(300 days)
The SunClear Aligner system is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). SunClear Aligners positions teeth by way of continuous gentle force.
SunClear Aligners consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3-D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. SunClear Aligners are intended as an alternative to conventional bracket technology and fixed appliances for the treatment of patients with malocclusion.
The proprietary software generates the final image of a treated state and then interpolates a series of images that represent the intermediate teeth states. The dental practitioner then reviews these images to depict, edit, view, monitor, and approve an orthodontic treatment plan.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SunClear Aligner system:
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about a novel performance study with acceptance criteria. Therefore, much of the requested information regarding detailed study design, ground truth establishment, expert qualifications, and specific effect sizes for AI assistance or standalone performance is not present in the provided text.
The primary "study" described here is a bench test comparing flexural strength. The acceptance criteria are essentially met by demonstrating similarity to the predicate device and the use of previously cleared materials.
Description of Acceptance Criteria and the Study that Proves the Device Meets Acceptance Criteria
The SunClear Aligner system's acceptance criteria are centered on demonstrating substantial equivalence to existing legally marketed devices, specifically the K172765 - Smart Moves Complete aligner system and, for software technology, K150702 - eXceed Computerized Precision Bracket Placement Solution. The device's performance is primarily evaluated through a non-clinical bench test on flexural strength and by verifying the use of materials previously cleared for similar intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Indications for Use | Similar to predicate device (K172765). Indicated for the treatment of tooth malocclusion in patients with permanent dentition (all second molars) by positions teeth via continuous gentle force. The software utilized must be identical to that cleared under K150702 and K172765. | "The Indications for Use are similar to predicate - K172765 - Smart Moves Complete." The software is "identical to what was cleared under K150702 and K172765." |
| Technology and Construction | Similar to predicate device (K172765). Aligners manufactured the same as the predicate, including identical materials. | "The technology and construction are similar to predicate - K172765 - Smart Moves Complete." "The software is identical, and the aligners are manufactured the same as the predicate including the identical materials." |
| Environment of Use | Similar to predicate (K172765) and reference (K150702). Home use. | "The environments of use are similar to predicate - K172765 – Smart Moves Complete and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution." "The environment is similar to predicate and reference, namely - home use." |
| Patient Population | Similar to predicate (K172765) and reference (K150702). Patients needing treatment of tooth malocclusion. | "The patient population is similar to predicate K172765 – Smart Moves Complete and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution." "The patient population is similar to the predicate - K172765 - Smart Moves Complete." |
| Biocompatibility | Aligner material identical to K062828 - Dentsply International Aligner materials, which has similar intended use and patient contact, thus eliminating need for new testing. | "No testing was performed as the material of the aligners is identical to the K062828 - Dentsply International - Aligner materials which has similar intended use and patient contact." |
| Performance (Bench Testing) | Flexural Strength: Demonstrate comparable flexural strength to the predicate materials. The aligner material used must have been previously cleared under K062828 for the intended use. The objective is to show that the SunClear Aligners, made of similar material, perform comparably. No specific quantitative criteria are provided but the implication is "non-inferiority" or "comparability" to the predicate/cleared material. | "SunClear Aligners are made of similar aligner material as the predicate. The identified aligner material has been cleared under K06282 for the intended use. We have performed flexural strength of the subject device and predicate materials." (Conclusion: "The sponsor has demonstrated through performance testing... that the proposed device and predicate have been found to substantially equivalent.") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the flexural strength bench testing. The testing was performed on "the subject device and predicate materials," implying a sample of aligner materials.
- Data Provenance: The flexural strength testing would have been conducted in a lab environment. No information on country of origin for this specific test, nor if it was retrospective or prospective, is provided, as it is a bench test on materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this 510(k) summary. The primary evaluation involved material properties (flexural strength) and comparison to predicate device specifications, not expert-based ground truth for clinical outcomes or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. The flexural strength testing would involve objective measurements, not subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided document does not describe any MRMC comparative effectiveness study, nor does it mention AI assistance for human readers. This device is an orthodontic aligner system, not an AI-powered diagnostic or assistive tool in the context of human reading of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device includes proprietary 3-D software, the summary does not describe a standalone performance study of the software as a diagnostic or analytical algorithm without human-in-the-loop. The software's role is described as generating images for dental practitioners to review, edit, and approve, implying human supervision. The software itself is considered "identical" to a previously cleared system (K150702), indicating that its performance was likely evaluated as part of that prior submission.
7. The Type of Ground Truth Used
For biocompatibility, the ground truth is established by prior clearance of identical materials (K062828 - Dentsply International Aligner Material) for similar intended use and patient contact.
For flexural strength, the ground truth is established by objective measurements being comparable to the predicate device's materials.
