(266 days)
No
The summary does not mention AI, ML, or any related terms in the device description, intended use, or performance studies. The software is described as a "diagnosis and treatment simulation software" that allows the user to "diagnose" and "develop a treatment plan," implying user-driven processes rather than automated AI/ML analysis.
Yes
The Arcad Aligner System, which is part of this device, is indicated for the treatment of tooth malocclusion by gradually moving teeth incrementally, repositioning them to a more aligned state, which is a therapeutic action.
Yes
The "Device Description" explicitly states, "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."
No
The device description clearly states that the "Arcad Aligner System is a series of customized clear plastic removable aligners" which are physical devices fabricated from thermoplastic polyurethane. While the Arcad SmileStudio software is a component, the overall system includes hardware (the aligners).
Based on the provided information, the Arcad SmileStudio and Arcad Aligner System are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Arcad SmileStudio and Aligner System work with 3D digital scans or impressions of the patient's dentition. While these are derived from the patient, they are physical representations or digital models of the teeth, not biological specimens like blood, urine, or tissue that are analyzed for diagnostic information about a disease or condition.
- The intended use is for orthodontic diagnosis, treatment simulation, and the fabrication of aligners. This is a process related to the physical alignment of teeth, not the diagnosis of a disease or condition through the analysis of biological samples.
- The device description focuses on software for treatment planning and the fabrication of physical aligners. There is no mention of analyzing biological markers or performing tests on bodily fluids or tissues.
The Arcad SmileStudio and Aligner System fall under the category of dental devices used for orthodontic treatment.
N/A
Intended Use / Indications for Use
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 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.
Product codes
NXC, PNN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
permanent dentition (i.e. all second molars)
Intended User / Care Setting
dental professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 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 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 402 | |
| West Palm Beach, FL 33409 | ||
| Email Address: | ecano@arcadlab.com | |
| Contact Person: | Emerson Cano | |
| President | ||
| 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 Ortho | |
| System™; 3Shape A/S | K113618, ClearCorrect | |
| System, ClearCorrect, LLC | ||
| Reference Device | K080227, OrthoCAD iQ; Cadent, Inc. | |
| Indications for Use | ||
| Statement: | 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 user to have 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
and Summary of
Technological
Characteristics | 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 | |
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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 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.
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 A
3Shape Ortho System | Predicate B
ClearCorrect System™ |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K192244 | | K180941 | K113618 |
| Manufacturer | ArcadLab, LLC | | 3Shape A/S | ClearCorrect, LLC |
| Classification name
21 CFR
Product Code
Class | Orthodontic
plastic
bracket
852.5470
NXC
2 | Orthodontic
Software -
852.5470
PNN
2 | Orthodontic software
852.5470
NXC
2 | Orthodontic plastic
bracket
852.5470
PNN
2 |
| Intended Use | The ArcadLab 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 | | Ortho System™ for dental
retainers and dental case
for sequential aligners 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
appliance design options
based on 3D models of the
patient's dentition before
the start of an orthodontic
treatment. | The ClearCorrect
System is indicated for
the treatment of tooth
malocclusion in patients
with permanent dentition
(i.e. all second molars).
The Clear Correct
System positions teeth
by way of continuous
gentle force. |
| | | | | |
| | 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 ArcadLab Aligner System
is indicated for the treatment of
tooth malocclusion in patients
with permanent dentition (i.e. all
second molars). The ArcadLab
Aligner System positions teeth
by way of continuous gentle
force.
The use of the ArcadLab
SmileStudio and Aligner
System requires the user to
have 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. | The use of the Ortho
System™ requires the user
to have the necessary
training and domain
knowledge in the practice of
orthodontics, as well as to
have received a dedicated
training in the use of the
software. | The ClearCorrect
System is indicated for
the treatment of tooth
malocclusion in patients
with permanent dentition
(i.e. all second molars).
The Clear Correct
System positions teeth
by way of continuous
gentle force. | |
| Mode of
Action of
customized
aligner | Alignment of teeth by
application of continuous gentle
force, by sequential use of
preformed plastic trays. | N/A | Alignment of teeth by
application of continuous
gentle force, by
sequential use of
preformed plastic trays. | |
| Method of Use | Each preformed plastic tray is
worn by the patient as
prescribed by the dental
practitioner, usually a few
weeks prior to using the next
sequential aligner tray.
The software is used by Dental
Professionals in orthodontic
treatment planning (before,
during, after treatment)
covering management of
patients and models,
inspection, 2D and 3D
measurement, orthodontic
analysis of models, 2D & 3D
treatment simulation, as well
as virtual appliance
preparation, handling and
export. Also provides CAM
output for 3D printers and
milling machines. | The software is used by
Dental Professionals in
orthodontic treatment
planning (before, during,
after treatment) covering
management of patients
and models, inspection, 2D
and 3D measurement,
orthodontic analysis of
models, 2D & 3D treatment
simulation, as well as virtual
appliance preparation,
handling and export. Also
provides CAM output for 3D
printers and milling
machines. | Each preformed plastic
tray is worn by the
patient as prescribed by
the dental practitioner,
usually a few weeks
prior to using the next
sequential aligner tray. | |
| Material | Thin thermoformed
polyurethane | N/A | Thin thermoformed
polyurethane | |
| Biocompatible | Yes | N/A | Yes | |
| OTC or Rx | Rx | Rx | Rx | |
| Software | Yes – system includes
software | Yes - product is software | No - system does not
include software | |
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Submitter: ArcadLab, LLC