The iSMILE is a sequence of transparent aligners created from a digital orthodontic treatment plan. The iSMILE aligner is fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivery a unique combination of minor forces to create the planned tooth movement. The digital orthodontic treatment plan is created by a dental health professional. The iSMILE Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the iSMILE Dental Aligners, comparing it to a predicate device, the Invisalign System. The document focuses on demonstrating substantial equivalence rather than providing a detailed study report for novel performance claims.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text indicates that the device underwent non-clinical performance tests to demonstrate substantial equivalence. These tests focused on material properties and process validation. Rather than specific quantitative acceptance criteria for each test, the document states generally that the device met "acceptable results" or "acceptance criteria."

Test Category	Specific Test / Property	Acceptance Criteria	Reported Device Performance
Material Properties (Biocompatibility)	Cytotoxicity	Passed Biocompatibility testing per ISO 10993-1	Passed
	Sensitization	Passed Biocompatibility testing per ISO 10993-1	Passed
	Irritation	Passed Biocompatibility testing per ISO 10993-1	Passed
	Acute Systemic Toxicity	Passed Biocompatibility testing per ISO 10993-1	Passed
	Mutagenicity	Passed Biocompatibility testing per ISO 10993-1	Passed
	Subacute Toxicity	Passed Biocompatibility testing per ISO 10993-1	Passed
Material Properties (Mechanical)	Tensile Strength Yield	Acceptable results in comparison to samples tested (no defined specification or standard)	Produced acceptable results
	Aligner Elongation (Break Point)	Acceptable results in comparison of break point (no defined specification or standard)	Showing acceptable results
	Tensile Stress at Break Point	Acceptable results (no defined specification or standard)	Produced acceptable results
	Modulus	Acceptable results between the samples tested (no defined specification or standard)	Showed acceptable results between the samples tested
	Load of Materials	Acceptable results (no defined specification or standard)	Found acceptable results
	Water Absorption	Acceptable results (no defined specification or standard)	Found acceptable results
Process Validation	Process Flow Validation (Finished device matches software output specifications)	Not explicitly stated, but implies the finished device must match the software output specifications, meaning the aligners themselves must accurately reflect the digitally planned tooth movement and morphology. The text states: "The output and work model and aligner were tested and compared. Aligners met the acceptance criteria of this testing." This indicates the acceptance criteria was likely a measure of geometric accuracy or fit.	Aligners met the acceptance criteria. The iSMILE functioned as intended and observed as expected. The results of this performance testing are accepted according to acceptance criteria and do not raise any additional concerns.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for the test set used for these non-clinical performance tests. For material tests (tensile strength, elongation, stress, modulus, load, water absorption), it refers to "a sample of base materials" or "samples tested." For biocompatibility, it states "the used thermoforming sheets," implying the specific material intended for the device. For Process Flow Validation, it mentions "the output and work model and aligner were tested and compared," but no numbers are provided.

The data provenance is internal, as 3D Diagnostix Inc. completed the tests to support their 510(k) submission. There is no information regarding country of origin for test data or whether it was retrospective or prospective, as these are non-clinical engineering and material tests, not clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to the provided document. The tests performed are non-clinical, focusing on material and manufacturing process validation. There is no mention of a "ground truth" derived from expert consensus for clinical accuracy in the context of expert review.

4. Adjudication Method for the Test Set

This section is not applicable. The tests described are laboratory-based engineering and material performance tests, not clinical evaluations requiring adjudication of expert interpretations.

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

This section is not applicable. The device described is a physical dental aligner, not an AI diagnostic or assistive software. No MRMC study was conducted or mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a physical product (dental aligners), not an algorithm or AI software. There's mention of "software output specifications" in relation to Process Flow Validation, meaning software designs the aligners, but the performance testing is for the physical aligner's manufacturing and material properties, not the diagnostic accuracy of the software itself.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical tests, the "ground truth" is based on established scientific and engineering principles, national/international standards (like ISO 10993-1 for biocompatibility), and internal specifications. For mechanical properties, where no external standards existed, internal comparisons of "acceptable results" were used. For Process Flow Validation, the "ground truth" was likely the digital design specifications derived from the software output. No pathology or outcomes data is mentioned as ground truth for these non-clinical tests.

