The Invisalign® System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and permanent dentition. The optional mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition.

Device Description

The subject device, Invisalign System, is a modification to the predicate device, Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (K232233, cleared on September 26, 2023) to introduce an additional treatment planning workflow that does not require any Align Computer Aided Design (CAD) technician interaction. The Invisalign System consists of removable orthodontic appliances (aligners) and proprietary 3D treatment planning software. As part of this submission, there are no proposed design changes made to standard aligners or aligners with Mandibular Advancement Features (MAF) since the clearance of K232233. Further, there are no proposed changes to the proprietary 3D treatment planning software except for the non-significant changes that were implemented via Letter to File.

Like the predicate device, the Invisalign System consists of a series of doctor prescribed, customized, thin, clear plastic aligners that gently move the patient's teeth in small increments from their original state to a more optimal, treated state to address malocclusion. The optional MAF positions patients jaw forward to address skeletal malocclusion. The system is used in patients with primary, mixed, and permanent dentition.

The proposed modification in this premarket notification is to add a completely automated endto-end treatment planning workflow without CAD technician involvement. The subject device, Invisalign System, is the Invisalign System aligners produced with the additional treatment planning workflow.

There are no proposed design changes to the Invisalign System components as part of this submission.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for the Align Technology Invisalign System. It focuses on demonstrating substantial equivalence to a predicate device (K232233) for an updated version of the Invisalign System that includes an additional, fully automated treatment planning workflow.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

The document explicitly states that the submission is for a Special 510(k) notice to introduce an additional treatment planning workflow that does not require Align CAD technician interaction. It emphasizes that no proposed design changes were made to the standard aligners, aligners with Mandibular Advancement Features, or the proprietary 3D treatment planning software, except for non-significant changes previously implemented via Letter to File.

The core of the acceptance criteria and supporting study revolves around demonstrating that this new automated workflow achieves the same treatment plan and aligner output as existing workflows, and that this change does not affect the safety and effectiveness of the Invisalign System, nor does it raise any new questions of safety and effectiveness.

1. Table of acceptance criteria and the reported device performance:

Since this is a Special 510(k) for a workflow change, the acceptance criteria are not presented as numerical performance metrics in a typical table format for accuracy or sensitivity. Instead, they are framed as qualitative equivalency and safety/effectiveness assurances.

Acceptance Criteria (Implicit)	Reported Device Performance
Equivalence of Treatment Plan Output: The additional automated workflow must produce treatment plans and aligner output equivalent to that of existing, cleared workflows (completely manual and combined manual/automated).	V&V testing demonstrated the additional workflow achieved "the same treatment plan and aligners output as existing workflows."
No Adverse Impact on Safety and Effectiveness: The introduction of the new workflow must not negatively affect the safety and effectiveness of the Invisalign System.	V&V testing demonstrated the additional workflow "does not affect the safety and effectiveness of the Invisalign System," and "does not affect the substantial equivalence of the Invisalign System." The document repeatedly states, "All testing passed acceptance criteria and demonstrated the device modification does not affect the safety and effectiveness of Invisalign System, and do not raise any new questions of safety and effectiveness."
No New Questions of Safety and Effectiveness: The change should not introduce unforeseen risks or concerns.	V&V testing demonstrated the device modification did "not raise any new questions of safety and effectiveness."
Compliance with Predicate Device Characteristics: Maintain same intended use, principles of operation, technological characteristics, and device design (product specification, material, performance).	The document explicitly states: "The Invisalign System (subject device) ... and the predicate device have the following similarities: Same Intended Use/Indications for Use, Same principles of operation, Same technological characteristics, Same device design, such as product specification, material, and product performance."

2. Sample sized used for the test set and the data provenance:

The document does not provide specific sample sizes for the test set used in the verification and validation (V&V) activities. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This is typical for a Special 510(k) focused on a software workflow change for an established device, where the primary demonstration is of functional equivalence rather than clinical performance on patient cohorts.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number or qualifications of experts used to establish "ground truth" for the V&V of the automated workflow. Given the context, the "ground truth" for the automated workflow's output largely relates to its ability to replicate or achieve the same outcomes as an existing, human-in-the-loop workflow, which is already established by the predicate device's clearance. It's likely that internal engineers and potentially dental professionals (though not explicitly stated as "experts" for ground truth establishment in the V&V) were involved in comparing outputs.

4. Adjudication method for the test set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. This is consistent with a V&V study focused on functional equivalence of an automated workflow rather than a diagnostic performance study requiring expert consensus on subjective interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. The nature of this submission (a Special 510(k) for an automated workflow addition to an existing device) does not typically require MRMC studies. The focus is on the functional equivalence of the new automated process to the existing, human-assisted process, not on improving human reader performance with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, in the context of this submission, the "additional treatment planning workflow" is described as "completely automated end-to-end treatment planning workflow without CAD technician involvement." This implies a standalone (algorithm-only) performance was evaluated in terms of its ability to generate acceptable treatment plans and aligner outputs, which is then compared for equivalence to the human-in-the-loop processes. The V&V testing would have assessed this algorithm-only output against the established standards of the system.

