(63 days)
Titan Dental Design 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 (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) 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 use of Titan Dental Design 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.
Titan Dental Design by ClearAdvance, LLC is an orthodontic appliance design and treatment planning software. This software is for use by dentists, orthodontists, and trained health care professionals to diagnose and design treatment solutions for patients. The Titan Dental Design software allows users to upload digital scans of patient's dentition to the system, manipulate and move teeth in the dentition scan to create treatment plans for malocclusion, and export or send treatment planning files for physical production of orthodontic appliances such as thermoplastic aligners with the use of 3D printers.
The provided text is a 510(k) summary for the "Titan Dental Design" software. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a specific study, especially not one that involves human readers or clinical outcomes.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and performance metrics (especially those related to AI assistance or standalone performance) are not present in this document.
This document describes a software device that provides tools for managing orthodontic models, systematic inspection, detailed analysis, treatment simulation, and virtual appliance design options. It is not an AI-assisted diagnostic tool in the sense of detecting or identifying conditions from medical images, which is typically where the detailed performance metrics you've asked for (e.g., sensitivity, specificity, MRMC studies) are most relevant. This software is more of a design and planning tool for orthodontists.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of quantitative acceptance criteria for performance metrics (such as sensitivity, specificity, or precision), nor does it report specific numerical performance data against these criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing indications for use, technological characteristics, and stating that software validation testing was successfully performed.
The "Summary of Performance Data and Substantial Equivalence" section states:
"Utilizing FDA Guidance document 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (issued May 11, 2015) the Proposed Device, Titan Dental Design underwent appropriate integration, verification, and validation testing. The software passed the testing and performed per its intended use."
This is the reported "performance" - a qualitative statement confirming it "passed testing" and "performed per its intended use," rather than specific quantitative metrics.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of any data used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a "ground truth" for a test set, as its validation appears to be primarily software-centric (integration, verification, validation) rather than based on a clinical performance study with human readers.
4. Adjudication method for the test set
Not applicable, as no clinical test set with human adjudication is described.
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
No such study is mentioned or implied. This device is described as a "medical front-end device providing tools for management... treatment simulation and virtual appliance design options," not an AI-assisted diagnostic tool that aids human readers in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes the device as "Stand Alone Software" under "Technological Features," but this refers to the software's operational independence (i.e., it doesn't require other specific hardware or software beyond OS/RAM/CPU) rather than a "standalone performance study" in the context of an AI algorithm's diagnostic accuracy. The entire device functions as "algorithm only" in the sense that it is software, but performance data like sensitivity/specificity are not provided.
7. The type of ground truth used
Not explicitly stated. The validation appears to be against functional requirements and intended use, rather than a clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
The document does not mention a training set size, implying that this is not a machine learning model that requires a distinct "training set." It's more of a rule-based or calculational software tool for dental design.
9. How the ground truth for the training set was established
Not applicable, as no training set or machine learning components are detailed.
In summary, the provided FDA document is a 510(k) clearance letter and summary for a dental software device that functions as a design and planning tool, not an AI-driven diagnostic or assistive technology. Therefore, it does not contain the detailed performance study information typically found in submissions for AI/ML-based diagnostic devices, such as acceptance criteria based on accuracy metrics, test set characteristics, expert ground truthing, or MRMC study results.
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October 13, 2023
ClearAdvance, LLC % Logan Simmons Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043
Re: K232429
Trade/Device Name: Titan Dental Design Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: August 11, 2023 Received: August 11, 2023
Dear Logan Simmons:
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 (the 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 available 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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2 K232429 - Logan Simmons
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
MichaeFE. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT 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)
K232429
Device Name Titan Dental Design
Indications for Use (Describe)
Titan Dental Design 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 (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) 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 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 use of Titan Dental Design 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.
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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Section 5. 510(k) Summary
K232429
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information for this traditional 510(k) in accordance with the requirements of 21 CFR 807.92.
| Submitter: | CLEARADVANCE, LLC18 ENDEAVOR, STE 107IRVINE, CA 92618 |
|---|---|
| Company Contact Person: | Frank Puig, Co-Founder, ClearAdvance, LLC |
| Phone: | 614-260-9849 |
| Email: | Frank.Puig@gmail.com |
| Submission Correspondent: | Logan Simmons, Regulatory Affairs Consultant |
| Address: | 1321 Upland Dr. Suite 6792 Houston, TX 77043 |
| Phone: | 440-387-9788 |
| Email: | lsimmons@primepathmedtech.com |
| Date Prepared: | August 1, 2023 |
| Proprietary Name: | Titan Dental Design |
| Common Name: | Orthodontic Plastic Bracket (Software) |
| Product Code: | PNN – Orthodontic plastic bracket (Software), LLZ |
| Device Classification: | Class II, 21 CFR 872.5470 |
| Primary Predicate Device: | 3Shape Ortho System (K152086) |
| Second Predicate Device: | Brius Planner Software (K212828) |
Device Description:
Titan Dental Design by ClearAdvance, LLC is an orthodontic appliance design and treatment planning software. This software is for use by dentists, orthodontists, and trained health care professionals to diagnose and design treatment solutions for patients. The Titan Dental Design software allows users to upload digital scans of patient's dentition to the system, manipulate and move teeth in the dentition scan
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to create treatment plans for malocclusion, and export or send treatment planning files for physical production of orthodontic appliances such as thermoplastic aligners with the use of 3D printers.
