(21 days)
The Illusion Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.
Illusion Aligners are intraoral thermoformed plastic aligners that are worn at least 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning. Illusion Aligners are fabricated using a ten-step process.
The Step 1 is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. Step 3, the scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. In the Step 3, Laxmi Dental Exports Pvt Ltd, Inc. utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. Step 4, the treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. Step 5 is the printing of 3D models of the treatment plan for use in Step 7 thermoforming. The thermoforming process is accomplished using a standard thermoforming equipment and the appropriate material as outlined in this submission.
The provided document, K211010, describes a 510(k) premarket notification for "Illusion Aligners." This document primarily focuses on establishing substantial equivalence to a predicate device (Smylio Invisible Clear Aligner, K173784) rather than presenting a detailed study proving the device meets specific performance acceptance criteria in the manner of a clinical trial for a novel AI/software medical device.
Therefore, the information required for a comprehensive answer regarding acceptance criteria and a study proving device performance (especially for an AI/ML device) is largely not present in this document.
However, I can extract the information that is available and explain why other requested information is missing.
1. A table of acceptance criteria and the reported device performance
This document does not present quantitative acceptance criteria or reported device performance for a software-driven clinical outcome in the format typically seen for AI/ML devices. Instead, it focuses on demonstrating equivalence through material properties and manufacturing processes.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Justification of Equivalence (Illusion Aligners) |
|---|---|---|
| Biocompatibility | Adherence to ISO 10993 standards: - Part 5 (Cytotoxicity Elution - MEM) - Part 10 (Skin Irritation) - Part 10 (Guinea Pig Maximization Test) | - PETG (Polyethylene terephthalate glycol) material tested according to Good Laboratory Practices. - Tests performed as per ISO 10993 Parts 5 and 10. - "No effect on biocompatibility. ISO 7405 directly references the same test as conducted using ISO 10993 et.al." (referring to the predicate device's biocompatibility summary). |
| Non-Clinical Physical Properties | Adherence to ASTM standards: - Elongation @ Yield (%) ASTM D638 - Elongation @ Break (%) ASTM D638 - Tensile @ Yield (PSI) ASTM D638 - Tensile Strength (PSI) ASTM D638 - Tensile Modulus (PSI) ASTM D638 - Water Absorption (%) 24 hours @ 23°C ASTM D570 | - Device material tested to the listed ASTM standards. - Stated that the material "meet the acceptance criteria" (specific values not provided in this summary). |
| Intended Use | "Alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion." | The "Illusion Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion." This matches the predicate device's intended use. |
| Technological Principle (Mode of Action) | "Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays." | "In the same manner as the predicate device, each aligner exerts gentle force to achieve progressive realignment of the teeth until the final correction has been attained. This is based on the treatment plan and proceeds over time." |
| Manufacturing Process / Software | Use of FDA 510(k) cleared software for treatment planning. | Utilizes "3Shape Software K180491 and K152086," which are "FDA 510K cleared." "The use/manufacturing process has been validated by Laxmi." "Laxmi Dental Exports Pvt Ltd. prepares the treatment plan in Step 2... for subsequent approval by a doctor," which is considered "No effect, both treatment plans are doctor approved" when compared to the predicate. |
| Material (Equivalence to Predicate) | Material properties suitable for clear aligners, showing no safety or effectiveness differences when compared to the predicate. | Illusion Aligners use PETG (Polyethylene terephthalate glycol) material versus the predicate's "Thin thermoformed polyurethane" (Smylio Uses Zendura polyurethane). "No effect, PETG (Polyethylene terephthalate glycol) material is manufacturing validated and biocompatible." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes non-clinical physical and biocompatibility testing of the material itself, not a clinical study on patient outcomes with a "test set" of patient data. The "testing" referred to is laboratory testing of the material. There is no mention of a test set for assessing algorithmic performance on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. There is no "test set" with ground truth established by experts described in this 510(k) summary relating to clinical performance or AI/ML algorithm output. The document focuses on material properties and manufacturing process equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. No adjudication method for a test set is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. This device is a physical orthodontic aligner. While its manufacturing process involves software for treatment planning, the document does not describe it as an AI-assisted diagnostic or decision-support tool that would undergo an MRMC study comparing human performance with and without AI assistance. The software mentioned (3Shape) is for designing the aligners, not for interpreting medical images or providing clinical diagnoses.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is not an algorithm-only standalone diagnostic or treatment device. It is a physical aligner whose design process uses software. The software, 3Shape, is referred to as "FDA 510K cleared," indicating it has its own clearance. The current submission is for the physical aligners.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided in the context of an AI/ML device performance study. The "ground truth" here would relate to the physical and biocompatibility properties of the material, which are measured directly by laboratory tests (e.g., precise measurements for ASTM standards, cellular responses for ISO 10993).
