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. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.

The aligners, customized for each patient's prescription, are designed and manufactured based on either standard impressions or intraoral scans taken by the dental clinician and which are then sent to the company. The aligners are then sent back to the dental clinician who then distributes them in sequential stages to the patient and follows up with the patient through orthodontic examinations to check device fit and function.

During manufacturing, models are made from physical impressions or intraoral scans. Those made from stone or plaster impressions are scanned into the computer and made into digital files. The intraoral scans arrive as digital files. The digital files are 3D printed and are used to produce the aligner series with the thermoplastic polyurethane.

The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances, including the predicate aligners.

AI/ML Overview

The NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition by positioning teeth through the use of continuous gentle force.

Here's an analysis of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Properties	Aligner material meets specifications for up to 5 years shelf life (according to ASTM D638) for: - Tensile strength (PSI) - Elongation (%) - Tensile @ yield (PSI) - Elongation @ yield (PSI) - Tensile modulus (PSI)	"All testing met the pre-determined acceptance criteria." (Specific numerical results are not provided, only a statement of conformance.)
Packaging Integrity	Aligner material packaging retains the required moisture barrier properties.	"All testing met the pre-determined acceptance criteria." (Specific methodology or results for moisture barrier are not detailed.)
Manufacturing Process Validation	Processes used for the design and manufacture of customized aligners ensure consistency between the aligner's design and the manufactured aligners.	"All testing met the pre-determined acceptance criteria." (Specific details of validation methods or quantitative consistency measures are not provided.)
Biocompatibility (Material)	Thermoplastic polyurethane material tested according to ISO 10993: - 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)	"All testing showed that the material... met the requirements of the test methods and are safe and biocompatible for the stated intended use." (Again, a statement of conformance without specific results.)
Biocompatibility (Finished Device)	Finished customized aligner tested according to ISO 10993, Part 5 (Cytotoxicity).	"Results show it is non-cytotoxic." (Specific details of the cytotoxicity assay or quantitative results are not provided.)

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

The document primarily describes laboratory and bench testing of the device material and manufacturing process and biocompatibility testing.
There is no mention of a "test set" in the context of patient data or clinical performance evaluation for the NEOLab Clear Aligners.
The comparison to the predicate device (ClearCorrect System) is based on technological characteristics and indications for use, not on specific clinical performance data from a test set.
Data provenance: Not applicable as no clinical test set data is described. The performed tests are laboratory-based.

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

Not applicable. The provided document does not describe a clinical study with a test set requiring expert ground truth establishment for diagnostic or treatment efficacy. The testing performed is focused on material properties, manufacturing validation, and biocompatibility.

4. Adjudication method for the test set

Not applicable. No clinical test set.

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 device is a physical medical device (clear aligners), not an AI-powered diagnostic or assistive tool for human readers. There is no AI component or human reader interaction described that would necessitate an MRMC study.

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

Not applicable. This is not an algorithm or software device that would have standalone performance. It is a physical aligner system. While software is used for planning and manufacturing, its performance is not assessed in "standalone" mode in the context of patient outcomes.

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

For the described tests:
- Mechanical properties: The ground truth is established by the specified ASTM D638 standard and internal specifications for tensile strength, elongation, etc.
- Biocompatibility: The ground truth is established by the ISO 10993 series of standards for biological evaluation of medical devices.
- Manufacturing process validation: The ground truth would be the design specifications and expected output consistency of the aligners.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device that requires training data. The device's manufacturing process may involve internal process controls and validation using samples, but these are not referred to as a "training set" in the context of AI.

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

Not applicable, as no training set is described for this device.

Summary

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Thursday, March 12, 2020

New England Ortho Lab, Inc. % Patsy Trisler Regulatory Consultant Oserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K192338

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: February 21, 2020 Received: February 24, 2020

