The Arcad SmileStudio is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

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

The use of the Arcad SmileStudio and Aligner System requires the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

Device Description

The Arcad SmileStudio software is an orthodontic diagnosis and treatment simulation software for use by dental professionals. SmileStudio imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.

The Arcad Aligner System is 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.

ArcadLab manufactures the customized aligners based on either standard impressions or intraoral scans sent to the company by the prescribing dentist or orthodontist. Arcadlab manufactures models from the impressions and those models are scanned using standard validated software. The digital files are used to produce the aligner series with the thermoplastic polyurethane.

The packaged aligners are sent 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.

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

AI/ML Overview

Acceptance Criteria and Study for Arcad SmileStudio and Aligner System (K192244)

The provided document describes the Arcad SmileStudio and Aligner System, an orthodontic diagnosis and treatment simulation software, along with customized clear plastic aligners. The submission mainly focuses on demonstrating substantial equivalence to predicate devices for FDA clearance, rather than presenting a standalone study with detailed performance metrics and acceptance criteria for an AI component.

Based on the information provided, it's not possible to generate a table of acceptance criteria and reported device performance for an AI component with specific quantitative metrics. The document primarily focuses on the "Arcad SmileStudio software" as an "orthodontic diagnosis and treatment simulation software" and "Arcad Aligner System" as a physical aligner system. While the software provides tools for "systematic inspection, detailed analysis, treatment simulation and virtual design," the document does not mention or quantify any AI components within this software, nor does it define specific performance acceptance criteria for such components.

Therefore, the following responses are based on what can be inferred from the provided text, acknowledging the limitations in scope regarding AI-specific evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, the document does not specify quantitative acceptance criteria or detailed performance metrics for any AI components. The "device testing" section primarily mentions validation processes for design and manufacture of aligners and testing for the SmileStudio software in general, without isolating or quantifying AI performance. The overall "Substantial Equivalence Conclusion" implies that the device performs similarly to its predicates, which is a qualitative assessment for regulatory purposes rather than a detailed performance report.

Therefore, a table cannot be constructed with the requested information from the provided text.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for a test set related to the performance of the Arcad SmileStudio software (or any potential AI components within it). It only mentions "Test data were submitted to validate the processes used for the design and manufacture of the clear customized aligners" and "Testing to verify and validate the Arcad SmileStudio software was included in the premarket notification." The provenance of any such data (e.g., country of origin, retrospective/prospective) is also not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for any test set, particularly concerning any software or AI performance. The "Indications for Use" statement emphasizes that "The use of the Arcad SmileStudio and Aligner System requires the user to have the necessary training and domain knowledge in the practice of orthodontics," implying expert involvement in the use of the system rather than in validating its performance with ground truth.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) for a test set is described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers improving with AI assistance versus without AI assistance. The focus is on demonstrating substantial equivalence to predicate devices, not on comparative effectiveness studies involving AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document does not explicitly state whether a standalone (algorithm only) performance study was conducted. Given the description of the Arcad SmileStudio as a "medical front-end device providing tools" and emphasizing the need for user training and domain knowledge, it suggests a human-in-the-loop system rather than a purely standalone algorithm.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for any testing of the Arcad SmileStudio software or its potential AI components. Terms like expert consensus, pathology, or outcomes data are not mentioned in relation to performance evaluation.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is consistent with the lack of explicit mention or details about AI components within the software.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, there is no information on how its ground truth might have been established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 11, 2020

ArcadLab % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K192244

Trade/Device Name: Arcad SmileStudio and Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC, PNN Dated: April 3, 2020 Received: April 6, 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.

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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 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 Srinivas "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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192244

Device Name

Arcad SmileStudio and Aligner System

Indications for Use (Describe)

The use of the Arcad Aligner System and SmileStudio requires the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

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:	ArcadLab, LLC
Submitter Address:	1860 Old Okeechobee Road, Suite 402West Palm Beach, FL 33409
Email Address:	ecano@arcadlab.com
Contact Person:	Emerson CanoPresident
Date Prepared:	April 3, 2020
Device Trade Name:	Arcad SmileStudio and Aligner System
Common Name	Aligner, Sequential
Predicate Devices	Predicate A	Predicate B
Classification Name	Orthodontic Software	Orthodontic Plastic Bracket
Number	21 CFR 872.5470	21 CFR 872.5470
Product Code	PNN	NXC
Regulatory Class	2	2
Predicate Name	K180941, 3Shape OrthoSystem™; 3Shape A/S	K113618, ClearCorrectSystem, ClearCorrect, LLC
Reference Device	K080227, OrthoCAD iQ; Cadent, Inc.
Indications for UseStatement:	The Arcad SmileStudio is intended for use as a medical front-enddevice providing tools for management of orthodontic models,systematic inspection, detailed analysis, treatment simulation andvirtual design of a series of dental casts, which may be used forsequential aligner trays or retainers, based on 3D models of thepatient's dentition before the start of an orthodontic treatment. Itcan also be applied during the treatment to inspect and analyzethe progress of the treatment. It can be used at the end of thetreatment to evaluate if the outcome is consistent with theplanned/desired treatment objectives.The Arcad Aligner System is indicated for the treatment of toothmalocclusion in patients with permanent dentition (i.e. all secondmolars). The Arcad Aligner System positions teeth by way ofcontinuous gentle force.The use of the Arcad SmileStudio and Aligner System requiresthe user to have the necessary training and domain knowledge inthe practice of orthodontics, as well to have received a dedicatedtraining in the use of the software.
Device Descriptionand Summary ofTechnologicalCharacteristics	The Arcad SmileStudio software is an orthodontic diagnosis andtreatment simulation software for use by dental professionals.SmileStudio imports patient 3-D digital scans and allows the userto diagnose the orthodontic treatment needs of the patient anddevelop a treatment plan. The output of the treatment plan may

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	be downloaded as files in standard stereolithographic (STL)
	format for fabrication of dental casts, which may be used to
	fabricate sequential aligner trays or retainers.

