Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

Device Description

The OBS/Biokey Anchorage Screw, consisting of stainless steel (SUS-316LVM) and titanium alloy (Ti-6Al-4V ELI), is a self-tapping screw with various sizes for applications in the orthodontic field. It is intended to serve as a fixed anchorage point for the attachment of orthodontic and pre-prosthetic appliances, in order to facilitate the orthodontic movement of teeth. The OBS/Biokey Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use. The devices are used temporarily with the intention to be removed after orthodontic treatment. The average temporary implantation period for the anchorage screw is six months. Screws are intended for single-use only.

The purpose of this submission is to implement six additional specification models: BM, AT, AY, CH, FH, and HH. The BD model was previously cleared under K152297.

The intended use, materials, manufacturing process, and sterilization method of the OBS/Biokey Anchorage Screw for BD, BM, AT, AY,CH, FH, and HH are the same. The differences are the type and dimensions (diameter and length). Different kinds of OBS/Biokey Anchorage Screw are manufactured to meet market needs. The BD model is available in diameters of 1.5. 2mm and lengths of 6. 8. 10. 12. 14mm. The BM and AT models are available in diameters of 1.6, 2mm and lengths of 6, 8, 10, 12, 14mm. The AY model is available in diameter of 1.4mm and lengths of 6, 8, 10mm. The CH, FH, and HH models are available in diameters of 1.4, 1.6, 2mm and lengths of 6, 8, 10, 12, 14mm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the OBS Anchorage Screw/Biokey Anchorage Screw. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new medical device is safe and effective through extensive clinical trials for unique claims.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria for an AI/clinical diagnostic (e.g., ground truth establishment with experts, MRMC studies, training set details) are not applicable to this 510(k) submission for an orthodontic anchorage screw.

The "acceptance criteria" and "study" in this context refer to the engineering and material performance tests demonstrating that the modified device maintains the same safety and effectiveness as its predicate, despite minor dimensional and design variations.

Here's a breakdown of the requested information based on the provided text, indicating what is present and what is not applicable:

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

The document does not provide a direct table of specific numerical acceptance criteria and reported performance values for each test. Instead, it states that the tests were performed "in accordance to" specific ISO and ASTM standards, and that the results "indicate that the OBS/Biokey Anchorage Screw met acceptance criteria and is substantially equivalent to the predicate device."

Acceptance Criteria (Implicitly based on standards):
- Biocompatibility: Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization and Irritation), ISO 10993-11 (Systemic Toxicity).
- Sterilization Validation: Compliance with ISO 11737-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, and AAMI/ANSI ST79 for steam sterilization.
- Mechanical Performance: Compliance with ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws).
Reported Device Performance: The document states that the test results "met acceptance criteria" and demonstrated "substantial equivalence" to the predicate device. Specific numerical results are not detailed in this summary.

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

Sample Size: Not explicitly stated for each test in the provided summary. Performance testing is generally conducted on a sufficient number of samples to demonstrate statistical significance or compliance with the specified standards.
Data Provenance: The tests are non-clinical (laboratory/bench testing) and were performed to support this specific regulatory submission for the device manufactured by BOMEI CO., LTD. (Taiwan). The data is retrospective in the sense that the tests were completed prior to submitting the 510(k).

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

Not Applicable. This is a mechanical/material performance and sterility validation study, not a clinical study involving human interpretation of medical data. The "ground truth" for these tests is defined by the established parameters and methodologies within the cited international standards (ISO, ASTM, AAMI/ANSI). Experts in fields such as materials science, biomechanical engineering, and microbiology are involved in defining and conducting such tests, but their role is not to "establish ground truth" in the way human readers would for an imaging AI.

4. Adjudication method for the test set

Not Applicable. As this is non-clinical bench testing, there is no need for adjudication in the context of human reader disagreement, as would be the case in an AI/clinical diagnostic study. The "adjudication" is inherent in the standardized test procedures and interpretation of results against the specified criteria.

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

No. This is a medical device for providing anchorage in orthodontics, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.

