The SmileSeries™ is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in adult and adolescent patients with permanent dentition (i.e. all second molars). The SmileSeries™ positions teeth by way of continuous gentle force.

Device Description

The SmileSeries™ is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. SmileSeries™ aligners are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) takes provides physical or scanned impressions of the patient's teeth to SmileSeries™. A digital setup of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the device "SmileSeries™" by Ordont Orthodontic Laboratories, Inc. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, not to prove that the device meets specific acceptance criteria through a clinical study in the way one might for a novel diagnostic AI algorithm.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of performance metrics that would be applicable to an AI device (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) is not present in this document.

Instead, this document describes a comparison to a predicate device based on intended use, technological characteristics, materials, and manufacturing processes, supported by bench testing for manufacturing accuracy and biocompatibility testing of the plastic material.

Here's how to address your points based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not present quantitative performance acceptance criteria or reported performance results in the typical sense for a diagnostic device. Since SmileSeries™ is an orthodontic appliance (a physical device), the "acceptance criteria" revolve around demonstrating that it is substantially equivalent to a predicate device, meaning it is as safe and effective as a legally marketed device.

The "performance" is primarily shown through:

Identical Indications for Use: The SmileSeries™ is used for the same purpose as the predicate.
Similar Technological Characteristics: Same material (thermoformed plastic), similar manufacturing process (forming plastic sheets on models), and the same software used for planning.
Successful Bench Testing: To validate the manufacturing process and ensure accuracy of the final aligner compared to the digital scan. No specific numerical results or benchmarks from this bench testing are provided in this summary, only that a "final report was part of the 510(k) package."
Biocompatibility: The material meets requirements, referencing prior 510(k) submissions.

Table based on the document's comparison of characteristics:

Feature/Characteristic	SmileSeries™ (Proposed Device)	ClearPath Aligner (Predicate Device)	Comparison
Regulation Number	21 CFR 872.5470	21 CFR 872.5470	Same
Regulation Name	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket	Same
Product Code	NXC	NXC	Same
Regulatory Class	Class II	Class II	Same
Indications for Use	Correction of dental malocclusion in adult and adolescent patients with permanent dentition by continuous gentle force.	Correction of dental malocclusion in patients with permanent dentition by continuous gentle force.	Same
Mode of Action	Removable appliance applies gentle forces on teeth according to doctor's plan.	Removable appliance applies gentle forces on teeth according to doctor's plan.	Same
Description of Use	Each removable preformed plastic tray worn for a few weeks before next sequential tray.	Each removable preformed plastic tray worn for a few weeks before next sequential tray.	Same
Material	Thermoformed plastic	Thermoformed plastic	Same
Manufacturing Process	Forming of plastic sheets on unique dental models using thermoforming machine.	Forming of plastic sheets on unique dental models using thermoforming machine.	Same
Software Used	Yes, for treatment planning and 3D printing of models (Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S).	Yes, for treatment planning and 3D printing of models (Same software).	Same
Prescription Use	Rx	Rx	Same
Biocompatibility	Yes, shown to meet requirements	Yes, shown to meet requirements	Same
Validation Testing	Yes, performed (bench testing)	Yes, performed	Same

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes bench testing for manufacturing accuracy, not clinical performance testing with a "test set" of patients or data, as would be common for an AI device. Therefore, a "sample size" in that context is not applicable or provided. The document states:

"Bench testing was performed to validate the manufacturing process, to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan."
"A final report was part of the 510(k) package."

No details on the sample size of items tested, data provenance, or retrospective/prospective nature are provided for this bench testing in this summary.

3. 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 device is an orthodontic appliance, not a diagnostic AI system requiring expert-derived ground truth for a test set. The validation focuses on manufacturing accuracy and material safety, not diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As above, this is not a diagnostic study requiring adjudication of expert readings.

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

Not applicable. This is not an AI-assisted diagnostic device. The study performed was bench testing of the physical aligner and its manufacturing process, and biocompatibility testing of the material. The document explicitly states: "In vivo Animal and Human Clinical performance testing are not required for this device category."

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

Not applicable. This is not an algorithm-only device. The reference to software (Ortho Analyzer) is for treatment planning and 3D printing of models for the creation of the aligners, not for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench testing, the "ground truth" would implicitly be the initial digital scan or design specifications of the aligner, against which the accuracy of the final thermoformed aligner was compared. It's a comparison to a precise digital model, not a biological or clinical ground truth in the sense of disease presence.

8. The sample size for the training set

Not applicable. This refers to an AI training set, which is not relevant to this physical device submission.

9. How the ground truth for the training set was established

Not applicable. As per point 8.

Summary

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July 14, 2022

Ordont Orthodontic Laboratories, Inc. % Patsy Trisler Regulatory Consultant Trisler Consulting, dba 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K221097

Trade/Device Name: SmileSeries Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: April 13, 2022 Received: April 14, 2022

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 E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K221097

Device Name

SmileSeries™

Indications for Use (Describe)

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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SECTION 5

