Orthodent Laboratory, Inc. Vivid Aligner are intraoral thermoformed plastic aligner 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 aligner are to be removed for eating and for cleaning. Orthodent Laboratory, Inc. Vivid Aligner 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, Orthodent Laboratory 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. The treatment plan is sent to the doctor for approval. Upon approval, 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

This document describes the 510(k) premarket notification for the Vivid Aligner by Orthodent Laboratory, Inc. This submission seeks to establish substantial equivalence to existing legally marketed devices, rather than proving a new device's performance against specific acceptance criteria for a novel technology.

Therefore, many of the requested details regarding acceptance criteria, specific study design for device performance (especially for AI/algorithmic components), and clinical efficacy studies are not applicable to this type of submission. This document primarily focuses on demonstrating that the Vivid Aligner is similar enough to predicate devices in terms of materials, intended use, and general manufacturing process to be considered safe and effective.

Here's an breakdown of the available information based on your request, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not applicable in this context. The submission's goal is to demonstrate "substantial equivalence" to predicate devices, not to meet specific performance metrics for a novel AI or algorithmic device. The "device performance" here is primarily tied to material properties and biocompatibility, not an AI's diagnostic or therapeutic accuracy.

The document states the following device testing:

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Meets ISO 10993 standards: 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).
Non-Clinical Physical Properties	Device material tested to and meets acceptance criteria for:
	• Elongation @ Yield (%) ASTM D638
	• Elongation @ Break (%) ASTM D638
	• Tensile @ Yield (PSI) ASTM D638
	• Tensile Strength (PSI) ASTM D638
	• Tensile Modulus (PSI) ASTM D638
	• Flexural Modulus (PSI) ASTM D790
	• Flexural Strength (PSI) ASTM D790
	• Specific Gravity g.cm3 ASTM D792
	• Water Absorption (%) 24 hours @ 23°C ASTM D570
	• Gardner Impact Strength 23°C J/mm ASTM D5420

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

This information is not provided as there wasn't a "test set" in the context of an AI/algorithmic device performance study. The tests conducted were material property and biocompatibility tests, which would have their own sample sizes for the materials themselves, but these are not disclosed.

Data Provenance: N/A (for AI performance). For material testing, it would be lab-generated data.

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

This information is not applicable. Ground truth establishment by experts (e.g., radiologists) is relevant for diagnostic AI systems. This submission is for orthodontic aligners, where performance is measured by material properties and biocompatibility, not diagnostic accuracy requiring expert panel review.

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

This is not applicable. Adjudication methods are used in studies involving human interpretation or performance evaluation of AI systems.

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

This is not applicable. MRMC studies are relevant for diagnostic devices that assist human readers. The Vivid Aligner is a physical orthodontic device.

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

This is not applicable for the device's primary function. While the device manufacturing involves software (3Shape Software K180491), the submission does not describe standalone performance testing of this software in isolation as if it were a diagnostic AI. The software's role is in treatment planning and model generation for the physical aligners. The submission notes the software is "FDA 510K cleared" and its "use/manufacturing process has been validated by ODL."

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

This is not applicable in the context of diagnostic AI ground truth. For the material testing, the "ground truth" would be established by the standardized test methods (e.g., ASTM, ISO standards) and their defined acceptance criteria for material properties. For biocompatibility, the ground truth is adherence to ISO 10993 testing protocols and passing results.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device that requires a training set for an algorithm.

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

This is not applicable. This is not an AI/ML device that requires a training set for an algorithm.

Summary of Device Acceptance / Substantial Equivalence:

The core of this 510(k) submission for the Vivid Aligner is to demonstrate substantial equivalence to existing predicate devices (K173784 Smylio Invisible Clear Aligner, K173785 Derby Dental, Custom Clear Aligner System, and K182826 Ormco Spark Aligner System).

