The Invisalign Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and tooth, palate) with primary, mixed, or permanent dention during orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.

Device Description

The subject device, Invisalign Palatal Expander (IPE) System (hereafter referred to as the IPE System) is a modification to the legally marketed multiple predicate devices. Invisalign System (Class II; Product Code: NXC; K220287) as Primary and Dentaurum Expansion Screws/Hyrax Expander – Hyrax ® and Hyrax neo® (Class I, Product Code: DYJ, K935154) as Secondary.

The IPE System consists of the Invisalign Palatal Expanders, Invisalign Palatal Holders, the Attachment Template and the proprietary 3D Shape generation software.

Invisalign Palatal Expanders are a staged series of removable orthodontic devices designed to expand the patient's skeletal and/or dental narrow maxilla (upper jaw, dental arch, teeth and palate) in small increments to an optimal position determined by the doctor. Once the desired clinical outcome of the expansion phase has been achieved, patients progress to the holding phase.

The Invisalign Palatal Holder is a copy of the last stage of the expansion phase designed to hold the maxilla post active expansion, to allow the maxilla to stabilize before the patient progresses to the next phase of treatment (retention, phase 2 or other treatment).

The proprietary Align internal personnel-facing 3D software enables Align's computer-aided design (CAD) designers to generate the shape and quantity/stages of the device. Using this software, CAD designers create digital files for the incremental stages of the doctorprescribed expansion amount and the design and quantity of holders per the prescribed holding duration. Each device in the series is fabricated via additive manufacturing (3D printing).

The Attachment Template (also a component of the primary predicate device, the Invisalign System) enables correct placement and bonding of attachments made of dental composite (material provided by doctor) to the tooth surface for IPE engagement and retention.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Invisalign Palatal Expander System. It outlines the device's indications for use, comparison to predicate devices, and performance data. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and a study proving the device meets those criteria for an AI/software component, particularly around metrics like sensitivity, specificity, or reader performance with and without AI.

The document mentions "proprietary 3D Shape generation software" and "includes software algorithms that are used to determine the shape and calculate the quantity of devices required." It also states "successful software verification and validation (V&V) testing at the unit, integration, and system level was performed to qualify the orthodontic software component of the subject device." This suggests that the software is a design and manufacturing tool, generating device shapes based on clinician prescriptions and patient scans, rather than an AI performing diagnostic or assistive tasks that would typically require the comparative performance studies you're asking about (e.g., MRMC studies, standalone performance with ground truth labels).

Therefore, based on the provided text, I can only provide information related to the device's overall performance and safety testing, not specific AI acceptance criteria and studies as if it were a diagnostic AI.

Here's what can be extracted and inferred from the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a table of quantitative acceptance criteria (e.g., specific thresholds for force, retention, etc.) for the various tests. Instead, it states that the test results "met the acceptance criteria and performed as intended" or were "found to be adequately designed."

Test Category	Reported Device Performance
Durability	All IPE devices maintained engagement on attachments, without deformation, cracks, chips, or breaks.
Stiffness/Force System	The device is structurally stiff and can deliver the required force in the lateral direction on the posterior teeth. Test results met acceptance criteria and performed as intended. (Note: The secondary predicate device, Hyrax, was used for acceptance criteria for bench testing of stiffness/force, suggesting a comparative or normative standard was applied.)
Packaging	The packaging can protect the System from exposure to all relevant shipping and handling scenarios. Product integrity was maintained during shipping and handling scenarios.
Retention	The device can retain engagement with attachments on posterior teeth while under compression during an active expansion and holding period. Test results met acceptance criteria and performed as intended.
Insertion and Removal Force	Forces required to insert and remove the device are significantly less than the bond force of the attachment on the tooth.
Human Factors & Usability	The device is adequately designed for its intended users, uses, and use environments. Additional device modifications to the user interface were not needed and would not further reduce risk. (Based on available data, the subject device and primary predicate device perform as intended.)
Biocompatibility	The IPE System does not pose any significant biological risks and is considered safe for its intended use in the intra-oral cavity, as per ISO 10993-1 and ISO 7405.
Software Testing	Successful software verification and validation (V&V) testing at the unit, integration, and system level was performed to qualify the orthodontic software component. (This indicates the software met its functional requirements and quality standards, but not necessarily clinical performance metrics as might be seen for a diagnostic AI).
Clinical Performance	An early feasibility study concluded that desired active expansion of the upper jaw width was observed in all subjects. No unanticipated or serious adverse events were reported. Real-world data from commercially available product was also analyzed. (This is more of a qualitative summary of observational findings rather than a formal, quantitative performance study with pre-defined success metrics like sensitivity/specificity).

