Symetri Clear, is a single-use orthodontic bracket made from polycrystalline alumina. This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. To aid with visual placement of the bracket to the tooth surface, the bracket has a removable, color coded, plastic axis indicator that is lifted away from the bracket following tooth placement or temporary color coded labial tie wings that are removed with a toothbrush and water. To identify tooth designation, the brackets include a temporary ink dot that is removed with a toothbrush and water after the brackets have been placed on the tooth. After the brackets are placed, an archwire is then inserted / threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Symetri Clear Debonding Instrument / Pliers. This step is also known as debonding.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the Symetri Clear orthodontic bracket. This type of submission focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices, rather than comprehensive clinical performance studies typical for novel medical devices.

Therefore, the document does not contain information about acceptance criteria and the study that proves the device meets those criteria in the context of typical AI/ML device evaluations. Instead, it describes non-clinical performance data to demonstrate equivalence.

Here's an analysis of what is provided, and what is missing based on your requested information:

Key Takeaways from the document:

Device Type: The Symetri Clear is an orthodontic bracket made from polycrystalline alumina, intended for the orthodontic movement of teeth. It is a physical medical device, not a software/AI device.
Regulatory Pathway: 510(k) Pre-Market Notification, demonstrating substantial equivalence to predicate devices (3M Unitek Corporation's Clarity™ ADVANCED Ceramic Brackets (K102803) and Damon™ 4Clear (K081415)).
Performance Data: The submission relies on non-clinical performance data and biocompatibility assessments to establish substantial equivalence. No clinical performance data was performed or submitted for Symetri Clear.
No AI/ML Component: There is no indication that the Symetri Clear device itself or its use involves any Artificial Intelligence or Machine Learning component.

Addressing your specific questions based on the provided document:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail numeric thresholds in the document. The general acceptance criterion implied is "perform comparably to the predicate devices" for various non-clinical tests.
- Reported Device Performance: The document states: "The testing analysis shows that Symetri Clear brackets perform comparably to the predicate devices." Specific numerical results for each test (Torque Strength, Double Tie Wing Strength, Bond Strength Shear, Bond Strength Tensile, Wire Drag, Debonding Removal Fracture, Hook Strength, Staining) are not included in this summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this document for the non-clinical tests.
- Data Provenance: Not specified. It's non-clinical lab testing.
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. This is a physical device submission demonstrating mechanical and material properties. There is no "ground truth" in the diagnostic sense, nor is there a panel of experts evaluating diagnostic performance. The "ground truth" would be the standard scientific methods and measurements for the physical properties being tested.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 not an AI-assisted device. No MRMC study was conducted or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable/Implied: For non-clinical tests, the "ground truth" is defined by the standardized measurement methodologies (e.g., ISO 27020 for dimensions) and the results obtained from those methodologies. It's not a diagnostic "ground truth."
The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established
- Not Applicable. See point 8.

In summary, the provided document is a regulatory submission for a traditional, physical medical device (an orthodontic bracket) and details non-clinical performance testing to demonstrate substantial equivalence to predicate devices, not an AI/ML device with associated acceptance criteria, ground truth, or clinical study designs typically associated with your questions.

Summary

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January 31, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Ormco Corporation Ms. Tara Bonny Senior Regulatory Affairs Specialist 1717 W. Collins Avenue Orange, California 92867

Re: K172845

Trade/Device Name: Symetri Clear Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: December 20, 2017 Received: December 22, 2017

Dear Tara Bonny:

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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Mary S. Runner -S

forTina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172845

Device Name

Symetri™ Clear

Indications for Use (Describe)

This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "Ormco" in a bold, sans-serif font. The word is a dark blue color. There is a trademark symbol to the right of the word.

510(k) SUMMARY K172845

This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.

1.	510(k) Submitter................................	Ormco Corporation1717 W. Collins AvenueOrange, California 92867
2.	Contact................................	Tara BonnyRegulatory AffairsPhone: 909-962-5856Fax: 909-962-5694Email: Tara.Bonny@kavokerr.com
3.	Additional Contact................................	Valerie A. CimmarustiVice President,Regulatory Affairs & Design Assurance (RADA)Phone: 714-516--7476Fax: 909-962-5694Email: Valerie.Cimmarusti@kavokerr.com
4.	Date Prepared................................	January 2, 2018
5.	Device
	Proprietary Name................................	Symetri™ ClearComponent of: Symetri™ Straight-Wire™ System
	Classification Name................................	Bracket, Ceramic Dental
	Regulation Number................................	21 CFR 872.5470
	Product Code................................	NJM
	Medical Specialty Panel................................	Dental
	Classification................................	Medical Device, Class II

Predicate Device 6.