The "study that proves the device meets the acceptance criteria" (in the context of a 510(k) for this type of device) consisted of:

Biocompatibility Testing: The device's materials were tested according to ISO 10993 standards (Parts 3, 5, 10, 11) and found to be biocompatible. This is a critical "acceptance criterion" for any medical device coming into contact with the patient.
Non-Clinical Physical Properties Testing: The device material was tested against various ASTM standards for properties like elongation, tensile strength, flexural modulus, specific gravity, water absorption, and impact strength, and met the predefined "acceptance criteria" for these material parameters (actual pass/fail thresholds are not detailed in the summary, but it states they "meet the acceptance criteria").
Comparison to Predicate Devices: A detailed comparison table (pages 4-6) was provided to show that:
- The Indications for Use are identical to the predicate.
- The Mode of Action is the same.
- The Method of Use is the same.
- The Material (thin thermoformed polyurethane) is the same.
- It is Biocompatible (as demonstrated by testing).
- It is a Prescription Use device, similar to the predicate.
- It uses Software, and the software used (3Shape K180491) is also FDA 510(k) cleared.
- It is Non-Sterile, like the predicate.
- Minor differences (Orthodent prepares treatment plan vs. doctor, specific 3Shape software version, specific ISO standard citation for biocompatibility) were assessed and deemed to "not affect substantial equivalence or safety and effectiveness."

Conclusion from the Document:

Based on the material testing and the demonstration of substantial equivalence in intended use, technological characteristics, and performance to the predicate devices, the FDA determined that the Vivid Aligner is "substantially equivalent" and may be legally marketed. This process does not involve the in-depth AI-specific performance studies envisioned in many of your questions.

Summary

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November 6, 2019

Orthodent Laboratory, Inc. % Robert Dean President Compliance Systems International, LLC. 1083 Delaware Ave. Buffalo, New York 14209

Re: K190003

Trade/Device Name: Vivid Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 24, 2018 Received: October 8, 2019

Dear Robert Dean:

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,

for Srinivas Nandkumar, Ph.D. Acting 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) K190003

Device Name Vivid Aligner

Indications for Use (Describe)

Vivid Aligner is indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K190003 510(k) Summary

Submitter Name:	Orthodent Laboratory, Inc.
Submitter Address:Phone Number:	166 Chandler St. Suite 301, Buffalo, NY 14207800-837-1552
Contact Person:Date Prepared:	Mr. Michael WrightOctober 29, 2019
Device Trade Name:	Vivid Aligner
Common NameClassification NameNumberProduct CodeRegulatory Class	Aligner, SequentialOrthodontic Plastic Bracket21 CFR 872.5470NXC2
Primary PredicateDevice:Reference PredicateDevices:	K173784, Smylio Invisible Clear AlignerK173785 Derby Dental, Custom Clear Aligner SystemK182826 Ormco Spark Aligner System
Statement ofIndications forUse:	Vivid Aligner is indicated for use in the alignment of permanent teeththrough orthodontic treatment of misalignment and malocclusion.
Device Descriptionand Summary ofTechnologicalCharacteristics:	Orthodent Laboratory, Inc. Vivid Aligner are intraoral thermoformedplastic aligner that are worn 20 to 22 hours per day and are designedto be used in a sequence, each aligner providing a gentle continuousforce, to allow for the movement of teeth to the final desired position.The aligner are to be removed for eating and for cleaning. OrthodentLaboratory, Inc. Vivid Aligner are fabricated using a three-stepprocess. The first step is to obtain the dimensions and details of thepatient's baseline dentition. This is generally done using an oral scandata or a physical impression. This scanned data (digital CAD/CAMmodels or patient models) are imported into specialized dentalsoftware for treatment planning. The second step is the printing of 3Dmodels of the treatment plan for use in step 3 (thermoforming). In thesecond step, Orthodent Laboratory utilizes a software application toplan the treatment by creating a series of sequential models thatgradually position the teeth into their final desired position. Thetreatment plan is sent to the doctor for approval. Upon approval, a 3Dprinter is used to create the molds needed for each treatment step toprovide the surface around which the aligner is thermoformed. Thefinal step is the thermoforming of a plastic sheet material to each of thesequential treatment steps. This process is done using a standardthermoforming equipment and the appropriate material as outlined inthis submission.
Mechanism of Action:	In the same manner as the predicate device, each aligner exertsgentle force to achieve progressive realignment of the teeth untilthe final correction has been attained. This is based on thetreatment plan and proceeds over time.
Device Testing:	BiocompatibilityContact of the device to the patient's oral tissue requires theAligner material to be biocompatible. The thermoplasticpolyurethane has been tested according to Good LaboratoryPractices for its biocompatibility according to ISO 10993, asfollows: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)
Animal Human Testing	No animal or human testing were required for this productbecause it is composed of the same materials and has a similardesign and method of manufacture/fabrication in comparison tothe predicate device.
Non-Clinical PhysicalProperties Testing:	Device material tested to the following standards and meet the acceptancecriteria• Elongation @ Yield (%) ASTM D638• Elongation @ Break (%) ASTM D638• Tensile @ Yield (PSI) ASTM D638• Tensile Strength (PSI) ASTM D638• Tensile Modulus (PSI) ASTM D638• Flexural Modulus (PSI) ASTM D790• Flexural Strength (PSI) ASTM D790• Specific Gravity g.cm3 ASTM D792• Water Absorption (%)24 hours @ 23°C ASTM D570• Gardner Impact Strength 23°C J/mm ASTM D5420,

