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 screws are manufactured from commercially SUS316L (stainless steel) and Ti6AL-4V (Titanium alloy). The screws are available with thread diameter are 1.5mm and 2.0 mm, and total thread lengths is 7.0mm. The minor technological modification for Mico One Orthodontic Screw is designed for easy insertion and removal. The design of smooth curve surface of screw head is comfortable to patient and the screws with or without a 0.7mm/0.8mm diameter hole can supply different orthodontic methods for orthodontists.

AI/ML Overview

This document is a 510(k) summary for a medical device called "Mico One Orthodontic Screw". It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your requested information:

This document does NOT describe the acceptance criteria and a study proving a digital device meets acceptance criteria. Instead, it describes acceptance criteria and testing for a physical medical device (an orthodontic screw).

Therefore, many of your requested points, especially those related to AI/algorithm performance, ground truth establishment, expert adjudication, and training/test set sizes for digital devices, are not applicable to this submission.

However, I can extract the relevant information for the physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical targets and corresponding reported performance values for each criterion. Instead, it refers to industry standards and general performance categories.

Acceptance Criteria Category	Reported Device Performance (as described)
Mechanical Performance	- ASTM F543 Standard: The device's mechanical function (Shear Bond Strength, Torque Strength test, and structure integrity) was tested and demonstrated to fulfill design specifications.
	- Reliability: Mechanical performance tests confirmed the device's reliability for its intended function during use.
Biocompatibility	- Adherence to Standards: Evaluation and testing conducted in accordance with FDA-recognized ISO 10993 series standards (10993-1, 10993-3, 10993-5, 10993-6, 10993-10, 10993-11, 10993-12).
Sterilization Validation	- Adherence to Standard: Moist Heat sterilization validation conducted in accordance with ISO 17665-1.
Dimensional Conformance	- Predicate Range: Diameter (1.5mm, 2.0mm) and length (7mm) are included within the range of the predicate device.

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

The document does not specify the sample size for the mechanical performance or biocompatibility testing. It also does not explicitly state the provenance of the data (e.g., country of origin). Since these are bench tests, "retrospective" or "prospective" as typically applied to clinical data don't fully apply, but they would be controlled laboratory studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as this is testing for a physical device, not a digital device requiring human expert ground truth for interpretation. Mechanical and biocompatibility tests rely on standardized measurement methods and laboratory analysis.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting medical images or clinical data, which is not relevant to the physical device testing described.

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

This section is not applicable as this document pertains to a physical orthodontic screw, not an AI or digital device designed to assist human readers.

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

This section is not applicable as this document pertains to a physical orthodontic screw, not an algorithm.

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

For the mechanical performance, the "ground truth" is established by the specifications defined in the ASTM F543 standard. For biocompatibility, the "ground truth" is determined by the Pass/Fail criteria outlined in the ISO 10993 series of standards.

8. The sample size for the training set

This section is not applicable as this document describes testing for a physical device, not an AI or machine learning model that requires a training set.

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

This section is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Ze Fang Technology Co., Ltd. % Anita Chen Advisor ZhengCheng Consulting Limited Company No.19, 335 Lane, Fu-Xi Road, Shulin District New Taipei City, 238 TAIWAN

Re: K202163

Trade/Device Name: Mico One Orthodontic Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: September 2, 2022 Received: Septemeber 14, 2022

Dear Anita Chen:

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 (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.

Andrew I. 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K202163

Device Name

Mico One Orthodontic Screw

Indications for Use (Describe)

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to re instructions, search existing data sources, gather and maintain the data needed and complete and re the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." PSC Publishing Services (301) 443-6740 FORM FDA 3881 (6/20) EF

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510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92

1.	Submitter
	Manufacturer	Ze Fang Technology Co., Ltd.
	Mailing Address	1F, No. 17, Alley 81, Lane 2, Zhongxing Rd.,Sec. 1, Dali Dist., Taichung City, Taiwan (R.O.C.)Establishment Registration No.:3013689189
	Contact Person	Mrs. Anita Chen/ Regulatory Adviser of Ze FangTechnology Co., Ltd.
	Phone:	+886(0) 939-855-759
	E-mail:	m9104303@gmail.com
	Date Prepared	October 7, 2022
2	Device Name
	Proprietary Name:	Mico One Orthodontic Screw
	Common or usual name	Orthodontic screw
	Product Code	OAT
	Device	Orthodontic screw
	CFR Classification	CFR Part 872.3640
	Device Class	II
	Classification Panel	Dental
3	Primary Predicate	K142001
	Trade or proprietary ormodel name:	Syntec Wetali Orthodontic Mini Screws
	Manufacturer:	Syntec Scientific CorporationNo.2, Kung San RoadChuan Shing Industrial Zone,Shen Kang, Chang Hua Hsien, Taiwan R.O.C
	Reference Device:	K042345
	Trade or proprietary or	LIN/LIOU ORTHODONTIC MINI ANCHOR
	model name:	SYSTEM(LOMAS)
	Manufacturer:	Mondeal Medical Systems GmbHAmstel 320-1 1017AP Amsterdam TheNetherlands
4	Device Description:	The screws are manufactured from commerciallySUS316L (stainless steel) and Ti6AL-4V(Titanium alloy). The screws are available withthread diameter are 1.5mm and 2.0 mm, and totalthread lengths is 7.0mm. The minor technologicalmodification forMico One Orthodontic Screw is designed foreasy insertion and removal. The design of smoothcurve surface of screw head is comfortable topatient and the screws with or without a0.7mm/0.8mm diameter hole can supply differentorthodontic methods for orthodontists.
5.	Intended Use:	Mico One Orthodontic Screw is indicated for use as afixed anchorage point for attachment of orthodonticappliances to facilitate the orthodontic movement ofteeth. It is used temporarily and is removed afterorthodontic treatment has been completed. Screwsare intended for single use only.
	Special Conditions forUse Statement(s):	For orthodontic patient only
6.	TechnologicalCharacteristics andSubstantial EquivalenceComparison withPredicate:	A comparison of the device features, intendeduse, and otherinformation demonstrates that the Mico OneOrthodontic Screw is substantially equivalent tothe predicate device as summarized in Table 1.The differences raise no new question of safetyand effectiveness.

