engineering and materials standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. No human interpretation requiring adjudication was involved.
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:
- MRMC Study: No. This device is an orthodontic anchor screw, a physical implant, not an AI/CADe system. Therefore, no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable in a clinical sense. The "ground truth" for this device's performance is adherence to established engineering, materials, sterilization, and biocompatibility standards, and demonstrating physical properties consistent with predicates.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.

In summary, the provided document details a 510(k) submission for a physical medical device (orthodontic anchor screw). These submissions do not typically involve clinical trials or studies like those conducted for AI/CADe devices, and therefore, most of the questions regarding clinical performance metrics, expert adjudication, or AI model training are not applicable. The "proof" of meeting acceptance criteria lies in comprehensive non-clinical (bench) testing demonstrating compliance with relevant consensus standards and establishing substantial equivalence to previously cleared predicate devices.

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 logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

October 15, 2021

Osteonic Co., Ltd. Lee Jisun Manager 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho 1202Ho, 1206Ho, 38 Digital-ro 29-gil Guro-gu, Seoul 08381 REPUBLIC OF KOREA

Re: K211992

Trade/Device Name: Ortho MI System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: July 14, 2021 Received: July 19, 2021

Dear Lee Jisun:

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 (QS) 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,

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211992

Device Name ORTHO MI 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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Image /page/3/Picture/0 description: The image contains the logo for Osteonic, a medical company. The logo features a blue geometric shape resembling a stylized diamond or cube, positioned to the left of the company name. The text "OSTEONIC" is written in a bold, sans-serif font, with the tagline "The Medical Explorer" appearing in a smaller font size beneath it.

510(k) Summary

The assigned 510(k) Number: K211992

01. Date of Submission: 2021.10.15

02. Applicant

LEE JISUN OSTEONIC Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1202Ho, 1206Ho, 38 Digital-ro 29-gil, Guro-gu, Seoul, Korea TEL: +82-2-6902-8411 FAX: +82-2-6902-8401 Email: jisun@osteonic.com

03. Submission Correspondent

04. Subject Device Identification

Trade Name: ORTHO MI SYSTEM Common Name: Non sterile, sterile orthodontic anchor screw Classification Name: Implant, Endosseous, Orthodontic Product Code: OAT Panel: Dental Regulation Number: 21 CFR 872.3640 Device Class: II

05. Indication for use

06. Predicate devices

Predicate device 510(k) Number: K103105 Device Name: Orthodontic screw Manufacturer: OSSTEM Implant Co., Ltd.

Reference device 510(k) Number: K161335 Device Name: Dual Top Screw System Manufacturer: Jeil Medical Corporation

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Image /page/4/Picture/0 description: The image contains a logo for a company called OSTEONIC. The logo consists of a blue geometric shape on the left and the company name "OSTEONIC" in bold, dark font on the right. Below the company name is the tagline "The Medical Explorer" in a smaller, lighter font.

07. Device Description

The screw diameters and lengths vary as shown below. It is made of a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13).

Structure (head type)	Thread diameter and Length	Remark
Double head	- Ø1.4mm, 6.0/8.0mm	Exceptionally S5T (Double head) and S5R (Slot)
Button head	- Ø1.6mm, 6.0/8.0/10.0mm	are Ø1.8mm, 10.0 to 16.0mm per 1.0mm.
Wing	- Ø1.8mm, 6.0/8.0/10.0mm
Slot	- Ø2.0mm, 6.0/8.0/10.0/12.0mm

These size combinations are the same across all model types (Double Head, Wing, Slot) with exception case.

08. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:

▪ Mechanical performance

ISO 19023: 2018 Dentistry Orthodontic anchor screws
ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws

▪ Sterilization, shelf-life and packaging for sterile product

ISO11137-1:2006/Amd.2:2018 Sterilization of health care products - Radiation - Part 1: Requirement, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
ISO11137-2:2013Sterilization of health care products -Requirements for validation and routine control - Radiation -Part 2: Establishing the sterilization dose
ISO11137-3:2017Sterilization of health care products -Requirements for validation and routine control - Radiation -Part 3: Guidance on dosimetric aspects
ISO11737-1:2018 Sterilization of medical devices - Microbiological methods- Part 1: Estimation of microorganisms on products
ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods- Part 2. Tests of sterility performed in the validation of a sterilization process
ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging system
ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
ASTM F1140/F1140M:2013 Standard test methods for internal pressurization failure resistance of unrestrained packages for medical applications
ASTM F2096:2011 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration - ASTM D882:2012 Standard test method for tensile properties of thin plastic sheeting.
ASTM F1886F1886M:2016 Standard Test Method for Determining Integrity of Seals for flexible packaging by visual inspection

· Sterilization for non-sterile product

ANSI/AAMI ST79:2017 Comprehensive guide to steam sterility assurance in health care facilities - ISO 17665-1:2006 Sterilization of health care products -- moist heat -- part 1: requirement, validation, and routine control of a sterilization process for medical devices.