Regarding the study that proves the device meets the acceptance criteria (specifically concerning the software component, as that's where AI concepts typically apply):

The document describes the software as a "proprietary, 3D Shape generation software" that "enables Align's computer-aided design (CAD) designers to generate the shape and quantity/stages of the device." It clarifies that this is an "internal Align facing only shape generation software which includes software algorithms that are used to determine the shape and calculate the quantity of devices required per the doctor prescribed expansion distance and holding duration." This is a software that designs the physical device based on inputs, not an AI that interprets medical images, flags abnormalities, or assists in diagnosis, which would typically involve the detailed study characteristics you've requested.

Therefore, many of your questions related to multi-reader studies, expert ground truth adjudication for a test set, effect sizes of human improvement with AI, and specific ground truth types (pathology, outcomes data) are not applicable to the description of the software provided in this 510(k) summary, as it's not a diagnostic or AI-assisted diagnostic tool in the typical sense.

Here's an attempt to answer the relevant questions based on the provided text, and state when information is not applicable or provided:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Test Set Sample Size: For the physical device performance tests (durability, stiffness, retention, etc.), specific sample sizes are not provided, only that testing was conducted and met acceptance criteria. For the "Early Feasibility Study," the number of subjects is not specified, only that "desired active expansion of the upper jaw width was observed in all the subjects." For the "real-world data," the sample size is not provided.
Data Provenance: The document does not specify the country of origin. The "Early Feasibility Study" is mentioned, implying a prospective collection for that specific study. The "real-world data" is described as from "commercially available product," suggesting it is retrospective post-market data.

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

This information is not provided because the software's function is for device design generation, not for generating 'ground truth' for medical interpretations or diagnoses that would require expert labeling and adjudication. The "doctor-prescribed expansion amount" is the input to the software, implying the clinician dictates the "ground truth" for the device design.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for the software as described. The software's output is a device design based on physician input, not a diagnostic finding requiring adjudication.

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 MRMC study was done or reported for this device's software. The software's role is not described as an AI assisting human readers in diagnostic tasks.

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

The software's function is described as enabling "CAD designers to generate the shape" based on "doctor-prescribed expansion amount." It's an internal design tool, not a standalone diagnostic algorithm whose performance would typically be evaluated without human input. Software verification and validation (V&V) was performed, which assesses if the software functions as designed from a technical standpoint.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the software, the "ground truth" for its operation is the "digital scan and doctor/dental practitioner's prescription." The software takes these inputs to generate a 3D model. Clinical performance was evaluated by observing "desired active expansion... in all the subjects" and "no unanticipated or serious adverse events reported," which relates to patient outcomes after using the physical device.

8. The sample size for the training set:

Not applicable or provided. The document describes software that generates device shapes based on given inputs, rather than a machine learning model that would require a dedicated training set.

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

Not applicable. The software's function as described does not involve a "training set" in the machine learning sense, where ground truth labels would be established. It is a deterministic design software.

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 & 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.

December 15, 2023

Align Technology, Inc. Sindhura Gaddamanugu Sr. Regulatory Affairs Specialist II 2820 Orchard Parkway San Jose, California 95134

Re: K232887

Trade/Device Name: Invisalign Palatal Expander System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 18, 2023 Received: September 18, 2023

Dear Sindhura Gaddamanugu:

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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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,

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

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Indications for Use

510(k) Number (if known) K232887

Device Name Invisalign Palatal Expander 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)

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Section 7: 510(K) Summary - K232887

Align Technology's Invisalign System Palatal Expander (IPE) System

General Information

510(k) Sponsor	Align Technology, Inc.
Address	2820 Orchard ParkwaySan Jose, CA 95134
FDA Registration Number	2953749
Contact Person	Sindhura GaddamanuguSr. Regulatory Affairs Specialist II, Regulatory AffairsAlign Technology, Inc.
	cc: Shweta DagaDirector, Regulatory AffairsAlign Technology Inc.
Contact Information	Email: sgaddamanugu@aligntech.comPhone: +1 408-470-1000Fax: +1408-470-1010
Date Prepared	September 18, 2023

Name of Modified Device and Name/Address of Sponsor

Name of Device	Invisalign Palatal Expander (IPE) System
Name/Address of Sponsor	Align Technology, Inc.2820 Orchard Parkway, San Jose, CA 95134
Trade/Proprietary Name	Invisalign Palatal Expander (IPE) System
Common Name	Palatal Expander, Sequential
Classification Name	Orthodontic Plastic Bracket
Regulation Number	21 CFR 872.5470
Product Code	NXC
Regulatory Class	II