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

Mechanism of Action Based on the clinician's treatment plan, each aligner is used for a prescribed period of time to exert gentle force to achieve the realignment of teeth over a period of time.

Device Testing Laboratory Testing

Test data were submitted to validate the processes used for the design and manufacture of the clear customized aligners.

Testing to verify and validate the Arcad SmileStudio software was included in the premarket notification.

Biocompatibility

The following ISO 10993 testing was performed according to Good Laboratory Practices to assess the safety and biocompatibility of the thermoplastic material:

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)

This testing has shown that the material is safe and biocompatible for the stated intended use.

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Animal | Human Testing

No animal or human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by method similar to the predicate device.

Comparison to There are no notable differences comparing the Arcad aligner Predicate Devices: system to the ClearCorrect aligner and 3Shape software predicate devices (see SE Comparison Table below):

The intended use is the same. .
. The mechanisms of action (software and aligner systems) are the same.
. The polyurethane material used to make the aligners is the same.
. The method of manufacture and customizing the aligners is similar.
. The software used during the planning and manufacturing processes is similar.

Substantial Based on the documentation presented in the 510(k), as Equivalence summarized above and shown on the SE Comparison Table, it Conclusion can be concluded that this software system and the clear aligners are substantially equivalent to the predicate devices.

Trade Name:	Arcad Lab Aligner and Arcad Smile Studio		Predicate A3Shape Ortho System	Predicate BClearCorrect System™
510(k) #	K192244		K180941	K113618
Manufacturer	ArcadLab, LLC		3Shape A/S	ClearCorrect, LLC
Classification name21 CFRProduct CodeClass	Orthodonticplasticbracket852.5470NXC2	OrthodonticSoftware -852.5470PNN2	Orthodontic software852.5470NXC2	Orthodontic plasticbracket852.5470PNN2
Intended Use	The ArcadLab SmileStudio isintended for use as a medicalfront-end device providing toolsfor management of orthodonticmodels, systematic inspection,detailed analysis, treatmentsimulation and virtual design ofa series of dental casts, whichmay be used for sequentialaligner trays or retainers, basedon 3D models of the patient'sdentition before the start of anorthodontic treatment.It can also be applied during thetreatment to inspect and		Ortho System™ for dentalretainers and dental casefor sequential aligners isintended for use as amedical front-end deviceproviding tools formanagement of orthodonticmodels, systematicinspection, detailedanalysis, treatmentsimulation and virtualappliance design optionsbased on 3D models of thepatient's dentition beforethe start of an orthodontictreatment.	The ClearCorrectSystem is indicated forthe treatment of toothmalocclusion in patientswith permanent dentition(i.e. all second molars).The Clear CorrectSystem positions teethby way of continuousgentle force.

	analyze the progress of thetreatment. It can be used at theend of the treatment to evaluateif the outcome is consistent withthe planned/desired treatmentobjectives.The ArcadLab Aligner Systemis indicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e. allsecond molars). The ArcadLabAligner System positions teethby way of continuous gentleforce.The use of the ArcadLabSmileStudio and AlignerSystem requires the user tohave the necessary training anddomain knowledge in thepractice of orthodontics, as wellto have received a dedicatedtraining in the use of thesoftware.	The use of the OrthoSystem™ requires the userto have the necessarytraining and domainknowledge in the practice oforthodontics, as well as tohave received a dedicatedtraining in the use of thesoftware.	The ClearCorrectSystem is indicated forthe treatment of toothmalocclusion in patientswith permanent dentition(i.e. all second molars).The Clear CorrectSystem positions teethby way of continuousgentle force.
Mode ofAction ofcustomizedaligner	Alignment of teeth byapplication of continuous gentleforce, by sequential use ofpreformed plastic trays.	N/A	Alignment of teeth byapplication of continuousgentle force, bysequential use ofpreformed plastic 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.The software is used by DentalProfessionals in orthodontictreatment planning (before,during, after treatment)covering management ofpatients and models,inspection, 2D and 3Dmeasurement, orthodonticanalysis of models, 2D & 3Dtreatment simulation, as wellas virtual appliancepreparation, handling andexport. Also provides CAMoutput for 3D printers andmilling machines.	The software is used byDental Professionals inorthodontic treatmentplanning (before, during,after treatment) coveringmanagement of patientsand models, inspection, 2Dand 3D measurement,orthodontic analysis ofmodels, 2D & 3D treatmentsimulation, as well as virtualappliance preparation,handling and export. Alsoprovides CAM output for 3Dprinters and millingmachines.	Each preformed plastictray is worn by thepatient as prescribed bythe dental practitioner,usually a few weeksprior to using the nextsequential aligner tray.
Material	Thin thermoformedpolyurethane	N/A	Thin thermoformedpolyurethane
Biocompatible	Yes	N/A	Yes
OTC or Rx	Rx	Rx	Rx
Software	Yes – system includessoftware	Yes - product is software	No - system does notinclude software

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Submitter: ArcadLab, LLC

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.