Indications for Use:
Titan Dental Design 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 (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) 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 use of Titan Dental Design 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.
Comparison to Predicate Devices:
The Proposed Device is functionally equivalent to the following devices: 3Shape Ortho System (K152086, cleared April 28, 2016) and Brius Planner Software (K212828, cleared 10/01/2021). The following table demonstrates the functional specifications of the Proposed Device are substantially equivalent to the Predicate Devices and raises no questions regarding safety and effectiveness of the device.
| Specification | Proposed Device:Titan Dental Design | Primary PredicateDevice:3Shape OrthoSystem (K152086) | Predicate Device:BRIUS PlannerSoftware (K212828) | ComparisonResult |
|---|---|---|---|---|
| Regulation Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification Name | Orthodontic PlasticBracket (Software) | Orthodontic PlasticBracket (Software) | Orthodontic PlasticBracket | Same |
| Product Code | PNN, LLZ | PNN, LLZ | PNN | Same |
| Classification | Class II | Class II | Class II | Same |
| Indication for Use | Titan DentalDesign...is intended for useas a medical front-end device providingtools formanagement oforthodontic models,systematicinspection, detailedanalysis, treatmentsimulation andvirtual appliancedesign options(Export of Models | The 3Shape OrthoSystem™ ...is intended for useas a medical front-end device providingtools formanagement oforthodontic models,systematicinspection, detailedanalysis, treatmentsimulation andvirtual appliancedesign options(Custom Metal | BRIUS PlannerSoftware...is intended for useas a medical front-end device providingtools formanagement oforthodontic models,systematicinspection,treatment simulationand virtual appliancedesign options(Patient-SpecificNitinol Wires | Similar |
| Specification | Proposed Device:Titan Dental Design | Primary PredicateDevice:3Shape OrthoSystem (K152086) | Predicate Device:BRIUS PlannerSoftware (K212828) | ComparisonResult |
| Indirect BondingTransfer Media,Sequential aligners)based on 3D modelsof the patient'sdentition before thestart of anorthodontictreatment. It canalso be appliedduring the treatmentto inspect andanalyze the progressof the treatment. Itcan be used at theend of the treatmentto evaluate if theoutcome isconsistent with theplanned/desiredtreatmentobjectives. | Bands, Export ofModels, IndirectBonding TransferMedia) based on 3Dmodels of thepatient's dentitionbefore the start ofan orthodontictreatment. It canalso be appliedduring thetreatment to inspectand analyze theprogress of thetreatment. It can beused at the end ofthe treatment toevaluate if theoutcome isconsistent with theplanned/desiredtreatmentobjectives. | Sequential Aligners,Export of Models,Indirect BondingTransfer Media)based on 3D modelsof the patient'sdentition before thestart of anorthodontictreatment. It can alsobe applied during thetreatment to inspectand analyze theprogress of thetreatment. It can beused at the end ofthe treatment toevaluate if theoutcome isconsistent with theplanned/desiredtreatment objectives. | ||
| The use of TitanDental Designrequires the user tohave the necessarytraining and domainknowledge in thepractice oforthodontics, as wellas to have received adedicated training inthe use of thesoftware. | The use of the OrthoSystem™ requiresthe user to have thenecessary trainingand domainknowledge in thepractice oforthodontics, as wellas to have received adedicated training inthe use of thesoftware. | The use of the BRIUSPlanner requires theuser to have thenecessary trainingand domainknowledge in thepractice oforthodontics, as wellas to have received adedicated training inthe use of thesoftware | ||
| Specification | Proposed Device:Titan Dental Design | Primary PredicateDevice:3Shape OrthoSystem (K152086) | Predicate Device:BRIUS PlannerSoftware (K212828) | ComparisonResult |
| TechnologicalFeatures | • Stand AloneSoftware• Imports DigitalDental Scans• Can be used todesign DentalAppliances• Useful forDiagnosis,treatmentplanning, andCAD design• Virtual Planningof toothmovement | • Stand AloneSoftware• Imports DigitalPatient Scans• Can be used todesign DentalCasts• Useful forDiagnosis,treatmentplanning, and CADdesign• Virtual Planning oftooth movement | • Stand AloneSoftware Module• Imports DigitalPatient Scans• Can be used todesign Dental Casts• Useful forDiagnosis, treatmentplanning, and CADdesign• Virtual Planning oftooth movement• Supports STL Files | Similar |
