The proposed device is a 3D-printed bracket system that directly bonds to either primary teeth, permanent teeth, or mixed dentition to provide for orthodontic treatment for patients with malocclusions. Each bracket is 3D printed using a photopolymer denture resin. The Braces on Demand Bracket System has an integral hook design, which allows for attachment of accessories such as elastics or springs to assist the clinician in producing the desired tooth movement. The hook position on the Braces on Demand brackets can be on the mesial occlusal tiewing or the distal occlusal tiewing, similar to traditional orthodontic brackets. The application and removal of the Braces on Demand brackets are similar to other orthodontic brackets in that it requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for de-bonding. The bonding surface of the bracket is a mechanical dovetail undercut design, allowing the bracket to mechanically retain the adhesive and bond to the facial surface of the tooth.

AI/ML Overview

The provided document is a 510(k) Summary for the "Braces on Demand Bracket." It primarily focuses on demonstrating substantial equivalence to predicate devices based on various characteristics, manufacturing processes, and material properties. However, it does not contain information about acceptance criteria for device performance (such as accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/ML devices), nor does it describe a study specifically designed to prove the device meets such criteria.

The information provided relates to testing for physical properties and biocompatibility, which are different from the performance metrics typically found in studies for AI/ML-driven devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them from the given text.

Here's an breakdown of the requested information, indicating why it cannot be extracted:

A table of acceptance criteria and the reported device performance
- Not found. The document discusses "Bond Strength and Hook Strength testing" and "Dimensional Analysis and Dimensional Stability Tests," stating that the device was found "substantially equivalent" to the predicate. However, it does not provide specific acceptance criteria values (e.g., "bond strength > X MPa") or specific reported performance values. It also doesn't mention any performance metrics related to orthodontic movement efficacy that would typically be assessed in a clinical study.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not found. No information is given about sample sizes for any performance testing, nor about data provenance.
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 found. This section is relevant for studies involving human experts for ground truth assessment (e.g., image interpretation). This document does not describe such a study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not found. This is typically associated with ground truth establishment by multiple experts. Not applicable here.
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
- Not found. The document explicitly states: "No animal or human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by method similar to the predicate device." Therefore, no MRMC study or study involving human readers with/without AI assistance was conducted or reported.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not found. While the device involves software for design and manufacturing, the document does not describe a standalone performance study of an algorithm in the context of clinical decision-making or diagnosis. The software verification and validation are for the manufacturing process, not for clinical performance metrics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not found. Since performance studies with clinical outcomes are not described, there is no mention of ground truth types.
The sample size for the training set
- Not found. The document does not describe a machine learning model that would require a training set.
How the ground truth for the training set was established
- Not found. Not applicable.

In summary, the provided 510(k) Summary focuses on demonstrating substantial equivalence based on technical specifications, materials, manufacturing processes, and static physical property tests, rather than detailing clinical performance studies with specific acceptance criteria and outcome metrics that would be typical for an AI/ML powered device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

December 3, 2020

Braces on Demand, Inc % Patsy Trisler Regulatory Consultant Oserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K201940

Trade/Device Name: Braces on Demand Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: DYW, PNN Dated: October 23, 2020 Received: October 28, 2020

Dear Patsy Trisler:

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.

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

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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 (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,

Michael Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental 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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Indications for Use

510(k) Number (if known)

K201940

Device Name

Braces on Demand Bracket

Indications for Use (Describe)

The Braces on Demand Bracket is intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.