There is no "expert consensus, pathology, or outcomes data" ground truth described in this 510(k) summary for the device's performance, as the emphasis is on material equivalence and functional similarity to predicates.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (aligner system with associated software), not a machine learning model developed with a dedicated training set. The software is stated to be "identical" to previously cleared software, implying its development and validation occurred prior to this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a dedicated training set for a novel machine learning algorithm in this 510(k) summary.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
December 16, 2019
Sun Dental Laboratories, LLC % Paul Dryden President Sun Dental Laboratories, LLC / ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K190394
Trade/Device Name: SunClear Aligner system Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 13, 2019 Received: November 14, 2019
Dear Paul Dryden:
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. 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) K190394
Device Name Sun Clear Aligner system
Indications for Use (Describe)
The SunClear Aligner system is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). SunClear Aligners positions teeth by way of continuous gentle force.
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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| Date Prepared: | 13-Dec-2019 |
|---|---|
| Sun Dental Laboratories, LLC1800 9th Ave NSt. Petersburg, FL 33713T - 727-561-9777 | |
| Official Contact: | Derek Diasti, President |
| Submission Correspondent: | ProMedic, LLCPaul Dryden, President131 Bay Point Dr. NESt. Petersburg, FL 33704E - paul.dryden@promedic.ccT – 239-307-6061 |
| Proprietary or Trade Name: | SunClear Aligner system |
| Common/Usual Name: | Sequential aligner and software |
| Classification Name: | 21CFR 872.5470NXC - Aligner, SequentialClass II |
| Predicate Device: | K172765 - Smart Moves Complete |
| Reference Device: | K150702 - eXceed Computerized Precision BracketPlacement Solution |
Device Description:
Orthodontic treatment is conventionally performed using brackets and arch wires. A bracket is bonded to each tooth and a wire is inserted with the goal of moving each tooth to a desired final treatment position. An alternative to traditional bracket treatment has been in existence for the past 20 years. This alternative treatment uses clear plastic aligners to gradually move the teeth. The aligners are designed in a series of incremental stages. A patient wears each aligner stage for a period of two weeks to accomplish the programmed tooth movement. Once tooth movement has been accomplished for a given stage the current aligner is removed and the next aligner in the sequence is worn. This method of orthodontic treatment is popular with patients because it provides a virtually invisible appliance and avoids the appearance of braces on the teeth.
Indications for use:
SunClear Aligner system is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). SunClear Aligner positions teeth by way of continuous gentle force.
Patient Population:
Patients needing treatment of tooth malocclusion
Environments of use: Home
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510(k) Summary
The following table presents the comparison to support substantial equivalence.
The table below compares the key features of the proposed SunClear Aligner system with the identified predicate – K172765 – Smart Moves Complete and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution and demonstrates that this proposed device can be found substantially equivalent.
Indications for Use - The Indications for Use are similar to predicate - K172765 - Smart Moves Complete. There is a difference between the proposed SunClear Aligner system and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution, however, the software utilized in this submission is identical to what was cleared under K150702 and K172765.
Discussion - The Indications for Use are similar to predicate - K172765 - Smart Moves Complete.
Technology and construction - The technology and construction are similar to predicate -K172765 - Smart Moves Complete. There is a difference between the proposed SunClear Aligner system and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution, in that K150702 is for brackets.
Discussion - The software is identical, and the aligners are manufactured the same as the predicate including the identical materials.
Environment of Use – The environments of use are similar to predicate - K172765 – Smart Moves Complete and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution.
Discussion - The environment is similar to predicate and reference, namely - home use.
Patient Population – The patient population is similar to predicate K172765 – Smart Moves Complete and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution Discussion - The patient population is similar to the predicate - K172765 - Smart Moves Complete.
Workflow - The patient actively interacts with the dentist / orthodontist. Interactions include the patient visits a dental office; Dentist/orthodontist completes a comprehensive exam, takes xrays and clears patient for orthodontic treatment; Dentist/orthodontist takes dental impressions or scans of patient and completes diagnostic records and sends to the lab who in turn fabricates models, thermoforms aligners, and sends aligners to the dentist to confirm patient fit.
Non-Clinical Testing Summary -
Biocompatibility - No testing was performed as the material of the aligners is identical to the K062828 - Dentsply International - Aligner materials which has similar intended use and patient contact.
Bench testing - SunClear Aligners are made of similar aligner material as the predicate. The identified aligner material has been cleared under K06282 for the intended use. We have performed flexural strength of the subject device and predicate materials.
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.