Primary Predicate Device

Name of Device	Invisalign System
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

ALIGN CONFIDENTIAL

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Name of Device	Dentaurum Expansion Screws
Name/Address of Sponsor	Dentauraum, Inc.
Trade/Proprietary Name	Dentaurum Expansion Screws
Common Name	Retainer, Screw Expansion, Orthodontic
Classification Name	Orthodontic appliance and accessories
Regulation Number	21 CFR 872.5410
Product Code	DYJ
Regulatory Class	I

Secondary Predicate Device

Purpose of the Traditional 510(k) Notice

The purpose of this Traditional 510(k) notice is to request clearance for the Subject device. the Invisalign Palatal Expander (IPE) System. Additionally, this Traditional 510(k) introduces the proprietary, 3D Shape generation software, and labeling documentation associated with the Invisalign Palatal Expander System.

Intended Use/Indications For Use

The intended use of the Subiect device is as follows:

The Invisalign Palatal Expander System is intended for use in the treatment of dental and/or skeletal malocclusion in primary, mixed or permanent dentition.

The Indications for Use of the subject device is as follows:

The Invisalign Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed, or permanent dentition during orthodontic or orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.

The general purpose of the subject device and the primary predicate, i.e. Invisalign System and the secondary predicate device (Dentaurum Expansion Screws) is the treatment of malocclusion and the subject device's intended use falls within the intended use of the predicate devices. The subject device and the primary predicate device are indicated for the treatment of malocclusion. Additionally, the subject device and the secondary predicate device are used for rapid expansion of narrow maxilla. While the Indication for Use is similar, both the subject and primary predicate device have the same intended use that is used in the treatment of dental or skeletal malocclusion in primary, mixed or permanent dentition.

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Device Description

The IPE System consists of the Invisalign Palatal Expanders, Invisalign Palatal Holders, the Attachment Template and the proprietary 3D Shape generation software.

Comparison with Predicate Devices

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

Technological Characteristics Comparison with the Predicate Devices

The IPE System provides an additional method for palate expansion during malocclusion treatment as achieved with the primary and secondary predicate devices. The technological differences are limited to the material, additive manufacturing, and the 3D Software used to deliver a patient-matched device to meet its proposed intended use.

