The Ortho Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Ortho Aligner System positions teeth by way of continuous gentle force.

Device Description

The Ortho Aligner System 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. The aligners are provided non-sterile and are customized for each patient according to the dental practitioner's prescription.

Physical impressions or digital intraoral scans of the patient's teeth are provided to Ortho Lab Services. A treatment plan consisting of 3D models is created from the impressions or scans, by Ortho Lab Services using the OrthoWare software. Upon approval of the treatment plan by the treating dental practitioner using OrthoPortal and issuance of an electronic prescription, the clear aligners are manufactured using thermoforming methods.

The finished, customized aligners are shipped based on the dental practitioner's order and confirmed for patient fit and design.

The aligner trays are held in place by pressure and can be removed by the patient at any time.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the Ortho Aligner System. It asserts substantial equivalence to a predicate device, focusing on material, design, manufacturing process, and safety testing rather than a standalone performance study with specific acceptance criteria related to clinical efficacy metrics (like sensitivity, specificity, or reader improvement with AI).

Therefore, based only on the provided text, a comprehensive answer to your request regarding acceptance criteria and a study proving device performance against those criteria (especially in the context of an AI-driven device with human-in-the-loop performance) cannot be fully provided.

Here's an attempt to answer based on the information available, and highlighting what is not present where your questions are relevant to AI/diagnostic performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" in the way a diagnostic AI device would (e.g., target accuracy, sensitivity, specificity). Instead, it focuses on demonstrating equivalence to the predicate device through various non-clinical tests.

Category	Acceptance Criteria (Implied Equivalence)	Reported Device Performance (Ortho Aligner System)
Biocompatibility	Meet ISO 10993-1, -5 (Cytotoxicity), and -10 (Sensitization/Irritation) requirements for the material and finished device.	Passed: Testing performed for the material supplier and for the finished thermoformed aligner meeting ISO 10993-1, Part 5 (Cytotoxicity), and Part 10 (Sensitization) requirements. All biocompatibility testing passed the test requirements.
Software Verification & Validation (V&V)	Software system confirms acceptance to required specifications (per FDA's guidance document).	Confirmed Acceptance: Software V&V testing, using FDA's guidance document, confirmed acceptance to required specifications.
Bench Testing (Manufacturing Process Validation)	Ensure accuracy of the final thermoformed aligner compared to the initial digital scans; aligners meet specifications of the testing.	Met Specifications: Testing to validate the manufacturing process was performed. The test results ensured the accuracy of the final thermoformed aligner compared to the initial digital scans. Aligners met the specifications of the testing.
Material	Same type of biocompatible material as the predicate (PET-G thermoplastic sheet).	Same Type: Thermoplastic PETG, which is the same material type as the predicate.
Manufacturing Process	Standard methods and equipment to thermoform the designed aligners, similar to the predicate.	Similar Methods: Thermoforming on models, which is the same process method as used by the Predicate device manufacturer, using standard methods and equipment.
Software Functionality	Same purpose as predicate's software: treatment planning and design via digital scans to generate images of final treated states, intermediate steps, and convert files for aligner production.	Same Purposes/Similar Software: Ortho Lab Services uses OrthoWare software, which is similar to the Predicate manufacturer's Smart Moves Complete 3-D software. Both use digital scans to generate images and produce customized aligners.
Indications for Use	Same as the predicate device.	Same: Indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars), positioning teeth by way of continuous gentle force. This is identical to the predicate's indications.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated for performance testing regarding the aligner's ability to correct malocclusion in patients. The "Bench testing" refers to validation of the manufacturing process's accuracy against digital scans, not a patient cohort. Biocompatibility testing results are reported for the material and a finished thermoformed aligner, but specific sample sizes of tested items are not provided.
Data Provenance: Not specified. The document relates to a 510(k) submission, not a clinical trial report where such details would be standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is typically relevant for diagnostic AI devices where expert readings establish ground truth. For the Ortho Aligner System, which is a physical device for orthodontic treatment, "ground truth" relates to material properties, manufacturing accuracy, and the mechanical ability to apply force for tooth movement. The document does not describe expert human readers establishing ground truth. The "treatment plan" is approved by "the treating dental practitioner."