510(k) SUMMARY

SUBMITTER
Submitter Name:	Ordont Orthodontic Laboratories, Inc.
Submitter Address:
Contact Person:Email:Telephone:	Paul Ruzicka, CDAPaul@ordont.com800-325-3698
Date Prepared:	April 13, 2022
DEVICE
Device Trade Name:	SmileSeries™
Common Name:	Aligner, Sequential (Clear Braces)
Classification NameNumberProduct CodeRegulatory Class	Orthodontic Plastic Bracket21 CFR 872.5470NXC2
Review Panel	Dental
PREDICATE DEVICE	Primary Predicate:K202857, ClearPath Aligner, ClearPath OrthodonticsReference Device:K180941 Ortho System™, 3Shape A/S
DEVICEDESCRIPTION	The SmileSeries™ is comprised of a series of clear, thin,thermoformed removable aligner trays that are designed tocorrect tooth malocclusions without the use of conventionalwire and bracket orthodontic technology. SmileSeries™aligners are provided non-sterile and are customized for eachpatient according to the dental clinician's prescription.The dental health professional (dentist/orthodontist) takesprovides physical or scanned impressions of the patient's teethto SmileSeries™. A digital setup of either the scannedimpression or a scan of the physical impression is sent to theclinician for approval. Upon approval, molds are then createdwith 3D-printing technology and the clear aligners arethermoformed on the molds and laser marked.The finished, customized aligners are provided to the dentalhealth care professional who provides them to the patient,confirming fit and design. The aligner trays are held in place bypressure and can be removed by the patients at any time.
MECHANISM OFACTION	Each aligner in the set is used for the specified period of time,usually 2-3 weeks, to exert gentle force to achieve progressiverealignment of the teeth until the final correction has beenachieved. The daily treatment time is usually 22 hours, orexcept during eating, based on the clinician's prescribedtreatment plan.
SUMMARY OFTECHNOLOGICALCHARACTERISTICS	The thermoplastic material used for the manufacture of theSmileSeries™ aligner is the same material used to make thepredicate ClearPath Aligner.
	The software system used is Ortho Analyzer, 2019 ver 1.8.1.0by 3Shape A/S (Reference device - K180941). It also is thesame as used for the Predicate. It is used for management of3D scanned orthodontic models, orthodontic diagnosis bymeasuring, analyzing, inspecting and visualizing 3D scannedorthodontic models, virtual planning of orthodontic treatmentsby simulating tooth movements, and design of orthodonticappliances based on 3D scanned orthodontic models.
INDICATIONS FORUSE STATEMENT	The SmileSeries™ is a series of clear, lightweight, plasticappliances indicated for the correction of dental malocclusion inadult and adolescent patients with permanent dentition (i.e. allsecond molars). The SmileSeries™ positions teeth by way ofcontinuous gentle force.
SAFETY TESTING	Biocompatibility: Testing of the plastic thermoformable materialused to make the SmileSeries™ aligners has been provided inprevious 510(k) submissions to FDA.
PERFORMANCETESTING	Bench testing was performed to validate the manufacturingprocess, to ensure the accuracy of the final thermoformedaligner compared to the initial digital scan. A final report waspart of the 510(k) package.
	In vivo Animal and Human Clinical performance testing are notrequired for this device category.
COMPARISON TOTHE PREDICATEDEVICE	The SmileSeries™ aligner has the same intended use as thepredicate device. The thermoplastic material is the same andthe design phase makes the use of the same software as thepredicate. The manufacturing fabrication of the clear alignermakes use of similar, industry-standard processes with thesame or similar machines and materials. Any differences in thespecific company processes do not raise new questions ofsafety and effectiveness.
SUBSTANTIALEQUIVALENCECONCLUSION	The information and data provided in this 510(k) establish thatthe SmileSeries™ is substantially equivalent to the predicateClearPath Aligner in the intended use, design, principle ofoperation, technology, and thermoformable material used tomake the aligner. Comparison of all key parameters arepresented in the following SE Comparison table

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510(k) Number	Proposed DeviceK	Predicate DeviceK202857	Comparison
Device Name	SmileSeries™	ClearPath Aligner	N/A
Manufacturer	Ordont OrthodonticLaboratories, Inc.	ClearPath Orthodontics, Ltd	N/A
ClassificationRegulationNameProduct CodeClass	21 CFR 872.5470Orthodontic Plastic BracketNXC2	21 CFR 872.5470Orthodontic Plastic BracketNXC2	Same
Indications forUse	The SmileSeries™ is aseries of clear, lightweight,plastic appliances indicatedfor the correction of dentalmalocclusion in adult andadolescent patients withpermanent dentition (i.e. allsecond molars). TheSmileSeries™ positions teethby way of continuous gentleforce.	The ClearPath Aligner is aseries of clear, lightweight,plastic appliances indicatedfor the correction of dentalmalocclusion in patients withpermanent dentition (i.e. allsecond molars). TheClearPath Aligner positionsteeth by way of continuousgentle force.	Same
Mode of Action	The removable applianceapplies gentle forces on teethaccording to the planprescribed by the doctor.	The removable applianceapplies gentle forces on teethaccording to the planprescribed by the doctor	Same
Description ofUse	Each removable preformedplastic tray, prescribed by theDr, is worn by the patientusually for a few weeks, priorto using the next sequentialaligner tray.	Each removable preformedplastic tray, prescribed by theDr, is worn by the patientusually for a few weeks, priorto using the next sequentialaligner tray.	Same
Material	Thermoformed plastic	Thermoformed plastic	Same
ManufacturingProcess	Forming of plastic sheets onunique dental models usingthermoforming machine	Forming of plastic sheets onunique dental models usingthermoforming machine	Same
Software Used	Yes, for treatment planningand 3D printing of models.	Yes, for treatment planningand 3D printing of models.	Same
PrescriptionUse	Rx	Rx	Same
Biocompatibility	Yes, shown to meetrequirements	Yes, shown to meetrequirements	Same
ValidationTesting	Yes, performed	Yes, performed.	Same

Substantial Equivalence Comparison Table

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.