7. The type of ground truth used:

The "ground truth" here is implied to be the established and accepted output of the predicate device's existing (manual or combined manual/automated) treatment planning workflows. The V&V compared the output of the new automated workflow to these established outputs, ensuring they were "the same treatment plan and aligners output." This is essentially a functional equivalence ground truth. It is not based on pathology, clinical outcomes data, or necessarily a new expert consensus on a novel diagnostic task, but rather on the consistency and correctness of the automated design process relative to the already-cleared, human-assisted process.

8. The sample size for the training set:

The document does not specify the sample size for the training set for the underlying proprietary 3D treatment planning software. This information is typically not provided in a 510(k) for a workflow modification if the core software algorithms (that would require training data) are not being substantially changed. The mention of an "automated end-to-end treatment planning workflow" suggests an AI/ML component, but details on its training are absent from this summary.

9. How the ground truth for the training set was established:

Since details on the training set are not provided, information on how its ground truth was established is also not available in this document.

Summary

{0}------------------------------------------------

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.

June 18, 2024

Align Technology, Inc. Nestor Vazquez Salgado Sr. Regulatory Affairs Specialist I 2820 Orchard Parkway San Jose, California 95134

Re: K241412

Trade/Device Name: Invisalign System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC. PNN Dated: May 17, 2024 Received: May 17, 2024

Dear Nestor Vazquez Salgado:

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.

{1}------------------------------------------------

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).

{2}------------------------------------------------

Sincerely,

Michael E. 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

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K241412

Device Name

Invisalign System

Indications for Use (Describe)

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)

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."

{4}------------------------------------------------

K241412 - 510(k) Summary

Align Technology's Invisalign System

General Information

510(k) Sponsor	Align Technology, Inc.
Address	2820 Orchard ParkwaySan Jose, CA 95134
FDA Registration Number	2953749
Contact Person	Nestor Vazquez SalgadoSr. Regulatory Affairs SpecialistAlign Technology, Inc.cc: Niya SuSr. Manager, Regulatory AffairsAlign Technology Inc.
Contact Information	Email: nevazquez@aligntech.comPhone: +1 408-470-1000Cell Phone: +1 412-298-4604Fax: +1408-470-1010
Date Prepared	June 13, 2024

Name of Modified Device and Name/Address of Sponsor

Name of Device	Invisalign System
Name/Address of Sponsor	Align Technology, Inc.2820 Orchard ParkwaySan Jose, CA 95134
Trade/Proprietary Name	Invisalign System
Common Name	Aligner, Sequential
Classification Name	Orthodontic Plastic Bracket
Regulation Number	21 CFR 872.5470
Product Code	NXC - AlignersPNN – Proprietary 3D Treatment Planning Software
Regulatory Class	II

{5}------------------------------------------------

Name of Device	Invisalign System with Mandibular Advancement Featuring OcclusalBlocks
Name/Address of Sponsor	Align Technology, Inc.
	2820 Orchard Parkway
	San Jose, CA 95134
Trade/Proprietary Name	Invisalign System
Common Name	Aligner, Sequential
Classification Name	Orthodontic Plastic Bracket
Regulation Number	21 CFR 872.5470
Product Code	NXC
Regulatory Class	II
510(k) number	K232233

Predicate Device

Purpose of the Special 510(K) Notice

The purpose of this Special 510(k) notice is to request clearance for an additional treatment planning workflow. Additionally, this pre-market notification adds PNN as the appropriate product code for the Invisalign System proprietary 3D treatment planning software and summarizes the non-significant changes that were implemented via Letter to File.

Intended Use

The Invisalign System (subject device) has the same intended use as the cleared predicate device (K232233), which is as follows:

"The Invisalian® System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and permanent), or permanent dentition. The optional mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition."

Device Description

{6}------------------------------------------------

aligners or aligners with Mandibular Advancement Features (MAF) since the clearance of K232233. Further, there are no proposed changes to the proprietary 3D treatment planning software except for the non-significant changes that were implemented via Letter to File.

There are no proposed design changes to the Invisalign System components as part of this submission.

Comparison with Predicate Device

In accordance with 21 CFR 807.92(a)(6) a summary of the technological characteristics' comparison of the proposed modified device to the predicate Device is provided below.

Technological Characteristics Comparison with the Predicate Device

Compared to the predicate device, the modified device does not change the Invisalign System's technological characteristics. All testing passed acceptance criteria and demonstrated the device modification do not affect the safety and effectiveness of Invisalign System, and do not raise any new questions of safety and effectiveness. A high-level device comparison is provided below in Table 1.