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

Not applicable in the context of this device and the described testing. Adjudication methods are used in diagnostic studies, typically involving multiple readers.

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

No MRMC study was performed or described. This type of study is relevant for AI-assisted diagnostic tools. The Ortho Aligner System itself is an aligner, and its associated software (OrthoWare) is for treatment planning and design, not for diagnostic assistance to human readers in the way an AI medical imaging algorithm would be.

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

A standalone software V&V was conducted, confirming the software (OrthoWare) met its specifications. However, this is for the software that designs the aligners, not a standalone diagnostic algorithm whose performance needs to be measured independently of human input. The entire system (aligners + software) is designed to be used by a dental practitioner (human-in-the-loop) for treatment.

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

The "ground truth" in this context refers to engineering and manufacturing specifications:

Biocompatibility: Established by ISO standards.
Software V&V: Established by defined software requirements and FDA guidance.
Bench Testing: Established by the "initial digital scans" and "specifications of the testing" for accuracy.

No clinical outcomes data or expert consensus on patient outcomes is presented as "ground truth" for proving efficacy, as the submission relies on substantial equivalence to a legally marketed predicate device. Animal and human clinical performance testing were explicitly stated as not required for this device category.

8. The sample size for the training set

Not applicable. This is not an AI algorithm that learns from a "training set" in the sense of machine learning for diagnostics. The software (OrthoWare) is a design tool based on existing models and algorithms for tooth movement, not a deep learning system trained on a large dataset of tooth malocclusions.

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

Not applicable (as per point 8).

Summary

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November 4, 2021

Ortho Lab Services, LLC % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K212496

Trade/Device Name: Ortho Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: August 6, 2021 Received: August 9, 2021

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 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

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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 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,

For 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) K212496

Device Name

Ortho Aligner System

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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510(k) SUMMARY – K212496

SUBMITTER
Submitter Name:	Ortho Lab Services, LLC
Submitter Address:	251 Little FallsWilmington, DE 19808
Contact Person:Telephone:	Zuzana Huelsbusch, Regulatory Director0049-1573-0655-886
Date Prepared:	October 28, 2021
DEVICE
Device Trade Name:	Ortho Aligner System
Common Name:	Aligner, Sequential (Clear Braces)
Classification NameNumberProduct CodeRegulatory Class	Orthodontic Plastic Bracket21 CFR 872.5470NXC2
Review Panel	Dental
PREDICATE DEVICE	K172765, Smart Moves Complete, Great Lakes Orthodontics,Ltd.
INDICATIONS FORUSE STATEMENT	The Ortho Aligner System is indicated for the treatment of toothmalocclusion in patients with permanent dentition (i.e. allsecond molars). The Ortho Aligner System positions teeth byway of continuous gentle force.
DEVICEDESCRIPTION	The Ortho Aligner System 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. The aligners areprovided non-sterile and are customized for each patientaccording to the dental practitioner's prescription.
	Physical impressions or digital intraoral scans of the patient'steeth are provided to Ortho Lab Services. A treatment planconsisting of 3D models is created from the impressions orscans, by Ortho Lab Services using the OrthoWare software.Upon approval of the treatment plan by the treating dentalpractitioner using OrthoPortal and issuance of an electronicprescription, the clear aligners are manufactured usingthermoforming methods.
	The finished, customized aligners are shipped based on thedental practitioner's order and confirmed for patient fit anddesign.
	The aligner trays are held in place by pressure and can beremoved by the patient at any time.
MECHANISM OFACTION	Each aligner in sequence applies the pressure (continuousforce) on the teeth targeted to be repositioned in that step.Once the prescribed treatment period is concluded, the next setof aligner trays is used; this continues until the realignment goalhas been met. The patient wears the thermoformed aligners forthe prescribed time in sequence, as monitored and guided bythe clinical/dental practitioner.
SUMMARY OFTECHNOLOGICALCHARACTERISTICS	MaterialsThe thermoplastic materials used for the manufacture of theOrtho Aligners is the same material type which is used to makethe Predicate Smart Moves Complete aligners, a PET-Gthermoplastic sheet.DesignThe subject aligners are designed using similar methods andsimilar design software as the Predicate. Ortho Lab Servicesuses their OrthoWare software, which is similar to the Predicatemanufacturer's Smart Moves Complete 3-D software.Manufacturing ProcessThe process used to manufacture the Ortho Aligner System isthermoforming the material on a model (or mold), the sameprocess method as used by the Predicate device manufacturer.
SAFETY TESTING	Biocompatibility: Testing of the plastic thermoformable materialwas performed for the material supplier by a contract testlaboratory according to Good Laboratory Practices and to meetthe requirements of ISO 10993-1 and Part 5 (Cytotoxicity) andPart 10 (Sensitization).In addition to the material biocompatibility, the submittercontracted to have testing performed according to ISO 10993-5(Cytotoxicity) of the finished thermoformed aligner.All biocompatibility testing passed the test requirements.
PERFORMANCETESTING	Software Verification and Validation TestingSoftware V & V testing, using FDA's guidance document,confirmed acceptance to required specifications.Bench testingTesting to validate the manufacturing process was performed.The test results ensured the accuracy of the final thermoformedaligner compared to the initial digital scans. Aligners met thespecifications of the testing.In vivo Animal and Human ClinicalAnimal and human performance testing are not required for thisdevice category.
COMPARISON TOTHE PREDICATEDEVICE	The Ortho Aligner System has the same intended use as the predicate device.
	There are no fundamental technological differences between the subject and Predicate device. The differences, listed below, do not raise new types of safety and effectiveness questions:• The materials are of the same type: biocompatible PET-G sheets, developed for use by dental device manufacturers for fabricating customized dental appliances, including aligners.
	• The software products used for design of the subject and Predicate devices are different, but have the same purpose and are used in a similar way to design the treatment plans for tooth movement. They both use digital scans to generate images of the final treated states, and intermediate steps to achieve the final state, and convert those files to produce the series of customized aligners.
	• The manufacturing process methods are different but similar: both use standard methods and equipment to thermoform the designed aligners.
CONCLUSION	The conclusions drawn from the side-by-side comparison and the nonclinical testing presented in the 510(k), demonstrate that the subject Ortho Aligner System is as safe and effective, and thus substantially equivalent to, the legally-marketed Smart Moves Complete Predicate.

