The SimpliClear Rectangular Orthodontic Wire is a translucent archwire comprised of glass fibers, a polymer composite resin, and a polymer coating. The embedded glass fibers function as the reinforcement, providing the necessary force to straighten teeth. The translucent polymer composite resin serves as the matrix, binding together the individual glass fibers. The outer coating, made of a USP Class VI polycrystalline and amorphous linear polymer, increases the abrasion resistance properties of the wire.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the SimpliClear Rectangular Orthodontic Wire, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric	Predicate Device Range (ORMCO NiTi & beta-Ti, BioMers Translucent Orthodontic Wire)	SimpliClear Rectangular Orthodontic Wire Performance (relative to predicate)
Material Properties	Elastic Modulus (tendency to be deformed elastically) Tested per ASTM D3916-02.	Established range (ORMCO NiTi & beta-Ti, BioMers Translucent Orthodontic Wire)	Greater than the established range. However, the document states: "do not raise safety or effectiveness issues as compared to the predicate devices" as higher values indicate a better ability to deform under load and recover to original state.
	Tensile Strength (maximum stress withstandable when stretched) Tested per ASTM D3916-02.	Established range (ORMCO NiTi & beta-Ti, BioMers Translucent Orthodontic Wire)	Within the established range.
	Flexural Strength (ability to resist deformation under load) Tested per ASTM D790-03.	Established range (ORMCO NiTi & beta-Ti)	Within the established range.
	Flexural Modulus (ratio of stress to strain in flexural deformation, tendency to bend) Tested per ASTM D790-03.	Established range (ORMCO NiTi & beta-Ti)	Within the established range.
Biocompatibility	Meets applicable requirements of ISO10993	Meets ISO10993	Meets the applicable requirements of ISO10993.
Intended Use	As an orthodontic archwire to provide force to the teeth to effect movement in orthodontic treatment (SimpliClear) / As an orthodontic arch wire used to provide force to the teeth to effect movement in the early (leveling and aligning) stage of orthodontic treatment (BioMers Translucent Orthodontic Wire) / Orthodontic arch wire (ORMCO)	Comparable	Intent for the SimpliClear Rectangular Orthodontic Wire is comparable to the predicate devices. "any differences in technological characteristics do not raise issues of safety and effectiveness."
Composition	Glass fibers with a polymer composite resin, and a polymer coating	BioMers Translucent Orthodontic Wire: Glass fibers with a polymer composite resin, and a polymer coating; ORMCO: Nickel Titanium, beta-Titanium and Stainless Steel	Substantially equivalent in terms of composition to the BioMers Translucent Orthodontic Wire. While different from Ormco (metal vs. polymer composite), substantial equivalence is claimed based on comparable mechanical properties and no new safety/effectiveness issues arising from the differences.

2. Sample Size and Data Provenance for the Test Set

The document does not specify a separate "test set" in the context of clinical data for algorithmic performance. Instead, the "testing" described is bench testing of physical properties of the orthodontic wires.

Sample Size for Bench Testing: Not explicitly stated in terms of the number of wires or samples tested for each metric (Elastic Modulus, Tensile Strength, Flexural Strength, Flexural Modulus). The text indicates "At similar wire dimensions" for comparisons, implying various dimensions were tested.
Data Provenance: The data comes from in-vitro bench testing performed according to specific ASTM standards (ASTM D3916-02 and ASTM D790-03). This is therefore not patient data, nor is it retrospective or prospective in the clinical sense.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

Not applicable. The ground truth for the "test set" (bench testing) is derived from objective physical measurements and adherence to recognized ASTM standards, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "test set" consists of physical property measurements against established ASTM standards, not interpretive data requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes the substantial equivalence of a physical medical device (orthodontic wire) based on its material composition and mechanical properties, compared to predicate devices. It does not involve AI or human readers evaluating cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not an AI/algorithm-based device.

7. Type of Ground Truth Used

The ground truth for the device's performance is based on objective physical measurements obtained through standardized laboratory tests (ASTM D3916-02 for Elastic Modulus and Tensile Strength, ASTM D790-03 for Flexural Strength and Flexural Modulus) and compliance with biocompatibility standards (ISO10993). Comparisons are then made to the performance ranges of legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

{0}------------------------------------------------

Sio Mers

We Make You Smile

510(k) Summary (per 21 CFR 807.92)

MAR 3 1 2001

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

George Aliphtiras, Vice President of Business Contact Person: Development Tel: (425) 487-3000 Fax: (425) 487-3813 Email: george(@biomersbraces.com

6 January 2011 Date Prepared:

II. Device Name

Proprietary Name:	SimpliClear Rectangular Orthodontic Wire
Common/ Usual Name:	Orthodontic wire
Classification Name:	Orthodontic plastic bracket
Regulation Number:	872.5470
Product Codes:	DYW, DZC
Classification:	II
Classification Panel:	Dental

III. Intended Use of the Device

The SimpliClear Rectangular Orthodontic Wire is indicated for use as an orthodontic archwire to provide force to the teeth to effect movement in orthodontic treatment.

IV. Description of the Device

Comparison to Predicate Device(s) V.

