The Orthodontic Screw 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. Screws are intended for single use only

Device Description

The Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.4, 1.6 and 1.8mm in screw diameter and 6, 8, 10mm in length. It is made of Titanium alloy (Ti-6AI-4V ELI, ASTM F 136- 02A). The surface of the screw is non-treated.

AI/ML Overview

The provided text describes the 510(k) summary for the OSSTEM Implant Co., Ltd.'s Orthodontic Screw. However, it does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based device.

The "device" in this context is a physical Orthodontic Screw, and the review focuses on its substantial equivalence to a predicate device, primarily through material, design, and non-clinical mechanical testing, not through performance metrics of an AI.

Therefore, many of the requested fields related to AI performance are not applicable. I will fill in the relevant available information based on the document provided.

Acceptance Criteria and Study for OSSTEM Implant Orthodontic Screw

This submission is for a physical medical device (Orthodontic Screw), not an AI/algorithm-based device. Therefore, the acceptance criteria and study detailed here focus on non-clinical performance and substantial equivalence to a predicate device, rather than AI performance metrics, ground truth establishment, or human-in-the-loop studies.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Study Type
Fracture load test	In compliance with Osstem standard (OS-C-0013)	Non-clinical testing
Rotational fracture torque test	In compliance with Osstem standard (OS-C-0012)	Non-clinical testing
Material	Titanium alloy (Ti-6Al-4V ELI, ASTM F 136-02A) - Same as predicate	Comparison to predicate
Indication for Use	Fixed anchorage point for orthodontic appliances - Same as predicate	Comparison to predicate
Sterilization	Radiation Sterile - Same as predicate	Comparison to predicate
Shelf life	5 years - Same as predicate	Comparison to predicate
Biocompatibility	Performed to comply with US & International regulations	Safety testing

2. Sample size used for the test set and data provenance:

Test set sample size: Not explicitly stated for the non-clinical tests (fracture load, rotational fracture torque). These tests would typically involve a statistically relevant number of physical samples, but the specific quantity is not provided in this summary.
Data provenance: The tests were conducted internally by OSSTEM Implant Co., Ltd. ("Osstem standard"). The country of origin for the data is implicitly Republic of Korea (where OSSTEM is based). The data is from non-clinical (laboratory) testing.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable for this type of device and testing. Ground truth for mechanical tests is established by physical measurement against engineering standards, not expert consensus.

4. Adjudication method for the test set:
Not applicable. Mechanical test results are quantitative and do not require expert adjudication in the same way clinical or image-based assessments do.

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 is not an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device.

7. The type of ground truth used:
For the non-clinical tests (fracture load, rotational fracture torque), the "ground truth" or reference was Osstem internal standards (OS-C-0013 and OS-C-0012). For substantial equivalence, the ground truth was the characteristics of the predicate device (Super Orthodontic Screw, K062156).

8. The sample size for the training set:
Not applicable. This is not an AI device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established:
Not applicable.

Summary

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Kl03105

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) Summary

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

Date: Oct 6, 2010

Company and Correspondent making the submission:

OSSTEM Implant Co., Ltd. - Submitter's Name : #507-8 Geoje3-Dong Yeonie-Gu - Address : Busan, 611-804, Republic of Korea 82 51 850 2574 - Telephone No. - Contact : Mr. JongHyuk Seo 2. Device :

Orthodontic Screw System Dental implant, endosseous, orthodontic 21CFR872.3640 Class II OAT

3. Predicate Device :

Trade or (Proprietary) Name :

Common or usual name :

Classification Name :

The Super Orthodontic Screw System, OSSTEM Implant Co., Ltd, K062156

1. Description :
  The Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.4, 1.6 and 1.8mm in screw diameter and 6, 8, 10mm in length. It is made of Titanium alloy (Ti-6AI-4V ELI, ASTM F 136- 02A). The surface of the screw is non-treated.

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OSSTEM Implant Co., Ltd. SSTEM®

#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

	Orthodontic screw	Predicate devices
		Super Orthodontic screw(K062156)
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd
IndicationFor Use	The Orthodontic Screw isindicated for use as a fixedanchorage point for attachment oforthodontic appliances to facilitatethe orthodontic movement of teeth.It is used temporarily and isremoved after orthodontictreatment has been completed.Screws are intended for single useonly	The Super Orthodontic Screw isindicated for use as a fixedanchorage point for attachment oforthodontic appliances to facilitatethe orthodontic movement of teeth.It is used temporarily and isremoved after orthodontictreatment has been completed.Screws are intended for single useonly
Structure	Through Hole : Wire holeSimple Head : No holeTapered body	SlotWire holeTapered body
Diameter (D)Length (mm)	Refer to the Table 1
Material ofFixture	Titanium alloy (Ti-6Al-4V ELI)(ASTM F 136-02A)	Titanium alloy (Ti-6Al-4V ELI)(ASTM F 136-02A)
Sterilization	Radiation Sterile	Radiation Sterile
Shelf life	5 years	5 years
S & E	The Orthodontic screw system has same material and indication for useand similar design and technological characteristics as the predicatedevice.

Orthodontic screw		Predicate devices
(Ø)	(mm)	Super Orthodontic screw (K062156) (Ø)	(mm)
1.4	6.0, 8.0	-	-
1.6	6.0, 8.0, 10.0	1.6	6.0, 8.0, 10.0
1.8	6.0, 8.0, 10.0	1.8	6.0, 8.0, 10.0

Table 1. Diameter and length (Orthodontic screw and Predicate devices)

Indication for use :

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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

6. Review :

The Orthodontic screw system has same material and indication for use and similar design and technological characteristics as the predicate device.

The Orthodontic screw system has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

1. Summary of nonclinical testing
  Fracture load test was done in accordance with Osstem standard (Fracture & Bending test. OS-C-0013) and result is in compliance with it.

Rotational Fracture torque test was done in accordance with Osstem standard (Rotational Fracture torque test, OS-C-0012) and result is in compliance with it.

1. Summary of clinical testing No clinical studies are submitted
1. Conclusion :

Based on the information provided in this premarket notification Osstem concludes that the Orthodontic screw system is safe and effective and substantially equivalent to the predicate device as described herein.

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Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services USA. The logo features the department's emblem, which consists of a stylized human figure with three arms reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

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

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

MAR 2 5 2011

Re: K103105

Trade/Device Name: Orthodontic Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: February 23, 2011 Received: February 24, 2011

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 reporting (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/ReportalProblem/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 vours.

Antinom Onis

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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Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The logo is black and white and features the word "OSSTEM" in a stylized font, with the word "IMPLANT" underneath in a smaller font. There is a small degree symbol to the right of the word "OSSTEM".

SSTEM 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 10310S

Device Name: Orthodontic Screw

Indication for use : The Orthodontic Screw 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. Screws are intended for single use only

Prescription Use X (Per 21CFR801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumer

(Division Sign-Off) (Division Sign-chi) Division Control, Dental Devices

510(k) Number: K163185

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.