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

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K201940 510(k) Summary

Submitter Name:	Braces on Demand, Inc.
Submitter Address:	422 South Broadway, Suite 203Hicksville, NY 11801
Email Address:	colin.corey@bracesondemand.com
Telephone:	(516) 477-8377
Contact Person:	Colin CoreyCEO
Date Prepared:	July 8, 2020
Device Trade Name:	Braces on Demand Bracket
Common Name	Orthodontic Plastic Bracket, Orthodontic Software
	Predicate A	Predicate B
Predicate DevicesClassification Name	Orthodontic Plastic Bracket	Orthodontic Software
Number	21 CFR 872.5470	21 CFR 872.5470
Product Code	DYW	PNN
Regulatory Class	2	2
Predicate Name	K140807, Composite Brackets,Ortho Specialties, Inc.	K180941, 3Shape OrthoSystem™; 3Shape A/S
Reference Device	K172398, Dentca Denture Teeth, Denterprise International, Inc.
Indications for UseStatement:	The Braces on Demand Bracket System is intended for use asa clear, plastic bracket system to provide orthodontic movement ofnatural teeth.
Device Descriptionand Summary ofTechnologicalCharacteristics	The proposed device is a 3D-printed bracket system that directlybonds to either primary teeth, permanent teeth, or mixed dentitionto provide for orthodontic treatment for patients withmalocclusions. Each bracket is 3D printed using a photopolymerdenture resin.
	The Braces on Demand Bracket System has an integral hookdesign, which allows for attachment of accessories such aselastics or springs to assist the clinician in producing the desiredtooth movement. The hook position on the Braces on Demandbrackets can be on the mesial occlusal tiewing or the distalocclusal tiewing, similar to traditional orthodontic brackets.
	The application and removal of the Braces on Demand bracketsare similar to other orthodontic brackets in that it requiresorthodontic adhesive for bonding and standard orthodontic toolsand techniques for de-bonding. The bonding surface of thebracket is a mechanical dovetail undercut design, allowing thebracket to mechanically retain the adhesive and bond to the facialsurface of the tooth.

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Image /page/4/Figure/2 description: The image is a flowchart outlining the manufacturing process for "The Braces on Demand". The process begins with logging into the software and selecting a device to print, followed by selecting the resin. The flowchart then splits into two paths: "Select Print In-House" and "Order For Deliver", eventually converging at "Add device to cart" and then splitting again into "Buy and Print" and "All manufacturing to be done at the manufacturing facility".

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	Brand	Model	Type
PrintingSystems:	Formlabs	Form 3	SLA
	Formlabs	Form 2	SLA
SoftwareSystems:	Formlabs	PreForm	Printer software
	Formlabs	Dashboard	Print monitoring software
PostProcessingSystems:	Formlabs	Form Wash	Agitation cleaning system
	Formlabs	Form Cure	UV post curing system

Equipment and software validated for printing and postprinting processing:

Based on a clinician's treatment plan, each bracket is used as Mechanism of Action prescribed to exert the force required for movement of the teeth.

Device Testing Laboratory Testing

Bond Strength and Hook Strength testing were performed on the Braces on Demand Bracket System and compared to the predicate device was found to be substantially equivalent.

Dimensional Analysis and Dimensional Stability Tests were performed on the Braces on Demand Bracket System to validate the manufacturing process and prove the design inputs match the manufacturing outputs.

Software verification and validation testing was performed according to FDA's published guidance documents and supporting documents submitted in this 510(k) based on the software being of "Minor Level of Concern".

Biocompatibility

The following ISO 10993 testing was performed according to Good Laboratory Practices to assess the safety and biocompatibility of the plastic material:

Part 5 (Cytotoxicity Elution - MEM),

The reference device, utilizing the same exact materials and processes, also underwent the following testing:

Part 10 (Intracutaneous/Intradermal) Reactivity),

Part 10 (Maximization for Delayed-Type Hypersensitivity),

Part 11 (Subacute Systemic Toxicity)

This testing has shown that the material is safe and biocompatible for the stated intended use.

Animal | Human Testing

No animal or human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by method similar to the predicate device.

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Comparison to The Braces on Demand Bracket System, compared to the two Predicate Devices: predicate devices:

. The intended use is the same.
. The mechanisms of action (software and bracket systems) are similar.
I The material used to make the brackets is similar to the predicate and is produced in the same manner (by additive manufacturinq) as the reference device.
I The software used during the manufacturing processes is similar.

Based on the documentation presented in the 510(k), as Substantial Equivalence summarized above, it can be concluded that this software system Conclusion and the produced brackets are substantially equivalent to the predicate devices.