The SimpliClear Rectangular Orthodontic Wire is substantially equivalent in terms of composition to the BioMers Translucent Orthodontic Wire, and substantially equivalent in terms of mechanical properties to the Ormco Nickel Titanium, beta-Titanium and stainless steel rectangular wires. The

{1}------------------------------------------------

BioMers

We Make You Smilt

BioMers Translucent Orthodontic Wire was cleared by the FDA on May 2, 2008 under 510(k) K081143. The Ormco wires are exempt from 510(k) filings. .

	BioMers Products LLC	BioMers Products LLC	Ormco Corp.
Product Name	SimpliClear RectangularOrthodontic Wire	BioMers TranslucentOrthodontic Wire	Nickel Titanium (NiTi),beta-Titanium (beta-Ti)and Stainless Steel (SS)Rectangular OrthodonticWire
510(k) Number	Not assigned	K081143	Exempt
Intended Use	An orthodontic archwireused to provide force tothe teeth to effectmovement in orthodontictreatment.	An orthodontic arch wireused to provide force to theteeth to effect movement inthe early (leveling andaligning) stage oforthodontic treatment.	Orthodontic arch wire
MaterialComposition	Glass fibers with apolymer composite resin,and a polymer coating(same as K081143)	Glass fibers with a polymercomposite resin, and apolymer coating	Nickel Titanium, beta-Titanium and StainlessSteel
Biocompatibility	Meets the applicablerequirements of ISO10993	Meets the applicablerequirements of ISO10993	Meets the applicablerequirements of ISO10993
Performance TestingElastic ModulusA measurement of anobject or substance'stendency to bedeformed elastically(i.e., non-permanently)when a force is appliedto it. The elasticmodulus of an object isdefined as the slope ofits stress-strain curve inthe elastic deformationregion. Tested perASTM D3916-02.	At similar wire dimensions, the elastic modulus of the SimpliClear RectangularOrthodontic Wire is greater than the range established by the Ormco RectangularOrthodontic Wire made of NiTi and beta-Ti and that of the BioMers TranslucentOrthodontic Wire. However, as the Elastic Modulus refers to a material's ability toundergo elastic deformation, in other words the ability of the archwire to deform underan applied load and recover to its original state when the load is removed, the higher:values from the SimpliClear Rectangular Orthodontic Wire do not raise safety oreffectiveness issues as compared to the predicate devices.
Tensile StrengthThe maximum stressthat a material canwithstand while beingstretched or pulled.Tested per ASTMD3916-02.	At similar wire dimensions, the tensile strength of the SimpliClear RectangularOrthodontic Wire is within the range established by the Ormco Rectangular OrthodonticWire made of NiTi and beta-Ti and that of the BioMers Translucent Orthodontic Wire.
Flexural StrengthDefined as a material'sability to resistdeformation underload. Tested per ASTMD790-03.	At similar wire dimensions, the flexural strength of the SimpliClear RectangularOrthodontic Wire is within the range established by the Ormco Rectangular OrthodonticWire made of NiTi and beta-Ti.
	BioMers Products LLC	BioMers Products LLC	Ormco Corp.
Product Name	SimpliClear RectangularOrthodontic Wire	BioMers TranslucentOrthodontic Wire	Nickel Titanium (NiTi),beta-Titanium (beta-Ti)and Stainless Steel (SS)Rectangular OrthodonticWire
Flexural ModulusThe ratio of stress tostrain in flexuraldeformation, or thetendency for a materialto bend. Tested perASTM D790-03	At similar wire dimensions, the flexural modulus of the SimpliClear RectangularOrthodontic Wire is within the range established by the Ormco Rectangular OrthodonticWire made of NiTi and beta-Ti.

{2}------------------------------------------------

BioMers

We Make You Smile

VI. Conclusion

There are no known substantial differences in terms of composition and mechanical properties between the SimpliClear Rectangular Orthodontic Wire defined in this 510(k) submission and the BioMers Translucent Orthodontic Wire, and the Ormco Rectangular Wire composed of Nickel Titanium, beta-Titanium, and stainless steel, respectively. The intended uses are comparable and any differences in technological characteristics do not raise issues of safety and effectiveness. Therefore, the SimpliClear Rectangular Orthodontic Wire is substantially equivalent to BioMers Translucent Orthodontic Wire and the Ormoo Rectangular Wire.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Biomers Products, LLC C/O Mr. William Sammons Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

MAR 3 1 201

Re: K110796

Trade/Device Name: SimpliClear Rectangular Orthodontic Wire Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW, DZC Dated: March 16, 2011 Received: March 22, 2011

Dear Mr. Sammons:

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.

{4}------------------------------------------------

Page 2- Mr. Sammons

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/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/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 yours.

hm for

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

{5}------------------------------------------------

BioMers

We Make You Smile

4. Indication for Use Statement

510(k) Number (if known): 长\ ○ ヲタレ

Device Name:

SimpliClear Rectangular Orthodontic Wire

Indications for Use:

An orthodontic archwire used to provide force to the teeth to effect movement in orthodontic treatment.

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)

(Division Sign-Off)	Page 1 of ___
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number:	K110796

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.