Symetri Clear™ is substantially equivalent to 3M Unitek Corporation's Clarity™ ADVANCED Ceramic Brackets (K102803) cleared on February 17, 2011, product code NJM.

7. Reference Predicate Device

Damon™ 4Clear, K081415

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8. Device Description

The Symetri Clear Debonding Instruments / Plier was included for informational purposes only, not for review for clearance.

9. Indications for Use

This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed.

Although Symetri Clear's Indications for Use statement is not identical to the predicate devices, the minor differences in phrasing do not change the intended use.

10. Comparison of Technology

Symetri Clear is a non self-ligating, single-use orthodontic bracket's design has one-piece base and bracket construction, and is made from translucent alumina. To provide optional bond strength and effective bracket debonding, the base has a laseretched pattern. To ensure accurate placement, it uses a removable plastic component that is inserted into the horizontal and vertical slots of the bracket or temporary color which is incorporated into the labial surface instead of the plastic indicator. A temporary ink dot facilitates tooth designation. All ink is removed after the bracket has been placed on the tooth. The bracket is designed to remain intact during debonding.

As with Symetri Clear, the predicate device. Clarity ADVANCED, is also a non selfligating, single-use orthodontic bracket which has a one-piece base and bracket construction, and is made from translucent alumina. It also includes a temporary ink dot to facilitate tooth designation but does not include a removable plastic indicator for bracket placement. Bracket placement is achieved via temporary horizontal and vertical colored ink markers. Like Symetri Clear, all ink is removed after the bracket has been placed on the tooth. It also differs from Symetri Clear in its bracket base; it is a glassgrit, mechanical-locking base with a stress concentrator for predicable squeeze debonding. The stress concentrator on the base, causes the bracket to collapse during debonding by design.

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The reference predicate, Damon Clear2 (K081415), is also a single-use orthodontic bracket, with a one-piece base and bracket construction, and is made from translucent alumina. Similar to Symetri Clear, it utilizes a removable plastic indicator for tooth placement and a temporary ink dot for tooth designation. Unlike Symetri Clear and Clarity ADVANCED, this bracket is self-ligating.

Clarity ADVANCED (K102803), Damon Clear / Damon Clear2 (K081415) and Symetri Clear bracket systems (K172845), all offer a hand instrument accessory designed for bracket debonding. While the debonding process is not identical, these variations do not change the indications for use.

Symetri Clear shares the same indications for use as the primary and reference predicate devices. Differences between the devices do not raise any questions of safety and effectiveness.

11. Non-Clinical Performance Data

Non-clinical performance data included testing results for Torque Strength (also known as Wire Torque), Double Tie Wing Strength, Bond Strength Shear (also known as Shear Test), Bond Strength Tensile (also known as Tensile Strength), Wire Drag, Debonding Removal Fracture (also known as Bracket Removal Fracture), Hook Strength and Staining. The testing analysis shows that Symetri Clear brackets perform comparably to the predicate devices.

Metal Ligation and Double Tie bench testing was also conducted, however, not compared to a predicate.

Biocompatibility assessment and testing was performed using standard risk assessment techniques and in consideration of FDA and internationally recognized guidance's.

Symetri Clear brackets were inspected and met the dimensions itemized in ISO 27020. Dentistry - Brackets and tubes for use in orthodontics.

