The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

Device Description

The screws are manufactured from commercially SUS316L ( stainless steel ) and Ti-6AL-4V ( titanium alloy ) . The screws are available with thread diameter are from 1.3mm to 2.0 mm, and total lengths from 5mm to 17mm. There is a pair of self-tapping flutes and self-drilling flutes for easy insertion and removal. The design of smooth curve surface of screw head is comfortable to patients, and the screws with or without a 0.65mm diameter hole can supply different orthodontic methods for orthodontists.

AI/ML Overview

This document is a 510(k) premarket notification for the "Syntec orthodontic mini screws." It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study reporting on the device's performance against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and performance metrics is generally not present in this type of regulatory document.

However, I can extract the information that is available and explain why other details are missing:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This document does not describe acceptance criteria and reported device performance through a study. Instead, it asserts "substantial equivalence" to a predicate device. Substantial equivalence means the device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No test set or data provenance is detailed because this is not a clinical study report. The submission relies on demonstrating equivalence through comparison of materials, intended use, and general characteristics to a predicate device, rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No ground truth establishment by experts is mentioned as this is not a study assessing diagnostic accuracy or clinical outcomes requiring such a process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No adjudication method is mentioned.

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 device is a physical orthodontic mini screw, not an AI software or diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device, not an algorithm, so standalone performance in that context is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. Since no performance study against a ground truth is presented, this information is not included.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device, so there is no concept of a training set.

9. How the ground truth for the training set was established

Not Applicable. As above, there is no training set mentioned.

Summary of what is available in the document regarding the device and its regulatory clearance:

Device Name: Syntec orthodontic mini screws
Intended Use: To provide fixed anchorage for attachment of orthodontic appliances to facilitate orthodontic movement of teeth. They are temporary and removed after treatment. Single use only.
Material: Surgical stainless steel (ISO 5832-1) and Surgical titanium alloy (ISO 5832-3).
Sterility: Non-sterile. Steam sterilize before use.
Predicate Device: Leone Orthodontic Mini Implant (cleared 510(k) no. K071490).
Substantial Equivalence: The submission asserts that the Syntec orthodontic mini screws have the "same intended use" as the predicate and "equivalent performance characteristics," raising "no new issues of safety or effectiveness." The FDA concurred with this determination, clearing the device for market.

Summary

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510(k) SUMMARY

Submitter's name : Address :

す

K690476

510(K) SUMMARY

Syntec Scientific Corporation 2, Kung San Rd, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan. Telephone :886-4-7987099 Fax: 886-4-7987077

JUN 18 2009

Date the summary was prepared : April 25, 2008

Name of the device :	Syntec orthodontic mini screws
Trade or proprietary name :	Syntec orthodontic mini screws
Common or usual name :	Ortho Anchor Screws
Classification name :	Implants, Endosseous, Orthodontic
Prode Code :	OAT
Regulation No. :	872.3640
Class :	II

1. Description of the Device:

2. Indications for Use:

3.Substantial Equivalence :

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K090476

The Syntec orthodontic mini screws have same intended use as the Leone Orthodontic Mimi Implant from Leone SpA, 50 Via P. a Quaracchi Sesto, Fiorentino, IT-500 19, cleared 510 ( k ) no. K071490, and have equivalent performance characteristics.

Device Name	Syntec orthodontic mini screws	Leone orthodontic mini implant
Product code	OAT	OAT
Regulation no.	872.3640	872.3640
Applicant	Syntec Scientific Corporation (Taiwan)	Leone SpA ( Italy )
510 (k)	This Submission	K071490
Intended use	The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.	Provide a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily in the maxillary and mandibular bone and must be removed after orthodontic treatment has been completed.
Material	Surgical stainless steel ISO 5832-1Surgical titanium alloy ISO 5832-3	Surgical stainless steel ISO 5832-1
Sterility	Non-sterile. Steam sterilize before use.	Non-sterile. It is recommended to sterilize with steam autoclave before use.

4.Conclusion:

1 - 1

.***

The Syntec orthodontic mini screws raises no new issues of safety or effectiveness. The Syntec orthodontic mini screws does not additional concerns regarding safety and may therefore be considered substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

.HIN 18 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan Cheng Syntec Scientific Corporation 3F1. 96 Chung Hsiao E. Road Section 3 Taipei CHINA (TAIWAN) 106

Re: K090476

Trade/Device Name: Syntec Orthodontic Mini Screws Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: June 11, 2009 Received: June 16, 2009

Dear Ms. Cheng:

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.

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- Ms. Cheng

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 (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 go to http://www.fda.gov/AboutFDA/Centers Offices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runoe

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATION FOR USE

Indications for Use

510(k) Number (if known): Device Name: Syntec orthodontic mini screws Indications for Use: .

Kein Huluy for M.J.R
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K090476

Prescription Use AND/OR Over-The-Counter Use ( Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.