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510(k) Summary
| Device Comparison | SunClear Aligner system | Predicate | Reference |
|---|---|---|---|
| K172765 – Smart Moves Complete | K150702 - eXceed ComputerizedPrecision Bracket Placement Solution | ||
| Model | SunClear Aligner system | Smart Moves Complete | eXceed Software |
| Indications for Use | SunClear Aligner system is indicated forthe treatment of tooth malocclusion inpatients with permanent dentition (i.e. allsecond molars). SunClear Alignerspositions teeth by way of continuousgentle force. | Smart Moves Complete is indicated forthe treatment of tooth malocclusion inpatients with permanent dentition (i.e. allsecond molars). Smart Moves Completepositions teeth by way of continuousgentle force. | eXceed Computerized Precision BracketPlacement Solution is a software systemintended for use as an aid in orthodontictreatment planning to correctMalocclusions in Orthodontic Patients.For use by dental professionals trained inorthodontic treatment, includingradiographic analyses and treatmentplanning. eXceed ComputerizedPrecision Bracket Placement Solution isintended for use with commerciallyavailable brackets currently used instandard orthodontic treatment. The endproduct is an indirect bonding tray foruse by the Dental professional to placemultiple brackets at the same time. |
| Target Population | Patients needing treatment of toothmalocclusion | Patients needing treatment of toothmalocclusion | Patients needing treatment of toothmalocclusion |
| Environment of Use | Home | Home | Home |
| OTC or Rx | Rx | Rx | Rx |
| Design | Single Patient, multi-use | Single Patient, multi-use | Single Patient, multi-use |
| Device Comparison | SunClear Aligner system | PredicateK172765 - Smart Moves Complete | ReferenceK150702 - eXceed ComputerizedPrecision Bracket Placement Solution |
| Device Description | SunClear Aligners consists of a series ofdoctor-prescribed, thin, clear plasticremovable orthodontic appliances (aligners)and proprietary 3-D software. The alignersgently move the patient's teeth in smallincrements from their original state to amore optimal, treated state. SunClearAligners are intended as an alternative toconventional bracket technology and fixedappliances for the treatment of patients withmalocclusion.The proprietary software generates the finalimage of a treated state and then interpolatesa series of images that represent theintermediate teeth states. The dentalpractitioner then reviews these images todepict, edit, view, monitor, and approve anorthodontic treatment plan. | Smart Moves Complete consists of aseries of doctor-prescribed, thin, clearplastic removable orthodonticappliances (aligners) and proprietary3-D software. The aligners gentlymove the patient's teeth in smallincrements from their original state toa more optimal, treated state. SmartMoves Complete is intended as analternative to conventional brackettechnology and fixed appliances forthe treatment of patients withmalocclusion.The proprietary software generates thefinal image of a treated state and theninterpolates a series of images thatrepresent the intermediate teeth states.The dental practitioner then reviewsthese images to depict, edit, view,monitor, and approve an orthodontictreatment plan. | Using the images provided by the DentalProfessional, the software creates a 3Dmodel and identifies the ideal placementof the brackets. The file is sent to theDental Professional for review andapproval. The Dental Professional mayadjust the final position of the bracket ifdesired. A 3D model is printed, and thebrackets are placed on the model in theprescribed location, approved by theOrthodontist. An indirect bonding tray isfabricated with the bracketsin place. The tray and brackets are sentto the Dental professional. The DentalProfessional places the indirect trayusing their chosen commerciallyavailable bracket adhesive |
| Technology | eXceed Software | eXceed Software(referred to as SmartMoves) | eXceed Software |
| Using the images provided by the DentalProfessional, the software creates a 3Dmodel and identifies the ideal placement ofthe aligners. | Using the images provided by the DentalProfessional, the software creates a 3Dmodel and identifies the ideal placementof the aligners. | Using the images provided by the DentalProfessional, the software creates a 3Dmodel and identifies the ideal placementof the brackets. | |
| Workflow | - Patient visits a dental office- Dentist/orthodontist completes acomprehensive exam, takes x-rays and clearspatient for orthodontic treatment- Dentist/orthodontist takes dental impressionsor scans of patient and completes diagnosticrecords and sends to the lab. - Lab fabricatesmodels, thermoforms aligners, and sends backto dentist to confirm patient fit. | Not known | Active patient clinician interactionthroughout the treatment period |
| Device Comparison | SunClear Aligner system | PredicateK172765 – Smart Moves Complete | ReferenceK150702 - eXceed ComputerizedPrecision Bracket Placement Solution |
| Mode of Action | Orthodontic tooth movement occursthrough forces applied by the applianceto the dentition as each tooth follows theprogrammed displacement based on adoctor's prescription. | Orthodontic tooth movement occursthrough forces applied by the applianceto the dentition as each tooth follows theprogrammed displacement based on adoctor's prescription. | N/A |
| Method of Use | Each preformed plastic tray isworn by the patient as prescribed by thedental practitioner, usually a fewweeks prior to using the nextsequential aligner tray | Each preformed plastic tray isworn by the patient as prescribed by thedental practitioner, usually a fewweeks prior to using the nextsequential aligner tray | N/A |
| Biocompatibility /Materials | K062828Dentsply International Aligner Material | Great Lakes Splint Biocryl | N/A |
| Performance testing | Strength testing | Strength testing | N/A |
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510(k) Summary
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§ 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.