8. The Sample Size for the Training Set

This section is not applicable. The document describes a physical medical device and its non-clinical performance tests for 510(k) clearance, not an AI algorithm that would require a training set.

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

This section is not applicable for the same reasons as #8.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

December 22, 2020

3D Diagnostix Inc. Ehab Amin Ouality and Regulatory Consultant 24 Denby Road Allston, Massachusetts 02134

Re: K200908

Trade/Device Name: iSMILE Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 27, 2020 Received: November 27, 2020

Dear Ehab Amin:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 mediation-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 E. 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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iSMILE Dental Aligners 510K Traditional File

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

Form Approved: OMB 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known) K200908

Device Name

iSMILE

Indications for Use (Describe)

iSMILE is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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iSMILE Dental Aligners 510K Additional Information

510(k) SUMMARY

3D Diagnostix Inc.'s iSMILE

510K Number: K200908

Submitter's Name, Address, Telephone Number, Contact Person

and Date Prepared

[COMPANY'S NAME AND ADDRESS]

3D Diagnostix Inc

24 Denby Road

Allston, MA 02134

USA

Phone: 1-617-820-5279

Fax: 1-617-904-1853

Contact Person: Ehab Mahmoud

Date Prepared: November 23, 2020

Name of Device and Name/Address of Sponsor

Name of Device:	iSMILE
Common or Usual Name:	Dental Plastic Aligners
Classification Name:	Orthodontic Plastic Brackets – Sequential Aligners (21 CFR 892.5470)
Regulatory Class:	II
Product Code:	NXC

Primary Predicate Devices

Invisalign System

K081960

Align Technology, Inc.

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Image /page/4/Picture/0 description: The image shows the logo for 3D Diagnostix. The logo is split into two parts by a vertical line. On the left side of the line is the text "3D" in a blue sans-serif font. On the right side of the line is the text "Diagnostix" in an orange sans-serif font, with ".COM" in a smaller font below the word "Diagnostix".

iSMILE Dental Aligners 510K Additional Information

Intended Use / Indications for Use

The i5MLE is indicated for use in alignment of teeth during orthodontic treatment of malocclusion.

Technological Characteristics

The iSMILE Aligners that are produced have the same technological characteristics as the primary predicate device, in that all the devices are made from commercially available plastic that is thermoformed to create a customized, patient-specific aligners are then used for minor tooth movement by way of continuous gentle force.

In both devices, the aligners are created by thermoforming commercially available plastic material. The iSMILE Aligners are thermoformed by 3D Diagnostix Inc. and in the case of the primary predicate device; the aligners are thermoformed by an outside laboratory.

The iSMILE Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.

Performance Data

As part of demonstrating substantial equivalence of iSMILE to the primary predicate device that are subject to this 510(k) submission, 3D Diagnostix Inc. completed a number of non-clinical performance tests. iSMILE meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device.

iSMILE passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

Biocompatibility testing per ISO 10993-1 passed cytotoxicity, sensitization, irritation, Acute Systemic Toxicity, Mutagenicity, and Subacute Toxicity for the used thermoforming sheets.
There is no defined specification or standard for tensile strength so a sample of base materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile strength yield.

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iSMILE Dental Aligners 510K Additional Information

There is no defined specification or standard for aligner elongation which a sample of based materials used for fabrication of aligners were tested and analyzed showing acceptable results in comparison of break point.
There is no defined specification or standard for tensile stress so a sample of base materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile stress at break point.
There is no defined specification or standard for modulus so this was tested for the base materials used for fabrication of aligners to show acceptable results between the samples tested.
. There is no defined specification or standard for load of materials which found acceptable results when tested and analyzed for samples of base material tested used for fabrication of aligners.
. There is no defined specification or standard for water absorption which found acceptable results when tested and analyzed for fabricated aligners.
Process Flow validation was performed to ensure that the finished device matches the software output specifications. The output and work model and aligner were tested and compared. Aligners met the acceptance criteria of this testing.