	Invisalign SystemSubject Device	Invisalign System withMandibular AdvancementFeaturing OcclusalBlocks (K232233) –Primary Predicate Device	SubstantialEquivalence
Indications for Use, User Population
Intended Use/Indication forUse	The Invisalign System isintended for the orthodontictreatment of malocclusionin patients with primary,mixed (primary andpermanent), or permanentdentition. The optional	The Invisalign System isintended for the orthodontictreatment of malocclusionin patients with primary,mixed (primary andpermanent), or permanentdentition. The optional	Same as predicatedevice.
	mandibular advancementfeature(s) are indicated forthe treatment of skeletalmalocclusion in patientswith mixed or permanentdentition.
PatientPopulation	Children, Adolescents_andAdults	Children, Adolescents, andAdults	Same as predicatedevice.
Use Location	Dental intraoral Devices	Dental intraoral Devices	Same as predicatedevice.
OTC orPrescription(Rx) Device	Rx only	Rx only	Same as predicatedevice.
Technological Characteristics
Principle ofOperation	Aligners: Sequentialaligners apply continuousgentle force to the teeth andposition mandible forward.Proprietary 3D TreatmentPlanning Software:Produces 3D-model file ofthe PVS impression or thedigital scan. Identifies allindividual teeth that requiretreatment (i.e.,repositioning). Creates atreatment plan (i.e., 3-Dmodels that represent thetreatment plan) which isreviewed by the treatingdental practitioner usingClinCheck's doctor facingfunction to reject or requestmodifications to the set-upprior to approval.Delivery Mechanism ofAttachment:1. Attachment Template -attachments are formedby dental practitioner whofills and packs wells in theTemplate tray withcommercially availabledental composite. The	Aligners: Sequentialaligners apply continuousgentle force to the teethand/or position mandibleforward.Proprietary 3D TreatmentPlanning Software:Produces 3D-model file ofthe PVS impression or thedigital scan. Identifies allindividual teeth thatrequire treatment (i.e.,repositioning). Creates atreatment plan (i.e., 3-Dmodels that represent thetreatment plan) which isreviewed by the treatingdental practitioner usingClinCheck's doctor facingfunction to reject orrequest modifications tothe set-up prior toapproval.Delivery Mechanism ofAttachment:Attachment Template -attachments are formed bydental practitioner who fillsand packs wells in the	Same as predicatedeviceSubject device isinclusive of anadditional optionalattachment deliverymechanism, InvisalignPre-FormedAttachment System,which has beencleared in 510(k)K222894.
	final shape &configuration is curedwhen template is seatedon dentition; or,2. Invisalign Pre-formedAttachment System - anoptional alternativeattachment deliverymechanism. It enablescorrect placement ofattachments and bondattachments to the toothsurface. The attachmentshape and configurationdefined by the InvisalignSystem treatment plan,manufactured togetherwith positioner. Theattachment shapes arecured to the tooth whenthe positioner is seatedon dentition.	Template tray withcommercially availabledental composite. The finalshape & configuration iscured when template isseated on dentition.
Materials	Thermoplastic polymer	Thermoplastic polymer	Same as predicatedevice.
	Treatment Planning Workflows
End-to-endTreatmentPlanningWorkflow	Includes the followingworkflows:● Completely Manual● Combination ofManual andAutomated● Fully AutomatedWorkflow	Includes the followingworkflows:● Completely Manual● Combination ofManual andAutomated	Similar to predicatedevice.The subject deviceintroduces an additionalautomated end-to-endtreatment planningworkflow. All existingworkflows remainunchanged. Verificationand validation (V&V)testing demonstratedthe additional workflowachieved the sametreatment plan andaligners output asexisting workflows;therefore, the changedoes not affect thesafety and

Table 1: Device Comparison Table

{7}------------------------------------------------

Align™ Invisalign System US FDA Special 510(k) — 510(k) Summary

{8}------------------------------------------------

{9}------------------------------------------------

	effectiveness of the
	Invisalign System.

Performance Data

There are no proposed design changes in the scope of this pre-market notification regarding existing Invisalign System's components (that is aligners and proprietary 3D treatment planning software) or accessories. Verification and validation testing activities were performed to evaluate the modified device. All testing passed acceptance criteria and demonstrated the device modification does not affect the substantial equivalence of the Invisalign System.

Biocompatibility

There are no proposed device design nor packaging changes as part of this submission: therefore, no biocompatibility information is needed.

Software Testing

There are no proposed changes to the Invisalign System proprietary 3D treatment planning software as part of this pre-market notification; however, the software changes required verification and validation (V&V) testing at the unit, integration, and system level. Verification and validation testing activities were performed to evaluate the modified device. All testing passed acceptance criteria and demonstrated the device modification does not affect substantial equivalence of the Invisalign System.

Substantial Equivalence

The Invisalign System (subject device) is a modification to the predicate device, Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (K232233), which was cleared on September 26, 2023. The subject device and the predicate device have the following similarities:

Same Intended Use/Indications for Use ●
Same principles of operation
. Same technological characteristics
. Same device design, such as product specification, material, and product performance

The subject device and predicate device have the following differences:

Subject device has an additional completely automated treatment planning workflow . without Align CAD technician involvement.
Verification and validation testing activities were performed to evaluate the modified device. All testing passed acceptance criteria and demonstrated the device modification does not affect the Substantial equivalence of the Invisalign System.

{10}------------------------------------------------

Conclusion

The subject/modified device has the same intended use and indications for use, principles of operation, technological characteristics, and device design as the predicate device. The subject device has an additional completely automated treatment planning workflow that is not available in the predicate device. Verification and validation testing demonstrated the differences do not affect the substantial equivalence of the Invisalign System.

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.