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Differences between ODL Vivid Aligner compared to
predicate device

ODL Vivid Aligner	S & E Effect	Smylio K173784
ODL prepares the	No effect, both	Smylio K173784 doctor
treatment plan in Step 2 of	treatment plans are	prepares the treatment plan
the manufacturing process	doctor approved.
for subsequent approval by
a doctor.

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ODL uses 3Shape SoftwareK180491	No effect, 3ShapeSoftware K180491 isFDA 510K cleared, theuse/manufacturingprocess has beenvalidated by ODL	Smylio uses 3Shape SoftwareK152086
ODL biocompatibilitysummary applied ISO10993• -3, Biological evaluationof medical devices — Part3: Tests for genotoxicity,carcinogenicity andreproductive toxicity• -5, Biological evaluationof medical devices — Part5: Tests for in vitrocytotoxicity• -10, Biological evaluationof medical devices -- Part10: Tests for irritation andskin sensitization• -11, Biological evaluationof medical devices — Part11: Tests for systemictoxicity	No effect onbiocompatibility. ISO7405 directlyreferences the sametest as conductedusing ISO 10993 et.al.	Smylio biocompatibilitysummary references ISO7405, Dentistry - Evaluationof biocompatibility ofmedical devices used indentistry

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Trade Name:	Submission DeviceOrthodent Laboratory, Inc.Vivid Aligner	Predicate DeviceK173784Smylio Invisible Clear Aligner
510(k) Number		K173785
Manufacturer	Orthodent Laboratories Inc.	Smylio
Classification #,Product CodeDevice Class	21 CFR 852.5470NXC 2	21 CFR 852.5470NXC 2
Indications for Use	Vivid Aligner is indicated for use in thealignment of permanent teeth throughorthodontic treatment of misalignment andmalocclusion.	Smylio Invisible Clear Aligner is indicatedfor use in the alignment of permanentteeth through orthodontic treatment ofmisalignment and malocclusion.
Mode of Action	Alignment of teeth by application ofcontinuous gentle force, by sequential useof preformed plastic trays.	Alignment of teeth by application ofcontinuous gentle force, by sequential useof preformed plastic trays.
Method of Use	Each preformed plastic tray is worn bythe patient as prescribed by the dentalpractitioner, usually a few weeks prior tousing the next sequential Aligner tray.	Each preformed plastic tray is wornby the patient as prescribed by thedental practitioner, usually a fewweeks prior to using the nextsequential Aligner tray.
Material	Thin thermoformedpolyurethane	Thin thermoformedpolyurethane
Biocompatible	Yes	Yes
OTC or Rx	Rx	Rx
Software Use	Yes	Yes
Sterile	No	No

The intended use of the Orthodent Laboratory, Inc. Vivid Aligner is the same to that of the primary predicate device as they are both intended for correcting dental malocclusion in patients with permanent dentition.

It has a similar technological principle, and the device characteristics are similar to the predicate device. The mode of operation and the material used to fabricate the aligner trays is the same as the predicate device. There are minor differences comparing Orthodent Laboratory, Inc. Vivid Aligner to the predicate Smylio Invisible Clear Aligner which do affect substantial equivalence or safety and effectiveness.

Substantial Equivalence Conclusion

Thus, based on the above it can be concluded that Orthodent Laboratory, Inc. Vivid Aligner is substantially equivalent to the predicate device.

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.