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	Subject DeviceInvisalign PalatalExpander System	PrimaryPredicate DeviceInvisalign System(K220287)	SecondaryPredicate DeviceDentaurumExpansionScrews(K935154)	SubstantialEquivalency
Indication for Use, User Population
IntendedUse	The Invisalign PalatalExpander System isintended for use in thetreatment of dentaland/or skeletalmalocclusion inprimary, mixed orpermanent dentition.	The InvisalignSystem is intendedfor use in thetreatment of dentalor skeletalmalocclusion inprimary, mixedand permanentdentition.	The ExpansionScrew is intendedfor use in thetreatment forpalatal expansionin all dentitiontypes.	Same as primarypredicate deviceSimilar tosecondarypredicate deviceThe subjectdevice's intendeduse falls within theintended use ofthe secondarypredicate device.
Indicationsfor Use	The Invisalign PalatalExpander System isindicated for theorthodontic treatmentof malocclusion. Thesystem is used forrapid expansion andsubsequent holding ofskeletal and/or dentalnarrow maxilla (upperjaw, palate, dentalarch and teeth) withprimary, mixed, orpermanent dentitionduring orthodontic ororthopedic treatmentin children oradolescents. In adults,to be used inconjunction withsurgery or otherinterventions whennecessary.	The InvisalignSystem isindicated for theorthodontictreatment ofmalocclusion.	The device isindicated for caseof transverseunder-developmentof the upper jaw.	Similar to primarypredicate deviceSame as thesecondarypredicate deviceThe subjectdevice and theprimary predicatedevice havesimilar Indicationfor Use and bothare indicated forthe treatment ofmalocclusion.Both the subjectdevice and thesecondarypredicate devicehave the sameindication for useto expand thenarrowmaxilla/upper jaw.
PatientPopulation	Children, Adolescentsand Adults	Children,Adolescents andAdults	All patients forwhom a fixedappliance with anexpansion screwcan be placed aspart of orthodontictreatment.	Same as primarypredicate deviceSimilar tosecondarypredicate deviceThe subjectdevice patient
	Subject DeviceInvisalign PalatalExpander System	PrimaryPredicate DeviceInvisalign System(K220287)	SecondaryPredicate DeviceDentaurumExpansionScrews(K935154)	SubstantialEquivalency
				population is thesame as theprimary predicatedevice and thepopulation is asubset ofsecondarypredicate devicepatient population.
UseLocation	Dental intraoraldevices.	Dental intraoraldevices.	Dental intraoraldevices.	Same as primaryand secondarypredicate devices
OTC orPrescription(Rx) Device	Rx only	Rx only	Rx only	Same as primaryand secondarypredicate devices
Principle ofOperation	Expanders:Sequential expandersapply continuousoutwardpressure/force to themaxilla.	Aligners:Sequentialaligners applycontinuous gentleforce to the teethand/or positionmandible forward.	Hyrax has anexpansion screwsuspended abovethe palatalvault/gingiva. A keyis used to turn theexpansion screws(quarter turn - 90degrees rotation)on a specifiedschedule per thedoctor's discretion,and this keeps thepressure on bothhalves of thejawbone causingthem to widen andmove apart. Thenumber of quarterturns per day isinstructed by thedoctor to thepatient and/orparent/supervisingadult per thetreatment plan forrapid or slowexpansion.	Similar to primaryand secondarypredicate devices.Subject deviceoperates same asprimary predicatedevice in thecontext ofremovability,exertingcontinuous force,and sequentialdevices.Subject deviceand secondarypredicate operatesimilarly regardingseparating themid-palatal sutureand movement ofmaxillary halves.Subject deviceand secondarypredicate deviceoperate similarlyby exertingcontinuous force.
	Subject DeviceInvisalign PalatalExpander System	PrimaryPredicate DeviceInvisalign System(K220287)	SecondaryPredicate DeviceDentaurumExpansionScrews(K935154)	SubstantialEquivalency
	Holders: The palatalholder is a copy of laststage of theexpansion phase.	Retainers: Theretainers are acopy of the laststage of thealigners.Note: InvisalignRetainers are notpart of the primarypredicate deviceInvisalign System(K220287) as theyare classified as aClass I under21CFR872.5525.	The expansionscrew-baseddevice shouldremain in themouth after activeexpansion withoutturning the screwfor approximately 2- 3 months forstabilizationpurposes and toavoid relapse.	Similar to theprimary andsecondarypredicate devicesSubject devicehas the sameprinciple ofoperation ofmaintaining andpreventingmovement usingpassive devicesas both predicatedevices.
	Technological Characterization
Software	Produces 3D-modelfile of the IPE devicesbased on the digitalscan anddoctor/dentalpractitioner'sprescription.3D Software of thesubject device is aninternal Align facingonly shape generationsoftware whichincludes softwarealgorithms that areused to determine theshape and calculatethe quantity of devicesrequired per thedoctor prescribedexpansion distanceand holding duration.	Produces 3D-model file of thePVS impression orthe digital scan.Identifies theindividual teeththat requirestreatment (i.e.,repositioning).Creates atreatment plan(i.e., 3-D modelsthat represent thetreatment plan)which is reviewedby the treatingdental practitionerusing ClinCheck'sdoctor facingfunction to rejector requestmodifications tothe set-up prior toapproval.	Not Applicable	Similar to theprimary predicate.The 3D softwareused in thesubject andpredicate devicesare both used fortreatment planningand designing theshape of thedevice. Thesubject deviceutilized asimplified versionof 3D softwarebased on thepurpose anddesign of thedevice.
Materials	Thermoplasticpolyamide	Thermoplasticpolymer	The screws aremade of stainlesssteel (DIN 1.4301)	Similar to theprimary predicatedevice.
	Subject DeviceInvisalign PalatalExpander System	PrimaryPredicate DeviceInvisalign System(K220287)	SecondaryPredicate DeviceDentaurumExpansionScrews(K935154)	SubstantialEquivalency