8. The sample size for the training set
This information is not applicable/not provided. Since this is a submission for a physical medical device (aligners) and not a de novo AI/ML algorithm, there is no mention of a "training set" in the context of machine learning. The "training" here would refer to the historical data and experience used to develop the manufacturing process and material selection.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as #8.
{0}------------------------------------------------
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 & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
April 26, 2021
Laxmi Dental Exports Pvt Ltd % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, Florida 33155
Re: K211010
Trade/Device Name: Illusion Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: April 3, 2021 Received: April 5, 2021
Dear Rafael Aguila:
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
{1}------------------------------------------------
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,
Michael E. Adjodha, M.ChE. 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K211010
Device Name Illusion Aligners
Indications for Use (Describe)
The Illusion Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K211010
510(k) Summary
| Submitter Name: | Laxmi Dental Exports Pvt Ltd. |
|---|---|
| Submitter Address: | Survey No. 201/1, Village Gundale, Boisar Chillar Highway, Boisar, District - Palghar,India - 401501 |
| Phone Number: | 0091 9820268438 |
| Contact Person: | Sameerl Merchant |
| Date Prepared: | November 04,2020 |
| Device Trade Name: | Illusion Aligners |
| Common Name | Aligner, Sequential |
| Classification NameNumberProduct CodeRegulatory Class | Orthodontic Plastic Bracket21 CFR 872.5470NXC2 |
| Primary PredicateDevice: | K173784, Smylio Invisible Clear Aligner |
| Statement ofIndicationsfor Use | The Illusion Aligners indicated for use in the alignment of permanentteeth (i.e. all second molars) through orthodontic treatment ofmisalignment and malocclusion. |
| Device Descriptionand Summary ofTechnologicalCharacteristics | Illusion Aligners are intraoral thermoformed plastic aligners that areworn at least 22 hours per day and are designed to be used in asequence, each aligner providing a gentle continuous force, toallow for the movement of teeth to the final desired position. Thealigners are to be removed for eating and for cleaning. IllusionAligners are fabricated using a ten-step process.The Step 1 is to obtain the dimensions and details of the patient'sbaseline dentition. This is generally done using an oral scan data ora physical impression. Step 3, the scanned data (digital CAD/CAMmodels or patient models) are imported into specialized dentalsoftware for treatment planning. In the Step 3, Laxmi DentalExports Pvt Ltd, Inc. utilizes a software application to plan thetreatment by creating a series of sequential models that graduallyposition the teeth into their final desired position. Step 4, thetreatment plan is sent to the doctor for approval. Upon approval, a3D printer is used to create the molds needed for each treatmentstep to provide the surface around which the aligner isthermoformed. Step 5 is the printing of 3D models of the treatmentplan for use in Step 7 thermoforming. The thermoforming processis accomplished using a standard thermoforming equipment andthe appropriate material as outlined in this submission. |
| Mechanism of Action | In the same manner as the predicate device, each alignerexerts gentle force to achieve progressive realignment of theteeth until the final correction has been attained. This is basedon the treatment plan and proceeds over time. |
| Device Testing | BiocompatibilityContact of the device to the patient's oral tissue requires theAligners material to be biocompatible. The thermoplastic PETG(Polyethylene terephthalate glycol) material has been testedaccording to Good Laboratory Practices for its biocompatibilityaccording to ISO 10993, as follows:Part 5 (Cytotoxicity Elution - MEM)Part 10 (Skin Irritation)Part 10 (Guinea Pig Maximization Test) |
| Animal Human TestingNo human testing is required for this product because it iscomposed of the same materials and has a similar design andmethod of manufacture/fabrication in comparison to thepredicate device. | |
