The Smylio Invisible Clear Aligners is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

Device Description

The Smylio Invisible Clear Aligners are intraoral thermoformed plastic aligners that are worn 20 to 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning.

Smylio Invisible Clear Aligners are fabricated using a three-step process.

The first step is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.

The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, the doctor utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. A 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed.

The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission.

AI/ML Overview

Here's an analysis of the provided text regarding the Smylio Invisible Clear Aligners' acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Measure	Acceptance Criteria	Reported Device Performance
Dimensional Accuracy	All translational measurements within 0.3 mm of the target input value.	All translational measurements were within 0.3 mm of the target input value.
	All rotational measurements within 3° of the target input value.	All rotational measurements were within 3° of the target input value.
Biocompatibility	Compliant with ISO 7405:2008 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry).	Tested and shown to be compliant with ISO 7405:2008.

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

The provided text describes a "manufacturing validation" study. While it states that "three critical aspects of the manufacturing process were assessed," it does not explicitly state the sample size (e.g., number of aligners, number of 3D models tested).

The data provenance is not specified regarding country of origin, nor whether it was retrospective or prospective. Given it's a manufacturing validation, it's inherently prospective in the sense of testing newly manufactured prototypes.

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

The document does not mention the use of experts to establish ground truth for the manufacturing validation. The ground truth was established by "target input values" or "predefined tolerance of the manufacturing process." An "independent 3rd party software and digital calipers" were used for measurements.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as experts were not used to establish ground truth. Measurements were taken using instrumentation and compared against predefined tolerances.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing was not conducted."

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

The manufacturing validation study appears to be a standalone performance assessment of the manufacturing process and resulting product (aligners). While software (3Shape®) is involved in the design and planning, the validation focuses on the physical accuracy of the manufactured components (digital models, 3D printed molds, thermoformed aligners) against their intended values, not on the performance of the software as a standalone diagnostic or treatment planning tool in comparison to a human. The independent 3rd party software and digital calipers act as the measurement tools, not as the AI algorithm itself being evaluated.

7. The Type of Ground Truth Used

The ground truth used for the manufacturing validation was based on pre-defined target input values for translational and rotational measurements. These targets represent the intended or desired dimensions and angles planned during the treatment design.

8. The Sample Size for the Training Set

No training set is mentioned or applicable here. The study described is a manufacturing validation, not an AI algorithm development study that would involve training data.

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

Not applicable, as there was no training set.

Summary

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August 23, 2018

Smylio, Inc % Mr. Bill Jacqmein Regulatory Affairs Consultant JCQ Consulting 11218 Zest Court NE Blaine, Minnesota 55449

Re: K173784

Trade/Device Name: Smylio Invisible Clear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: June 7, 2018 Received: June 12, 2018

Dear Bill Jacqmein:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

For Tina 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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510(k) SUMMARY K173784

Submitter:		48890 Milmont DriveFremont, CA 94538
Company ContactPerson:		Renjith S Menon, CEO
	Phone:Email:	(510) 868-2184rmemon@smylio.com
SubmissionCorrespondent:		Bill Jacqmein, Regulatory Affairs Consultant
Address:	Phone:Email:	11218 Zest Ct. NE, Blaine, MN 55449(404) 216-6190bjacqmein@rcqsolutions.com
Date Prepared:		June 6th, 2018
Proprietary Name:		Smylio Invisible Clear Aligners
Common Name:		Orthodontic Plastic Brackets
Product Code:		NXC - Orthodontic Plastic Brackets
Device Classification:		Class II, 21 CFR 872.5470
Primary PredicateDevice:		Derby Dental Laboratory Custom Clear Aligner System(K173785)
Reference Predicates:		3Shape OrthoSystem™ Software (K152086)ClearCorrect System (K113618)

Device Description:

Smylio Invisible Clear Aligners are fabricated using a three-step process.

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Software Description

Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation in this submission is the 3Shape®.

Material:

The material used for the manufacturing validation in this submission is the Zendura®.

Indications for Use:

The Smylio Invisible Clear Aligners is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

Comparison to Predicate Devices:

Table 1: Functional Specification Comparison
FunctionalSpecification	Smylio Invisible ClearAligners	Custom Clear AlignerSystem (K173785)
Material	Co-polyester or Co-Polymer	Co-polyester or Co-Polymer
Mode of Action	Continuous gentle forceapplied to teeth to achievemovement	Continuous gentle forceapplied to teeth to achievemovement
Features:
Device Description	Sequential thermoformedplastic aligners	Sequential thermoformedplastic aligners
PatientRemovable?	Yes	Yes
Duration of Use	20 to 22 hours per day	20 to 22 hours per day
Indication for Use	The Smylio Invisible ClearAligners is indicated for use inthe alignment of permanentteeth through orthodontictreatment of misalignmentand malocclusion.	The Custom Clear Aligneris indicated for use in thealignment of permanentteeth through orthodontictreatment of misalignmentand malocclusion.

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Comparison of Indications for Use to Predicate Devices:

Based on the above comparison, the indications for use of the Smylio Invisible Clear Aligners is similar to that of the Derby Dental Custom Clear Aligner (K173785).

Comparison of Technological Characteristics to Predicate Devices:

Based on the above comparison, the design and construction of the Smylio Invisible Clear Aligners is similar to that of the Derby Dental Custom Clear Aligner (K173785).

Non-clinical performance testing:

Manufacturing Validation

A manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for Smylio Aligners. Three critical aspects of the manufacturing process were assessed for accuracy: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners.

An independent 3rd party software and digital calipers were used to perform point-to-point and critical displacement measurements.

All translational measurements were within 0.3 mm of the target input value and all rotational measurements were within 3° of the target input value, the predefined tolerance of the manufacturing process. There were no statistical differences in the intended and measured values observed from any of the groups. This test has met the pre-established acceptance criteria to demonstrate dimensional accuracy.

Biocompatibility

A biocompatibility assessment was conducted. The Smylio Invisible Clear Aligners have been tested and shown to be compliant with the following standards:

· ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry

Clinical performance testing:

Clinical performance testing was not conducted.

Conclusion:

Based on comparison of indications for use, technological characteristics, performance testing, biocompatibility assessment, we believe that Smylio Invisible Clear Aligners are substantially equivalent to the predicate devices.

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Indications for Use

510(k) Number (if known) K173784

Device Name Smylio Invisible Clear Aligners

Indications for Use (Describe)

The Smylio Invisible Clear Aligners is indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.

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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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.