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Image /page/5/Picture/0 description: The image shows the logo for Osteonic, a medical company. The logo features a stylized blue geometric shape resembling a stylized letter "O" or a series of interconnected rectangles. To the right of the geometric shape is the company name "OSTEONIC" in bold, dark gray letters. Below the company name is the tagline "The Medical Explorer" in a smaller, lighter font.

ISO TS 17665-2:2009 Sterilization of health care products - moist heat - part 2: guidance on the application of iso 17665-1.
ISO 11138-1:2017 Sterilization of health care products - biological indicators - part 1: general requirements

▪ Biological safety assessment

Biological assessment has been performed according to ISO 10993-1:2018, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and to the FDA Guidance document, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff", for the subject devices.

09. Clinical Test Summary

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

10. Substantially Equivalent Conclusion

	Table 1: Substantial Equivalence Comparison

Product Name	SUBJECT DeviceORTHO MI SYTEM(K211992)	PREDICATE DeviceOrthodontic screw (K103105)	REFERENCE DeviceDual Top Screw System(K161335)
Manufacturer	OSTEONIC Co., Ltd.	OSSTEM Implant Co., Ltd.	Jeil Medical Corporation
Product code	OAT	OAT	OAT
Regulatoryclass	Class II	Class II	Class II
RegulationNumber	21 CFR 872.3640	21 CFR 872.3640	21 CFR 872.3640
Indication foruse	The ORTHO MI SYSTEM isindicated for use as a fixedanchorage point for attachmentof orthodontic appliances tofacilitate the orthodonticmovement of teeth. It is usedtemporarily and is removedafter orthodontic treatment hasbeen completed. It is intendedfor single use only.	The Orthodontic Screw isindicated for use as a fixedanchorage point for attachmentof orthodontic appliances tofacilitate the orthodonticmovement of teeth. It is usedtemporarily and is removedafter orthodontic treatment hasbeen completed. Screws areintended for single use only.	The Dual Top Screw System isintended for use as a temporaryanchor for orthodontictreatment for use in patientsaged 12 and older.
OperatingPrinciples	Orthodontic anchorage screw isinserted into jaw and palatal tohelp the orthodontist move thecorrect teeth and stop thewrong teeth from moving in thewrong direction.	Orthodontic anchorage screw isinserted into jaw and palatal tohelp the orthodontist move thecorrect teeth and stop the wrongteeth from moving in the wrongdirection.	Orthodontic anchorage screw isinserted into jaw and palatal tohelp the orthodontist move thecorrect teeth and stop the wrongteeth from moving in the wrongdirection.
Material	Titanium alloy (Ti6Al4V)-ASTM F136	Titanium alloy (Ti6Al4V)-ASTM F136	Titanium alloy (Ti6Al4V)-ASTM F136
Form	Orthodontic Anchorage Screw	Orthodontic Anchorage Screw	Orthodontic Anchorage Screw
Structure	Double headButton headWingSlot	Through hole: wire holeSimple head: no holeTapered body	Double headButton headWingSlot
Color	Silver	Silver	Silver

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Image /page/6/Picture/0 description: The image shows the logo for Osteonic, a medical company. The logo features a blue diamond shape with a stylized "O" inside, next to the company name in bold, dark gray letters. Below the name is the tagline "The Medical Explorer" in a smaller, lighter font.

Product Size	Diameter: Ø1.4 to 2.0Thread Length: 6.0mm to16.0mm (included anunthreaded length under head)Diameter by thread lengthØ1.4mm- 6.0mm to 8.0mmØ1.6mm and Ø1.8mm- 6.0mmto 10.0mmØ2.0mm- 6.0mm to 12.0mmException -S5T and S5R-:Ø1.8mm- 10.0mm to 16.0mm)	Diameter: Ø1.4 to 1.8Thread Length: 6mm to 10mm	Diameter: Ø1.3 to 2.5Thread Length: 5mm to 16mm(included an unthreaded lengthunder head)
Sterilization	Non sterile (user sterilization)orSterile (Radiation)	Sterile (Radiation)	Non sterile (user sterilization)orSterile (Radiation)
Single Use/Reuse	Single use	Single use	Single use
Packaging	1 or 10ea / Pack	1ea / Pack	-
Shelf-life	Non sterile product- N/A,Sterile product-3 Years	5 Years	Non sterile product- N/A,Sterile product-5 Years

There are slightly different diameters and thread length between the subject and predicate device was added to support the difference diameters and lengths of the size of the subject device is included in the range of the predicate and reference device. The result of the comparative bench testing in line with ISO 19023 demonstrate that all screws are similar performance with predicate and/or reference device.

The technological characteristics of subject device is same materials and has similar dimension as the predicate and/or reference device.

The Indication for use of subject device is same as the predicate device.

Based on above, the subject device, ORTHO MI SYSTEM, is determined to be Substantially Equivalent (SE) to the predicate devices and reference device, Orthodontic screw (K103105) and Dual Top Screw System (K161335).

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.