| Non-Clinical PhysicalProperties Testing: | Device material tested to the following standards and meet the acceptancecriteria• Elongation @ Yield (%) ASTM D638• Elongation @ Break (%) ASTM D638• Tensile @ Yield (PSI) ASTM D638• Tensile Strength (PSI) ASTM D638• Tensile Modulus (PSI) ASTM D638• Water Absorption (%)24 hours @ 23°C ASTM D570 |
{4}------------------------------------------------
{5}------------------------------------------------
| Trade Name: | Submission Device | Predicate Device |
|---|---|---|
| Illusion Aligners | K173784Smylio Invisible Clear AlignersK173785 | |
| 510(k) Number | ||
| Manufacturer | Laxmi Dental Exports Pvt Ltd | Smylio |
| Classification #, | 21 CFR 852.5470 | 21 CFR 852.5470 |
| Product Code | NXC | NXC |
| Device Class | 2 | 2 |
| Intended Use | The Illusion Aligners indicated for use in thealignment of permanent teeth (i.e. all secondmolars) through orthodontic treatment ofmisalignment and malocclusion. | Smylio Invisible Clear Aligners is indicatedfor use in the alignment of permanentteeth through orthodontic treatment ofmisalignment and malocclusion. |
| Mode of Action | Alignment of teeth by application ofcontinuous gentle force, by sequential useof preformed plastic trays. | Alignment of teeth by application ofcontinuous gentle force, by sequential useof preformed plastic trays. |
| Method of Use | Each preformed plastic tray is worn bythe patient as prescribed by the dentalpractitioner, usually a few weeks prior tousing the next sequential Aligners tray. | Each preformed plastic tray is wornby the patient as prescribed by thedental practitioner, usually a fewweeks prior to using the nextsequential Aligners tray. |
| Material | PETG (Polyethyleneterephthalate glycol) Material | Thin thermoformedpolyurethane |
| Biocompatible | Yes | Yes |
| OTC or Rx | Rx | Rx |
| Software Use | Yes | Yes |
| Sterile | No | No |
Differences between Illusion Aligners compared to predicate device
| Illusion Aligners | S & E Effect | Smylio K173784 |
|---|---|---|
| Laxmi Dental Exports Pvt Ltd. preparesthe treatment plan in Step 2 of themanufacturing process for subsequentapproval by a doctor. | No effect, both treatmentplans are doctor approved. | Smylio K173784 doctorprepares the treatmentplan |
| Laxmi Dental Exports Pvt Ltd, Inc. uses3Shape Software K180491 andK152086 | No effect, 3Shape SoftwareK180491 and K152086 areFDA 510K cleared, theuse/manufacturing processhas been validated byLaxmi | Smylio uses 3ShapeSoftware K152086 |
| Laxmi uses PETG (Polyethyleneterephthalate glycol) thermoformingmaterial for the aligner | No effect, PETG(Polyethyleneterephthalate glycol)material is manufacturingvalidated andbiocompatible. | Smylio Uses Zendurapolyurethane |
{6}------------------------------------------------
| Laxmi Dental Exports Pvt Ltd, Inc. | No effect on | Smylio biocompatibility |
|---|---|---|
| biocompatibility summary applied ISO10993 | biocompatibility. ISO 7405directly references the | summary references ISO7405, Dentistry – |
| • -5, Biological evaluation of medicaldevices – Part 5: Tests for in vitrocytotoxicity• -10, Biological evaluation of medicaldevices -- Part 10: Tests for irritationand skin sensitization | same test as conductedusing ISO 10993 et.al. | Evaluation ofbiocompatibility ofmedical devices used indentistry |
The intended use of the Illusion Aligners is the same to that of the primary predicate device as they are both intended for correcting dental malocclusion in patients with permanent dentition. It has a similar technological principle, and the device characteristics are similar to the predicate device. The mode of operation and the manufacturing process used to fabricate the aligner trays is the same as the predicate device. There are minor differences comparing Illusion Aligners to the predicate Smylio Invisible Clear Aligners which do not affect substantial equivalence or safety and effectiveness.
Substantial Equivalence Conclusion
Thus, based on the above it can be concluded that Illusion Aligners is substantially equivalent to the predicate device.
§ 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.