Element	Braces on Demand(Proposed Device)	Ortho Specialties(Predicate Device)	Comparison
Company	Braces on Demand Inc.	Ortho Specialties Inc.	N/A
510(k)	To be Assigned	K140807	N/A
Indications for Use	The Braces on DemandBrackets are intendedfor use as a clear,plastic bracket systemto provide orthodonticmovement of naturalteeth.	The Composite Bracketsare intended for use as aclear, plastic bracketsystem to provideorthodontic movement ofnatural teeth.	Indicated for the samepurpose – movementof teeth.
Target Users	Dental Professionalstrained in orthodontics.	Dental Professionalstrained in orthodontics.	Same
ApplianceMaterial	Biocompatible plastic,photopolymer	Biocompatible plastic,polycarbonate	Same category ofbiocompatible plastic.Difference inmanufacturing method– Braces on Demandphotopolymer is meantfor 3D Printing and theOrtho Specialtiespolycarbonate ismeant for injectionmolding.
Features	Clear (translucent toothtone) bracket system	Clear (translucent)bracket system	Both brackets systemsoffer an aesthetictreatment option, theBraces on Demandsystem is more toothtone with sometransparency, theOrtho Specialties ismore transparent withsome minor whitecoloring

Table A Substantial Equivalence Summary - Predicate A

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Mode of use	Archwireimplementation bydental professional'stechnique	Archwire implementationby dental professional'stechnique	Same
PhysicalProperties	Mechanical Retentionbase eliminated need forplastic condition pre-treatment. Toothposition printed onbracket foridentification.	Mechanical Retentionbase eliminated need forplastic condition pre-treatment. Non-toxic inkon brackets foridentification.	Same mechanicalretention base. Toothposition identificationis directly printed intothe part with Braceson Demand brackets,eliminating the needfor ink dots.
Application	Bonded	Bonded	Same
ManufacturingMethod	3D Printed	Molded, thermoformed	Braces on Demandbrackets utilize anadditive manufacturingprocess (3D Printing)to create the finished,isotropic shape layerby layer. The OrthoSpecialties Bracketutilized plastic injectionmolding to transformthe molten plastic intothe final desiredshape.

Table B Substantial Equivalence Summary – Predicate B

Element	Braces on DemandBracket(Proposed Device)	3ShapeOrtho System(Predicate Device)	Comparison
Company	Braces on DemandInc.	3Shape Inc.	N/A
510(k)	To be Assigned	K180941	N/A
Indications forUse	The Braces onDemand Brackets areintended for use as aclear, plastic bracketsystem to provideorthodonticmovement of naturalteeth.	Ortho System™ fordental retainers anddental cast for sequentialaligners is intended foruse as a medical front-end device providingtools for management oforthodontic models,systematic inspection,detailed analysis,treatment simulation andvirtual appliance designoptions based on 3Dmodels of the patient'sdentition before the startof an orthodontictreatment.	The 3Shape system isdesigned around usingremovable clearaligners, whereas theBraces on Demandsystem is designedaround using directbonded appliances(brackets). Bothsystems utilize tools tomanage appliances,and fabricate saidappliances using 3Dprinters with STL fileformats.
Target Users	Dental Professionalstrained inorthodontics.	Dental Professionalstrained in orthodontics.	Same

ApplianceMaterial	Medical gradeplastic,photopolymer	Medical grade plastic,thermoformed (K062828)	Same category ofmedical plastic.Difference inmanufacturing method– Braces on Demandphotopolymer is meantfor 3D Printing and the3Shape alignermaterial is meant forthermoforming after a3D printed model iscreated.
Features	Clear (translucenttooth tone) bracketsystem	Clear (translucent)removable retainer	Both systems offer anaesthetic treatmentoption, the Braces onDemand system isdirect bonded to thetooth while the 3Shapesystem is removable.
Mode of use	ComputerApplication, forclinician to specifyand design themedical device formanufacturing	Computer Application,for the clinician to specifyand design the series ofmedical devices formanufacturing	Similar applications,the difference is in thenature of direct bondedappliances of Braceson Demand vs. theremovable clearaligners of 3Shape
PhysicalProperties	Direct bondedappliance.	Removable appliancedoes not require anybonding.	Different method ofaction, the directbonded appliance ofBraces on Demand vs.the removable clearaligner of 3Shape.
Virtual planningof orthodontictreatmentssimulating toothmovements	No	Yes	No simulated toothmovement isnecessary fortraditional directbonded appliances.
Stereolithography(STL file format)	Yes	Yes	Same
ManufacturingMethod	3D Printed	3d Printed, thenthermoformed	Braces on Demandbrackets utilize anadditive manufacturingprocess (3D Printing)to create the finished,isotropic shape layerby layer.The 3ShapeOrtho System utilizes3D printing of models,and subsequentthermoforming tocreate the sequentialclear aligners.

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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.