| MinimumHardware/SoftwareRequirements | • OS: Android:Firmware Version8.0 Oreo or higher,iOS: FirmwareVersion 10 orhigher, Windows,Mac• RAM: 4 GB RAM• Video Card: 1 GBGPU• Hard Drive Space:4 GB• CPU: 2.6 GHz• Web browser(Titan DentalDesign):Windows: .exe,Mac: .pkg,Android: .apk,IOS: .ipa• Internet Access | • OS: Windows 7, 8,64-bit• RAM: 8 GB• Video CardMemory: 1 GBGeForce• Hard Drive Space:250 GB• CPU: Intel Core i5or equivalent• Network InternetConnection• Mouse: withwheel button | • OS: Windows 1064-bit• RAM: 8 GB• MonitorResolution:1280 X800• Video CardMemory: 1 GB• Hard Drive Space:10 GB• CPU: Intelcompatible 2.6GHz/Dual or Quadcore 2.6 GHz• Mouse: Any Mousewith scrolling wheelor button | Similar |
| Login Method | Username andpassword | Username andpassword | Username andpassword | Same |
| SupportedAnatomic Areas | Maxilla/Mandible | Maxilla/Mandible | Maxilla/Mandible | Same |
| Intended Use | ||||
| Specification | Proposed Device:Titan Dental Design | Primary PredicateDevice:3Shape OrthoSystem (K152086) | Predicate Device:BRIUS PlannerSoftware (K212828) | ComparisonResult |
| Managing Patientand case base data | Yes | Yes | Yes | Same |
| Collection of studymaterial | Yes | Yes | Yes | Same |
| Alignment of studymaterial | Yes | Yes | Yes | Same |
| Measuring studymaterial | Yes | Yes | Yes | Same |
| Analyzing studymaterial | Yes | Yes | Yes | Same |
| Treatmentsimulation | Yes | Yes | Yes | Same |
| Virtual appliancedesign | Yes | Yes | Yes | Same |
| Surface scan forintraoral scanner | Yes | Yes | Yes | Same |
| Surface scan fromSTL file | Yes | Yes | Yes | Same |
| Arch shape | Yes | Yes | Yes | Same |
| Overbite/overjet | Yes | Yes | Yes | Same |
| Occlusal map | Yes | Yes | Yes | Same |
| 3D treatmentsimulation | Yes | Yes | Yes | Same |
| Orthodontic | Yes | Yes | Yes | Same |
| Appliance virtualpreparation | Yes | Yes | Yes | Same |
| Orthodonticappliance design | Yes | Yes | Yes | Same |
| Orthodonticappliance export | Yes | Yes | Yes | Same |
| Creating, editing,and copying patientdata | Yes | Yes | Yes | Same |
| Creating, editing,and copying case | Yes | Yes | Yes | Same |
| Specification | Proposed Device: Titan Dental Design | Primary Predicate Device:3Shape Ortho System (K152086) | Predicate Device:BRIUS Planner Software (K212828) | Comparison Result |
| data |
Table 5 Device Comparison Table
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Comparison of Indications for Use to the Predicate Devices:
Based on the above comparison, the indications of use of the Proposed Device is similar to that of the Predicate Devices. The alteration of indication for use statement to the Predicate Device (3Shape Ortho System, K152086) within this 510(k) submission of the Proposed Device 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 (Custom Metal Bands, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment". The proposed device, Titan Dental Design, manufactures sequential aligners, rather than Custom Metal Bands like those manufactured by the Predicate Device. However, the secondary Predicate Device's (Brius Planner Software, K212828), indication for use statement matches the indications for use statement of the Proposed Device in that it lists Sequential Aligners as one of its "virtual appliance design options",
Based on the similarity of indication for use, the Proposed Device can be considered substantially equivalent to the Predicate Devices.
Comparison of Technological Characteristics to Predicate Devices:
Based on the above comparisons, the design, construction, and performance characteristics of the Proposed Device are similar to that of the Predicate Devices. The differences identified are not substantial differences in operation of the device. Thus, the Proposed Device can be considered substantially equivalent to the Predicate Devices.
Summary of Performance Data and Substantial Equivalence
Utilizing FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2015) the Proposed Device, Titan Dental Design underwent appropriate integration, verification, and validation testing. The software passed the testing and performed per its intended use.
Conclusion:
Based on comparison of indications for use, technological features, performance testing, and software validation testing, the Proposed Device, Titan Dental Design, has been shown to be appropriate for its indications for use and is substantially equivalent to the legally marketed Predicate Devices, 3Shape Ortho System (K152086) and Brius Planning Software (K212828)
§ 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.