In all instances, the iSMILE functioned as intended and Biocompatibility Testing, and Process Flow Validation observed was as expected.

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Substantial Equivalence

Feature	Proposed DeviceiSMILE	Primary Predicate DeviceInvisalign System
K Number	K200908	K081960
Manufacturer	3D Diganostix Inc.	Align Technology, Inc.
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470
DeviceClassificationName	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket
Product Code	NXC	NXC
Device Class	Class II	Class II
Indications forUse	iSMILE is indicated for the alignment ofteeth during orthodontic treatment ofmalocclusion.	The Invisalign System is indicated forthe alignment of teeth duringorthodontic treatment ofmalocclusion.
Device Description	The iSMILE is a sequence oftransparent aligners created from adigital orthodontic treatment plan.The iSMILE aligner is fabricated of atransparent thermoformedpolyurethane plastic. Each alignerdelivery a unique combination ofminor forces to create the plannedtooth movement.The digital orthodontic treatment planis created by a dental healthprofessional.The iSMILE Aligner incorporates theuse of attachments to create spacesand force points in order to causeminor tooth movement. These forcepoints are located in specific areasand positioned in such a way that	The current Invisalign system is aseries of clear plastic aligners that areused to replace traditional orthodonticwires and brackets for the alignmentof maloccluded or misaligned teeth.This series of aligners moves the teethgently, and in small increments, fromtheir original to their final treatedposition for improved dentalalignment.

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3D Diagnostix· COM	3D Diagnostix Inc.
	iSMILE Dental Aligners 510K Additional Information

Feature	Proposed DeviceiSMILE	Primary Predicate DeviceInvisalign System
K Number	K200908	K081960
	they provide a continuous forcewhich slowly dissipates over time onthe tooth to be moved for as long asthe aligner is worn.
Mode ofAction	Orthodontic toothmovement occurs throughforces applied by theappliance to the dentitionas each tooth follows theprogrammed displacementbased on a doctor'sprescription	Orthodontic toothmovement occurs throughforces applied by theappliance to the dentitionas each tooth follows theprogrammed displacementbased on a doctor'sprescription
Anatomy Location	Mouth; mucosal	Mouth; mucosal
Size	Patient specific	Patient specific
ManufacturingMethod	Thermoforming	Thermoforming
Material	Thermoplastic Polymer	Thermoplastic Polymer
MaterialProperties	Demonstrates sufficienttensile strength, elasticity,ductility, chemical resistance,and clarity for use as a cleartray aligner.	Demonstrates sufficienttensile strength, elasticity,ductility, chemical resistance,and clarity for use as a cleartray aligner.
Software Usedfor OrderingWorkflow	Yes	Yes

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Image: 3D Diagnostix Logo	3D Diagnostix Inc.
	iSMILE Dental Aligners 510K Additional Information

Feature	Proposed DeviceiSMILE	Primary Predicate DeviceInvisalign System
K Number	K200908	K081960
Design	Image: iSMILE aligner	Image: Invisalign aligner

iSMILE has the same intended uses and similar indications, technological characteristics, Manufacturing Method, Material Used and principles of operation as its primary predicate device. iSMILE is substantial equivalent to the Invisalign System.

There are no differences between iSMILE and Invisalign System was defined therefore a performance testing was performed to iSMILE to ensure that patients are receiving the aligners as prescribed by the practitioner to move their teeth as intended (final position). The results of this performance testing are accepted according to acceptance criteria and do not raise any additional concerns.

Conclusions

iSMILE Aligners moves teeth by way of continuous gentle force through a sequence of clear aligners that follow the treatment plan developed by the clinician as does the primary predicate device, Invisalign System.

The conclusions drawn from the data included in this submission, demonstrates that the iSMILE Aligner is substantially equivalent to the primary predicate devices cleared under premarket notification K081960 (Primary Predicate Device) in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.

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.