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

No. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Reference Standards/Physical Measurements: The "ground truth" for this device's performance is established by adherence to and measurements against the specified properties and performance requirements outlined in the cited international standards (ISO 10993 series for biocompatibility, ISO 11737 series, ISO 17665 series, and AAMI/ANSI ST79 for sterilization, and ASTM F543 for mechanical performance). These involve laboratory measurements, assays, and biological testing, not expert consensus on medical images or pathology.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that requires a training set.

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

Not Applicable. As per point 8.

Summary

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

Bomei Co., Ltd. % Chih-Hao Kao General Manager Voler Biotech Consulting Co., Ltd. No. 3-1, Ln. 58, Hejiang St., Zhongshan Dist., Taipei City 10480 TAIWAN

Re: K202278

Trade/Device Name: OBS Anchorage Screw, Biokey Anchorage Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: December 2, 2020 Received: December 11, 2020

Dear Chih-Hao Kao:

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.

Andrew Steen Assistant 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) K202278

Device Name

OBS Anchorage Screw, Biokey Anchorage Screw

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

OBS Anchorage Screw/Biokey Anchorage Screw

1. Submitter

(a) Contact person

Name: Howard Kao Title: General Manager E-mail: leon.howard01@gmail.com Office address: 4F, No. 1492-2, Chunrih Rd., Taoyuan Dist., Taoyuan City, 33051, TAIWAN Tel: (O) +886-933-872-972 Date prepared: January 6, 2021

Manufacturer information (b)

Submitter name:	BOMEI CO., LTD.
Submitter address:	4F, No. 1492-2, Chunrih Rd., Taoyuan Dist.,Taoyuan City, 33051, TAIWAN
Submitter phone number:	+886-3-355-4989
Submitter fax number:	+886-3-346-0897

2. Device Name and Classification

Product Name:	OBS Anchorage Screw, Biokey Anchorage Screw
Classification Name:	Implant, Endosseous, Orthodontic
Common or Usual Name:	Endosseous dental implant
Classification Panel:	Dental
Regulation Number:	21 CFR 872.3640
Device Class:	Class 2
Product Code:	OAT

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3. Predicate Device(s)

K152297 OBS Anchorage Screw

4. Device Description

The purpose of this submission is to implement six additional specification models: BM, AT, AY, CH, FH, and HH. The BD model was previously cleared under K152297.

5. Indications for Use

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6. Comparison of technological characteristics with the predicate device

We compared the modified device with the existing device (K152297) in the Comparison Table below.

DeviceName	OBS Anchorage Screw(Existing)	OBS Anchorage Screw/Biokey AnchorageScrew(Modified)	Comparison
Applicant	BOMEI	BOMEI	Identical
510(k) Number	K152297	K202278	-
Regulation No.	21 CFR 872.3640	21 CFR 872.3640	Identical
Product Code	OAT	OAT	Identical
Trade Name	OBS Anchorage Screw	OBS Anchorage ScrewBiokey Anchorage Screw	DifferentAdd new trade name
Material	Stainless Steel (ISO 5832-1:2007 /ASTM F138-13)Titanium Alloy (ISO 5832-3:1996 / ASTMF136-13)	Stainless Steel (ISO 5832-1:2007 /ASTM F138-13)Titanium Alloy (ISO 5832-3:1996 / ASTMF136-13)	Identical
DeviceName	OBS Anchorage Screw(Existing)	OBS Anchorage Screw/Biokey AnchorageScrew(Modified)	Comparison
IntendedUse	Temporary anchorage screws are intended toprovide a fixed anchorage point forattachment of orthodontic appliances tofacilitate the orthodontic movement of theteeth.It is used temporarily and is removed afterorthodontic treatment has been completed.	Temporary anchorage screws are intended toprovide a fixed anchorage point forattachment of orthodontic appliances tofacilitate the orthodontic movement of theteeth.It is used temporarily and is removed afterorthodontic treatment has been completed.	Identical
Model	BD	BD, BM, AT, AY, CH, FH, HH	DifferentAdd new six specifications
Sterility	Supplied non-sterile; steam sterilize beforeuse	Supplied non-sterile; steam sterilize beforeuse	Identical
Type	Square collar, Mushroomhead, None/Round/Slot hole(BD)	Square collar, Mushroomhead, None/Round/Slot hole(BD)Hexagonal collar, Mushroomhead, None/Round/Slot hole(BM)Hexagonal collar, Oval head,None/Round/Slot hole (AT)Hexagonal collar, Slight head,None/Round hole (AY)	Different
		Cap head, None/Round/Slothole (CH)Flat head, None/Round/Slothole (FH)Hook head, None/Round/Slothole (HH)
Length (mm)	8, 10, 12, 14	6, 8, 10, 12, 14	DifferentAdd length of 6mm
Diameter (mm)	1.5, 2	1.4, 1.5, 1.6, 2	DifferentAdd diameters of 1.4mm,1.6mm