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

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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 Srivinas 'Nandu' Nandkumar, Ph.D. 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter Name:	New England Ortho Lab, Inc.
Submitter Address:	3 Riverside DriveAndover, MA 01810
Phone Number:	1-800-922-6365
Contact Person:	Ms. Olivia ChannonDocument Control Coordinator
Date Prepared:	February 21, 2020
Device Trade Name:	NEOLab Clear Aligners
Common Name	Aligner, Sequential
Classification NameNumberProduct CodeRegulatory Class	Orthodontic Plastic Bracket21 CFR 872.5470NXC2
Primary PredicateDevice:	K113618, ClearCorrect System, ClearCorrect, LLC
Reference Devices:	K152086, Ortho System™, 3Shape A/SK180941, Ortho System™ , 3Shape A/S
Indications for UseStatement	NEOLab Clear Aligners are indicated for the treatment of toothmalocclusions in patients with permanent dentition (i.e. all secondmolars). The NEOLab Clear Aligners position teeth through theuse of continuous gentle force.
Device Descriptionand Summary ofTechnologicalCharacteristics	NEOLAB Clear Aligners consist of a series of customized clearplastic removable aligners that are fabricated from a clear, thinthermoformed polyurethane. The aligners are designed togradually move the patient's teeth incrementally, repositioningthem from their original misalignment to a more aligned state.The aligners, customized for each patient's prescription, aredesigned and manufactured based on either standard impressionsor intraoral scans taken by the dental clinician and which are thensent to the company. The aligners are then sent back to thedental clinician who then distributes them in sequential stages tothe patient and follows up with the patient through orthodonticexaminations to check device fit and function.During manufacturing, models are made from physicalimpressions or intraoral scans. Those made from stone or plasterimpressions are scanned into the computer and made into digitalfiles. The intraoral scans arrive as digital files. The digital filesare 3D printed and are used to produce the aligner series with thethermoplastic polyurethane.
The thermoplastic material used for fabrication of the aligners iscommonly used in many dental appliances, including thepredicate aligners.
Mechanism ofAction	Based on the clinician's treatment plan, each aligner is used for adefined period of time to exert gentle force to achieve progressiverealignment of the teeth. This occurs over time until the finalcorrection has been achieved.
Device Testing	Laboratory/Bench TestingTest data were submitted to:assure the mechanical properties of the aligner materialmeet specifications for up to 5 years shelf life (according toASTM D638) - testing included: tensile strength (PSI) elongation (%) tensile @ yield (PSI) elongation @ yield (PSI) tensile modulus (PSI) assure the aligner material packaging retains the requiredmoisture barrier properties; validate the processes used for the design andmanufacture of the customized aligners, to ensureconsistency between the aligner's design and themanufactured aligners. All testing met the pre-determined acceptance criteria.BiocompatibilityThe thermoplastic polyurethane used for making the aligner serieshas been tested according to Good Laboratory Practices for itsbiocompatibility 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 toISO 10993, Part 5, Cytotoxicity. Results show it is non-cytotoxic.All testing showed that the material and manufactured aligner metthe requirements of the test methods and are safe andbiocompatible for the stated intended use.
	Animal Human TestingNeither animal nor human testing are required for this productbecause it is composed of the same materials, is designedsimilarly, and is manufactured by a similar method as the predicatedevice.
Comparison toPredicate Device:	There are no notable differences comparing the NEOLab clearaligner to the ClearCorrect predicate device:The intended use is the same. The mechanism of action is similar. The polyurethane 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 manufacturing are similar. Refer to the Substantial Equivalence Comparison table below for aside-by-side comparison of the indications for use, technologicalcharacteristics, materials and principles of operation.
SubstantialEquivalenceConclusion:	As presented in the 510(k) and summarized herein, it can beconcluded that NEOLab Clear Aligner is substantially equivalent tothe predicate device.

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Trade Name:	NEOLab Aligner System	ClearCorrect System
510(k) Number	K1923338	K113618
Manufacturer	New England Ortho Lab, Inc.	ClearCorrect, LLC
Classification # &Product CodeClass	21 CFR 852.5470NXC2	21 CFR 852.5470NXC2
Indications forUse	NEOLab Clear Aligners areindicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e. allsecond molars). The NEOLabClear Aligners position teeth byway of continuous gentle force.	The ClearCorrect System isindicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e. allsecond molars). The ClearCorrect System positions teeth byway of continuous gentle force.
Mode of Action	Alignment of teeth byapplication of continuous gentleforce, by sequential use ofpreformed plastic trays.	Alignment of teeth by applicationof continuous gentle force, bysequential use of preformedplastic trays.
Method of Use	Each preformed plastic tray isworn by the patient asprescribed by the dentalpractitioner, usually a fewweeks prior to using the nextsequential aligner tray.	Each preformed plastic tray isworn by the patient as prescribedby the dental practitioner, usuallya few weeks prior to using thenext sequential aligner tray.
Material	Thin thermoformedpolyurethane	Thin thermoformed polyurethane
Biocompatible	Yes	Yes
OTC or Rx	Rx	Rx
Software Use	Yes	Yes
Sterile	No	No

Substantial Equivalence Comparison

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.