NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use of continuous gentle force.

Device Description

NEOLab Clear Aligners consist of a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane-polyester resin, and are intended to be worn 22 hours a day. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.

AI/ML Overview

The provided document (K203339) is a Special 510(k) summary for the NEOLab Clear Aligners. It focuses on demonstrating substantial equivalence to a predicate device (Ormco Spark Aligner System, K182826) by showing that the new device has the same intended use, similar technological characteristics, and meets material and manufacturing specifications.

However, this document does NOT describe the acceptance criteria and the study that proves a device (e.g., an AI-powered device or a diagnostic device) meets specific performance criteria through a clinical or algorithmic performance study.

The testing described in this document is primarily related to:

Mechanical properties of the aligner material: Ensuring it meets specifications for shelf life.
Validation of manufacturing processes: Confirming the custom aligner fabrication.
Biocompatibility testing: According to ISO 10993 standards for the thermoplastic polyurethane-polyester resin and the finished aligner.

There is no mention of a study involving:

A test set of data (e.g., medical images, patient records).
Any form of algorithm performance evaluation (e.g., accuracy, sensitivity, specificity, AUC).
Human expert readers establishing ground truth.
Multi-reader multi-case (MRMC) studies.
Effect sizes of human reader improvement with AI assistance.
Stand-alone algorithm performance.

Therefore, I cannot populate the requested table and information based on the provided text, as the document does not contain the study details you are asking for.

The document states:

"Test data were submitted to: Assure the aligner mechanical properties of the aligner material meet specifications for up to 5 years shelf life; Validate the processes used for the design and manufacture of the customized aligners."
"Biocompatibility: The thermoplastic polyurethane-polyester resin used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993..."
"This testing showed that the material and manufactured aligner met the acceptance criteria, passed the respective tests, and are safe and biocompatible for the stated intended use."

This indicates that acceptance criteria existed for the material properties and biocompatibility, but these are not performance metrics for a diagnostic or AI device that interacts with patient data in the way implied by your questions about ground truth, expert readers, and test sets.

To fulfill your request, the document would need to describe a study evaluating the performance of a device, for example, an AI algorithm that analyzes orthodontic scans, or a diagnostic tool. Since this is a 510(k) for physical clear aligners, the type of performance evaluation differs significantly.

Summary

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January 6, 2021

New England Ortho Lab, Inc Olivia Channon Document Control Coordinator 3 Riverside Drive Andover, Massachusetts 01810

Re: K203339

Trade/Device Name: NEOLab Clear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: December 7, 2020 Received: December 7, 2020

Dear Olivia Channon:

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,

For Michael Adjodha 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) K192338

Device Name NEOLab Clear Aligners

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Residential Use (Part 21 CFR 601 Subpart E)
Over-The-Counter Use (21 CFR 601

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Premarket Notification: Special 510(k) Submitter: New England Ortho Lab, Inc (NEOLab) NEOLab Clear Aligners, K203339 NXC, Class II Dental

Special 510(k) Summary

Submitter Name	New England Ortho Lab, Inc
Submitter Address	3 Riverside DrAndover, MA 01810
Phone Number	+1 (800) 922 - 6365
Contact Person	Ms. Olivia ChannonDocument Control Coordinatorolivia@neolab.com
Date Prepared	December 2, 2020
Device Trade Name	NEOLab Clear Aligners
Common Name	Aligner, Sequential
Classification NameNumberProduct CodeRegulatory Class	Orthodontic Plastic Bracket21 CFR 872.5470NXCII
Primary PredicateDevice	K182826, Ormco™ Spark™ Aligner System, Sybron Dental Specialties
Reference Devices	K152086, Ortho System™, 3Shape A/SK180941, Ortho System™, 3Shape A/S
Statement of IntendedUse	NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions inpatients with permanent dentition (i.e. all second molars). The NEOLab Clear Alignersposition teeth through the use of continuous gentle force.
Device Description andSummary ofTechnologicalCharacteristics	NEOLab Clear Aligners consist of a series of customized clear plastic removablealigners that are fabricated from a clear, thin thermoformed polyurethane-polyesterresin, and are intended to be worn 22 hours a day. The aligners are designed togradually move the patient's teeth incrementally, repositioning them from theiroriginal misalignment to a more aligned state.