The assigned 510(k) Number: K202163

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Table 1

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510(K)Number	K202163	K142001	K042345
DeviceName	Mico One OrthodonticScrew	Syntec WetaliOrthodontic MiniScrews	Lin/Liou OrthodonticMini Anchor System(Lomas)
Manufacturer	Ze Fang TechnologyCo., Ltd.	Syntec ScientificCorporation	Mondeal MedicalSystems GmbH
Headstructure	Hexagon mushroomhead,Four-corner mushroomhead, Tetragonalmushroom head, Four-corner mushroom headhalf thread type,Four-corner headless,Hexagonal wing head,Hexagon HOOK headtype, Round cross-shaped groove,Hexagonal hole typeabove the round head,Small hexagonmushroom head	Four-cornermushroom head,Tetragonalmushroom head,Four cornerHOOK head type,Hexagonmushroom head,Small hexagonalmushroom head,Short four-corneredmushroom head	Four-corner cross-section, Four cornerHOOK head type,Four-corner winghead
BodyDiameter(D)	Ø 1.5mm, Ø 2.0mm	From 1.4mm to2.0mm	From 1.5mm to2.0mm
Length(mm)	7mm	From 5.0mm to17.0mm	From7mm to 11mm
Material ofFixture	SUS316L (stainlesssteel) ASTM-F138,Ti6Al-4V ASTM-F136	SUS316L(stainless steel),Ti6Al-4V	Ti6AL-4V

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Shelf life	2 years	15 years	NA
Indication for use	Mico One 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	The screws are indicated for use as a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. They are used temporarily and are removed after orthodontic treatment has been completed. They are intended for single use only.	The Lin/Liou Orthodontic Mini Anchor System (LOMAS) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only

A minor technological difference between the predicate device and subject device is one piece assembled with main device and 3 components of Mico One Orthodontic Screw. But both of us used the same technological design for ligating. Bench testing

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demonstrates that Mico One Orthodontic Screw can successfully remove the tooth to maintain the position. And the diameter and length are included in the range of the predicate device. Although there is a slightly different technological design, as compared to the predicate, the performance data demonstrates the proposed device performs in a similar manner as the predicate device. Therefore, we believe Orthodontic screw is "Substantially Equivalent" to the predicate devices.

7. Performance Testing

Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device.

. ASTM F543-Standard Specification and Test Methods for Metallic Medical Bone Screws
Mico One Orthodontic Screw's mechanical function including Shear Bond Strength, Torque Strength test and structure integrity were tested and demonstrated that the design specification from design input are fulfilled. Mechanical performance tests were also conducted to demonstrate the reliability of the device for the intended function during use.

Biocompatibility testing

The biocompatibility evaluation and testing of the Mico One Orthodontic Screw was conducted in accordance with the following standards and guidance, as recognized by the FDA:

. FDA Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing", 2020.
. ISO 10993-3,Biological evaluation of medical device-Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity.
. ISO 10993-5, Biological evaluation of medical device-Part 5: Tests for in vitro cytotoxicity.
. ISO 10993-6, Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation.
ISO 10993-10, Biological evaluation of medical device-Part 10: Tests for . irritation and skin sensitization.

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. ISO 10993-11, Biological evaluation of medical device-Part 11: Tests for systemic toxicity.
. ISO 10993-12, Biological evaluation of medical device-Part 12: Sample preparation and reference materials.

Sterilization Validation

Device is provided in non-Sterile but user will sterilized before use. Moist Heat sterilization validation was conducted in accordance with ISO 17665-1.

No animal studies or clinical testing have been required for these devices.

1. Conclusion
  Based on the intended use and/or indications for use, technological characteristics, performance testing and comparison to the predicate device, the Mico One Orthodontic Screw is substantially equivalent.

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.