The Translucent Orthodontic Bracket is comprised of single crystal alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placement of an arch wire which applies the necessary force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.

AI/ML Overview

The provided submission focuses on the substantial equivalence of the BioMers Translucent Orthodontic Bracket to predicate devices, primarily through comparison of technical characteristics and existing standards for dental materials. It does not contain information typically found in an AI/ML device submission regarding acceptance criteria for algorithm performance or detailed study designs for proving such criteria.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text as they pertain to AI/ML device testing methodologies not present here.

However, I can extract the acceptance criteria and performance data related to the device's material properties, which are relevant to its substantial equivalence claim.

Here's the available information based on the provided text:

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

The submission uses "Bond Strength" as a key performance metric for the BioMers Translucent Orthodontic Bracket, tested according to ISO 11405-2003(E). While explicit "acceptance criteria" in terms of a minimum or range for bond strength are not directly stated as a pass/fail threshold, the device's performance is compared against its predicates. The implication is that performance comparable to or better than predicate devices, within a clinically acceptable range, demonstrates safety and effectiveness.

Performance Metric	BioMers Translucent Orthodontic Bracket Performance (Mean ± SD)	Predicate 1: Absolute (Star Dentech Korea) Performance (Mean ± SD)	Predicate 2: PURE Sapphire (Ortho Technology) Performance (Mean ± SD)
Bond Strength	11.73 ± 3.04	5.51 ± 1.65	19.41 ± 5.08

Note: Units for bond strength are not explicitly stated in the table but are typically in MPa for this type of test.

Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):

The study primarily supporting the device's claims is a bench test and functional testing study conducted according to ISO 11405:2003 - Dental materials -- Testing of adhesion to tooth structure. This standard guides the methodology for evaluating the bond strength of dental materials to tooth structure.

Key Findings from the "Study":

The BioMers Translucent Orthodontic Bracket demonstrated a bond strength of 11.73 ± 3.04 (units not specified, but likely MPa).
This performance falls within the range observed for the predicate devices, being higher than one predicate (Absolute: 5.51 ± 1.65) though lower than the other (PURE Sapphire: 19.41 ± 5.08). The submission implicitly argues that this performance, combined with similar technological characteristics and adherence to safety standards (ISO 10993 for biocompatibility, ISO 14971 for risk analysis), establishes substantial equivalence.

Regarding AI/ML-specific questions (2-9):

The provided text does not contain any information related to AI/ML device performance, ground truth establishment, expert review, sample sizes for AI/ML models, or MRMC studies. The device in question is a physical orthodontic bracket, and the submission focuses on its material properties and comparison to existing physical devices, not an AI/ML algorithm. Therefore, the following sections cannot be populated:

Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

Summary

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BioMers

K101481

We Make You Smile

JUN 2 3 2010

10/3

510(k) Summary (per 21 CFR 807.92)

(per 21 CFR 807.92)

Applicant I. BioMers Products LLC. 18912 North Creek Parkway, Suite 210 Bothell, WA, 98011,

George Aliphtiras, Vice President of Business Contact Person: Development

Tel: 425-487-3000 Fax: 425-487-3813 Email: george@biomersbraces.com

March 15, 2010 Date Prepared:

II. Device Name

BioMers Translucent Orthodontic Bracket Proprietary Name: Orthodontic Plastic Bracket Common/ Usual Name: Orthodontic appliance and accessories Classification Name: 872.5470 Regulation Number: NJM Product Codes: Classification: II Classification Panel: Dental

III. Predicate Device

The BioMers Translucent Orthodontic Bracket is substantially equivalent to the Absolute bracket from Star Dentech Korea, Corp. and the PURE Sapphire bracket from Ortho Technology. The Absolute bracket was most recently cleared by the FDA on May 27, 2009 under 510(k) K090567. The PURE Sapphire bracket was cleared by the FDA on December 18, 2007 under 510(k) K073045.

Intended Use of the Device IV.

The Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

V. Description of the Device

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K101481

BioMers

We Make You Smile

force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.

VI. Summary of the Technical Characteristics

The BioMers Orthodontic Bracket was designed and tested using ISO 11405:2003 - Dental materials -- Testing of adhesion to tooth structure

The BioMers Translucent Orthodontic Bracket has similar technological characteristics as the predicate devices: Absolute bracket (Star Dentech Korea, Corp.) and PURE Sapphire bracket (Ortho Technology).

	BioMers Products	Star Dentech Korea	Ortho Technology
Product Name	BioMers TranslucentOrthodontic Bracket	Absolute	PURE Sapphire
510(k) Number	Not assigned	K090567	K073045
Product Code(s)	NJM	NJM	NJM
Regulation #	872.5470	872.5470	872.5470
Class	II	II	II
Intended Use	Indicated fororthodontic movementof natural teeth,excluding mandibularbicuspid teeth.	Indicated fororthodontic movementof natural teeth,excluding mandibularbicuspid teeth.	Indicated fororthodontic movementof natural teeth,excluding mandibularbicuspid teeth.
MaterialComposition	Al2O3 (single crystalalumina)	Al2O3 (single crystalalumina)	Al2O3 (single crystalalumina)
Translucent	Yes	Yes	Yes
Standards	ISO 11405:2003 -Dental materials --Testing of adhesion totooth structure	Not known	Not known
Bracket Design	Twin bracket	Twin bracket	Twin bracket
Biocompatibility	Meets the applicablerequirements of ISO10993	Meets the applicablerequirements of ISO10993	Meets the applicablerequirements of ISO10993
Available SlotSizes	0.018", 0.022"	0.018", 0.022"	0.018", 0.022"
AvailablePrescriptions	Standard-Edgewise,Roth & High Torque	Roth & High Torque	Standard-Edgewise,Roth& High Torque
Bond Strength*	$11.73 \pm 3.04$	$5.51 \pm 1.65$	$19.41 \pm 5.08$

*Bond strength testing was carried out according to ISO 11405-2003(E).

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K101481

BioMers

We Make You Smile

VII. Safety & Effectiveness

The Translucent Orthodontic Bracket has the same intended use and similar technological characteristics as the predicate devices. The differences in technological characteristics between the new device and the predicate device do not raise issues of safety and effectiveness of the Translucent Orthodontic Bracket. Bench tests and functional testing studies, according to ISO 11405:2003 - Dental materials -- Testing of adhesion to tooth structure were conducted. The risk analysis was conducted according to ISO 14971:2007. Applicable biocompatibility testing was in accordance to the requirements of ISO 10993-1.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract representation of a bird or a human figure with outstretched arms.

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

BioMers Products, LLC C/O Ms. Paula Wilkerson Intertek Testing, Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

JUN 2 3 2010

Re: K101481

Trade/Device Name: BioMers Translucent Orthodontic Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: June 11, 2010 Received: June 14, 2010

Dear Ms. Wilkerson:

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- Ms. Wilkerson

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.html 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Tanner

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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1061

BioMers

R10170

We Make You Smile

4. Indication for Use Statement

510(k) Number (if known):

BioMers Translucent Orthodontic Bracket

Indications for Use:

Device Name:

The Translucent Orthodontic Bracket is indicated for orthodontic movement of . natural teeth, excluding mandibular bicuspid teeth.
Ken Huley for MSE

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K101481

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Page 1 of 1

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.