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patient in sequential stage, and confirms fit and functions and monitors the patient through the entire course of aligner therapy. This summary of technological characteristics is unchanged from the predicate device.

Mechanism of Action Based on the clinician's treatment plan, each aligner is used for a defined period of time to exert gentle force to achieve progressive realignment of the teeth. This occurs over time until the final correction has been achieved.

Device Testing Laboratory Testing

Test data were submitted to:

Assure the aligner mechanical properties of the aligner material meet specifications for up to 5 years shelf life;
Validate the processes used for the design and manufacture of the customized aligners.

Biocompatibility

The thermoplastic polyurethane-polyester resin used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows:

Part 3 (Bacterial Mutagenicity Ames Assay) ●
Part 5 (Cytotoxicity Elution - MEM)
Part 10 (Intracutaneous/Intradermal Reactivity) ●
Part 10 (Oral Mucosa Irritation)
Part 10 (Maximization for Delayed-Type Hypersensitivity)
Part 11 (Subacute Systemic Toxicity)

Further, the finished customized aligner was tested according to ISO 10993, Part 5, Cytotoxicity. Results show it is non-cytotoxic.

This testing showed that the material and manufactured aligner met the acceptance criteria, passed the respective tests, and are safe and biocompatible for the stated intended use.

There are no notable differences comparing the NEOLab Clear Aligner to the Ormco™ Comparison to Predicate Device Spark™ Aligner System predicate device:

The intended use is the same; ●
The mechanism of action is similar;
The polyurethane-polyester material used to make the aligners is the same; ●
The method of manufacture and customizing the aligners is similar;
The use of software for planning and manufacture is similar.

Substantial Based on the documentation presented in this Special 510(k), as summarized above, it can be concluded that NEOLab Clear Aligners are substantially equivalent to the Equivalence Conclusion predicate device.

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Trade Name	NEOLab Clear Aligners	Ormco™ Spark™ Aligner System
510(k) Number	K203339	K182826
Submission	Special 510(k)	Traditional 510(k)
Manufacturer	New England Ortho Lab, Inc	Sybron Dental Specialties
Classification No.	21 CFR 852.5470	21 CFR 852.5470
Product Code	NXC	NXC
Class	II	II
Indications for Use	NEOLab Clear Aligners are indicated forthe treatment of tooth malocclusion inpatients with permanent dentition (i.e.all second molars). The NEOLab ClearAligners position teeth by way ofcontinuous gentle force.	The Ormco™ Spark™ Aligner System isindicated for the alignment of teethduring orthodontic treatment ofmalocclusion in patients with permanentdentition (i.e. all second molars). TheOrmco™ Spark™ Aligner System positionsteeth by way of continuous gentle force.
Mode of Action	Alignment of teeth by application ofcontinuous gentle force, by sequentialuse of preformed plastic trays,fabricated based on doctor'sprescription.	Orthodontic tooth movement occursthrough forces applied by the appliance tothe dentition as each tooth follows theprogrammed displacement based on thedoctor's prescription.
Process andMethod of Use	Scans and prescription are sent toNEOLab by the doctor. Treatment isplanned by NEOLab, and reviewed andapproved by doctor. Aligners arefabricated and shipped to doctor. Eachpreformed plastic tray is worn by thepatient as prescribed by the dentalpractitioner.	Doctor uploads patient's dental scans intoproprietary software; doctor usessoftware for case viewing and treatmentplanning; Ormco technician receives caseand uses proprietary 3D software togenerate models or the aligners based onthe prescription (desired outcome);Doctor approves treatment plan and finaltreated state; manufacturer crafts andproduces aligners; aligners and ships themto doctor, who them provides them to thepatient, confirming fit and design.
Material	Thermoplastic polyurethane-polyestercomposite resin	Thermoplastic polyurethane-polyestercomposite resin
Biocompatible	Yes	Yes
OTC or Rx	Rx	Rx
Software Use	Yes	Yes
Sterile	No	No

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.