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Substantial Equivalence Comparison Table

	Subject Device	Predicate DeviceK172765	Comparison
Device Name	Ortho Aligner System	Smart Moves Complete	N/A
Manufacturer	Ortho Lab Services, LLC	Great Lakes Orthodontics Ltd	N/A
ClassificationRegulation #and NameProduct CodeClass	21 CFR 872.5470Orthodontic Plastic BracketNXC2	21 CFR 872.5470Orthodontic Plastic BracketNXC2	Same
Indications forUse	The Ortho Aligner System isindicated for the treatment oftooth malocclusion inpatients with permanentdentition (i.e. all secondmolars). The Ortho AlignerSystem positions teeth byway of continuous gentleforce.	Smart Moves Complete isindicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e.all second molars). SmartMoves Complete positionsteeth by way of continuousgentle force.	Same
Mode of Action	The appliance applies gentleforces on teeth according tothe plan prescribed by thedoctor.	The appliance applies gentleforces on teeth according tothe plan prescribed by thedoctor.	Same
Description ofUse	Each removable preformedplastic tray is worn by thepatient as prescribed by thedoctor, usually a few weeksprior to using the nextsequential aligner tray.	Each removable preformedplastic tray is worn by thepatient as prescribed by thedoctor, usually a few weeksprior to using the nextsequential aligner tray.	Same
Material	Thermoplastic PETG	Thermoplastic PETG	Same material type
ManufacturingProcess	Thermoforming on models	Thermoforming on models	Same process,similar methods
Software Used	Yes, for treatment planningand design of sequentialtrays by Ortho Lab Services.	Yes, for treatment planningand design of sequentialtrays.	Same purposes;Similar software
PrescriptionUse	Rx	Rx	Same
Single PatientUse	Yes	Yes	Same
Biocompatibility	Meets ISO 10993-1, -5, -10requirements: Cytotoxicityand Sensitization/Irritation	Meets ISO 10993-1, -5, -10requirements: Cytotoxicityand Sensitization/Irritation	Same
Process FlowValidationTesting	Performed testing to validatethe finished device matchesthe software output design.	Performed testing to validatethe finished device matchesthe software output design.	Same

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.