Element	Clarity™ ADVANCED(K102803)	Damon Clear /Damon Clear2(K081415)	Symetri™ Clear(K172845)
510(k)	K102803	K081415	K172845
Trade Name	Clarity ADVANCEDCeramic Brackets	Damon Clear /Damon Clear2	Symetri Clear
Target Users	Licensed Orthodontic /Dental Professionals	Licensed Orthodontic /Dental Professionals	Licensed Orthodontic /Dental Professionals
DeviceDescription	Clarity ADVANCED isa single-usepolycrystalline alumina	Damon Clear / DamonClear2 is a single-usepolycrystalline alumina	Symetri Clear is asingle-usepolycrystalline alumina
Element	Clarity™ ADVANCED(K102803)	Damon Clear /Damon Clear2(K081415)	Symetri™ Clear(K172845)
	orthodontic twinbracket.	orthodontic self-ligatingbracket.	orthodontic twinbracket.
Indications forUse(Identical to 510k)	Clarity ADVANCEDCeramic Brackets areintended for use inorthodontic treatment.The brackets are affixedto teeth so that pressurecan be exerted on theteeth.	Damon 4Clear* is abracket system intendedto aid in the movementof patient teeth duringorthodontic treatment.* Name at time of submission.	This device is intendedfor the orthodonticmovement of teeth. It isused temporarily and isremoved afterOrthodontic treatmenthas been completed.
Common Name	Orthodontic CeramicBracket	Orthodontic CeramicBracket	Orthodontic CeramicBracket
ClassificationName	Bracket, Ceramic,Dental	Bracket, Ceramic,Dental	Bracket, Ceramic,Dental
Class	II	II	II
Product Code	NJM	NJM	NJM
Material	Alumina (Al2O3)	Alumina (Al2O3)	Alumina (Al2O3)
Clarity	Translucent	Translucent	Translucent
Bracket Design	1-Piece Base andBracket Construction	1-Piece Base andBracket Constructionand a slide	1-Piece Base andBracket Construction
Ligation	Non Self-Ligating	Self-Ligating	Non Self-Ligating
ManufacturingMethod	CIM	CIM	CIM
Hooks	CIM Hooks	CIM Hooks	CIM Hooks
In/Out	.020"-.045"	.035" - .059"	.020" - .045"
Torque	+17° thru -17°	+2° thru -11°	+17° thru -17°
Angulation	Up to +8°	Up to +9°	Up to +8°
Rotation	Up to 2°	0°	Up to 2°
BracketIdentificationand Placement	Temporary color codedplacement indicatorsystem to aid in bracketpositioningTemporary colored dot	Color coded plastic jigto aid in visualplacement	Color coded plastic axisindicator or temporarycolor coded labial tiewings to aid in visualplacement
	to indicateUpper/Lower, Left/Right	Temporary colored dotto indicateUpper/Lower, Left/Right	Temporary colored dotto indicateUpper/Lower, Left/Right
Element	Clarity™ ADVANCED(K102803)	Damon Clear /Damon Clear2(K081415)	Symetri™ Clear(K172845)
MaterialComposition forBracketIdentificationand Placement	Unknown	Bracket Identification –Blue:-PolypropyleneCopolymer- Copper, [29H, 31H-Phthalocyaninato(2-)-N29, N30, N31- Titanium DioxideBracket Identification –Red:-PolypropyleneCopolymer-Iron Oxide-Zinc StearateBracket Identification –Temporary AcrylicPaint-Polyethylene GlycolOctylphenyl EtherPer an independentaccredited medicalresearch service company,the finished device isconsidered to have metbiological evaluation andrisk assessmentrequirements (ISO 10993and ISO 14971).	Bracket Identification –Blue:-PolypropyleneCopolymer- Copper, [29H, 31H-Phthalocyaninato(2-)-N29, N30, N31- Titanium DioxideBracket Identification –Red:-PolypropyleneCopolymer-Iron Oxide-Zinc StearateBracket Identification –Temporary AcrylicPaint-Polyethylene GlycolOctylphenyl EtherPer an independentaccredited medicalresearch service company,the finished device isconsidered to have metbiological evaluation andrisk assessmentrequirements (ISO 10993and ISO 14971).
Bracket Base	Micro-crystalline,mechanical bonding,surface for optimal bondstrength	Laser etch patternstrategically cut onto thebottom of the bracket foroptimal bond strengthbetween the bracket andtooth	Laser etch patternstrategically cut onto thebottom of the bracket foroptimal bond strengthbetween the bracket andtooth
Single Use	Yes	Yes	Yes
Non-SterilePackaging	Yes	Yes	Yes
Debonding HandInstrumentAccessory	Unitek Self-LigatingBracket Debonding	Damon Clear / DamonClear 2 Debonding	Symetri ClearMcLaughlin, Bennett &Trevisi – Debonding
Element	Clarity TM ADVANCED(K102803)	Damon Clear /Damon Clear2(K081415)	Symetri TM Clear(K172845)
*Included forinformationalpurposes only, notfor review forclearance	Instrument(REF: 804-170)	Instrument(REF: 866-4019)	Instrument / Pliers(REF: 866-4025)

12. Predicate, Predicate Reference and Proposed Device Comparison

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13. Clinical Performance Data

Clinical performance testing has not been performed for Symetri Clear.

Conclusion as to Substantial Equivalence 14.

Based upon similarities in the indications for use and technology, biocompatibility testing and performance testing, Symetri Clear brackets have been shown to be substantially equivalent to Clarity ADVANCED brackets (K102803) and to Damon Clear/Damon Clear2 brackets (K081415).

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.