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DeviceName	OBS Anchorage Screw(Existing)	OBS Anchorage Screw/Biokey AnchorageScrew(Modified)	Comparison
Non-threadregion(mm)	0mm	0, 2, 4mm	DifferentAdd non-thread regionlengths of 2mm, 4mm(except AY)In the non-thread region,there is no pitch on thescrew.
Energy sources	Non-active implantable devices	Non-active implantable devices	Identical
Where used	Dental practices	Dental practices	Identical
Targetpopulation	Professional use only - qualified dentistsStrictly reserved to specialized and trainedusers.	Professional use only - qualified dentistsStrictly reserved to specialized and trainedusers.	Identical

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DeviceName	OBS Anchorage Screw(Existing)	OBS Anchorage Screw/Biokey AnchorageScrew(Modified)	Comparison
Biocomp.Testing	ISO 10993-5ISO 10993-10ISO 10993-11	ISO 10993-5ISO 10993-10ISO 10993-11	Identical
SterilizationValidationTesting	ISO 11737-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, AAMI/ANSI ST79for steam sterilization	ISO 11737-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, AAMI/ANSI ST79for steam sterilization	Identical
MechanicalPerformanceTesting	ASTM F543	ASTM F543	Identical

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DeviceName	OBS Anchorage Screw(Existing)	OBS Anchorage Screw/Biokey AnchorageScrew(Modified)	Comparison
----------------	-----------------------------------	-------------------------------------------------------------	------------

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7. Performance data

Non-clinical performance testing
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing in accordance to ISO 10993-5, ISO 10993-10, and ISO 10993-11 and referenced from K152297:
- Cytotoxicity: ISO 10993-5 Biological evaluation of medical . devices - Part 5: Tests for In Vitro cytotoxicity
- Sensitization and Irritation: ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- . Systemic toxicity: ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Sterilization validating testing in accordance to ISO 11737-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, and AAMI/ANSI ST79 for steam sterilization and referenced from K152297:
- · ISO 11737-1 Sterilization of medical devices Microbiological Methods Part 1: Determination of the population of microorganisms on product, 2ed
- ISO 11737-2 Sterilization of medical devices Microbiological Methods Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process
- ISO 17665-1 Sterilization of health care products -- Moist Heat --Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
- ISO 17665-2 Sterilization Of Health Care Products Moist Heat -Part 2: Guidance On The Application Of ISO 17665-1
- AAMI/ANSI ST79 Comprehensive Guide to Steam Sterilization . and Sterility Assurance in Health Care Facilities
�� Mechanical Performance Testing has been performed with the predicate devices in accordance to ASTM F543 used comparatively to demonstrate VOL004_8

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substantial equivalence.

· ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws
Animal Studies .
- ・ None
Clinical Studies .
- None .

The results of this testing indicate that the OBS/Biokey Anchorage Screw met acceptance criteria and is substantially equivalent to the predicate device.

8. Conclusions

In comparison to the legally marketed device, the OBS/Biokey Anchorage Screw has the same intended use, materials, manufacturing process, and sterilization method. The differences between the subject device and the predicate device are the type and dimensions (diameter and length).

However, testing data such as mechanical performance testing provided in the submission show that these differences do not raise issues in performance. Based on the information provided in this premarket notification, BOMEI concludes that the OBS/Biokey Anchorage Screw is substantially equivalent to the predicate device.

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.