Durability	Durability was testedto verify theperformance of theIPE device. All IPEdevices maintainedthe engagement onattachments, withoutdeformation, cracks,chips or breaks.	Performance TestingNo new durabilitytesting wasrequired with theprimary predicatedevice pre-marketnotification(K220287).Durability testingwas performed onpreviously clearedInvisalign Systemand testing resultsmet all acceptancecriteria.	Unknown	Same as primarypredicate device
Stiffness/Forcesystem	The subject devicewas tested to verifythat the device isstructurally stiff andcan deliver therequired force in thelateral direction on theposterior teeth. Thetest results met theacceptance criteriaand performed asintended.	No new forcesystem testing wasrequired with theprimary predicatedevice pre-marketnotification(K220287).Force mechanicalverification testingdemonstrated withpreviously clearedInvisalign Systemprovides adequateforce systems onthe dentition for itsintended use.	The mechanicalbehavior(stiffness/force) ofHyrax was used asone of theacceptance criteriafor the subjectdevice benchtesting.	Similar to PrimaryPredicate deviceSame as secondarypredicate device
Packaging	The subject devicewas tested to validatethat the packagingcan protect theSystem fromexposure to allrelevant shipping andhandling scenarios.The testing confirmedthat the productintegrity wasmaintained during	No new packagingvalidation testingwas required withthe primarypredicate devicepre-marketnotification(K220287).The Packagingvalidation testingon previously	Unknown	Similar to PrimaryPredicate deviceBoth the subjectand primarypredicate devicesuse the sameprimarypackaging, andpackaging testingon the subjectdevice confirmed
Subject DeviceInvisalign PalatalExpander System	PrimaryPredicate DeviceInvisalign System(K220287)	SecondaryPredicate DeviceDentaurumExpansionScrews(K935154)	SubstantialEquivalency
shipping and handlingscenarios.	cleared InvisalignSystemdemonstrated thatthe device integritywas maintainedduring the variousshipping andhandlingscenarios.		that deviceintegrity ismaintained duringall relevantshipping andhandlingscenarios
Retention	The subject devicewas tested to verifythat the device canretain engagementwith attachments onposterior teeth whilethe device is undercompression duringan active expansionand holding period.The test results metthe acceptancecriteria and performedas intended.	No new testingwas required withthe primarypredicate devicepre-marketnotification(K220287).Retention testingperformed onpreviously clearedInvisalign Systemdemonstrated thatthe deviceperformed asintended.	Unknown	Similar to_PrimaryPredicate device
InsertionandRemovalForce	The Insertion andRemoval Force testwas conducted toverify that the forcesrequired to insert andremove device aresignificantly less thanthe bond force of theattachment on thetooth.	No force systemtesting wasrequired with theprimary predicatedevice pre-marketnotification(K220287).The testingperformed onpreviously clearedInvisalign Systemdemonstrated thatthe deviceperformed asintended.	Unknown	Similar to_PrimaryPredicate device
HumanFactors &Usability	Human factors &Usability testing wasconducted on thesubject device tovalidate that it is	No human factors& usabilityvalidation testingwas required forthe primary	Unknown	Similar to_PrimaryPredicate deviceBased onavailable data
	Subject DeviceInvisalign PalatalExpander System	PrimaryPredicate DeviceInvisalign System(K220287)	SecondaryPredicate DeviceDentaurumExpansionScrews(K935154)	SubstantialEquivalency
	adequately designedfor its intended users,uses and useenvironments	predicate devicepre-marketnotification(K220287).Human Factors &Usability validationon previouslycleared InvisalignSystem has beenfound to beadequatelydesigned for theintended users,uses, and useenvironments.		both the subjectdevice andprimary predicatedevice perform asintended andadditional devicemodifications tothe user interfaceare not neededand would notfurther reducerisk.
ClinicalTesting	Not Applicable.An early feasibilitystudy was conductedwhich concluded thatdesired activeexpansion of theupper jaw width wasobserved in all thesubjects. There wereno unanticipated orserious adverseevents reported fromthis study.Additionally, real-world data was alsoanalyzed fromcommerciallyavailable product.	Not Applicable	Not Applicable	Similar to primarypredicate andsecondarypredicate devices.The subjectdevice is a ClassII medical deviceand clinical testingwas not warrantedto supportsubstantialequivalency withthe primary andsecondarypredicate devices.

Table 7-1: Substantial Equivalency Overview

ALIGN CONFIDENTIAL

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ALIGN CONFIDENTIAL

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Performance Data

The IPE System underwent a complete set of functional and performance testing, including, durability, expander fatigue/insertion & removal, bioburden, and packaging validation testing. Clinical performance of the IPE System was also evaluated in an early feasibility study and realworld data post-market study. Based on the performance testing outcomes, the subject device,

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the IPE System is substantially equivalent to its predicates and there are no new risks from the differences between the subject device and the predicate devices.

Biocompatibility

Biocompatibility testing for the proposed IPE System was completed and assessed in accordance with ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process, and ISO 7405, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. The results demonstrate that the IPE System does not pose any significant biologicals risks and is considered safe for its intended use in the intra-oral cavity.

Software Testing

In accordance with IEC 62304. Medical device software - Software life cycle processes; successful software verification and validation (V&V) testing at the unit, integration, and system level was performed to qualify the orthodontic software component of the subject device.

Substantial Equivalence

The subject device is similar to its predicate devices in that it has:

intended use, same as primary predicate device and similar to secondary predicate o device;
. indications for use, similar to primary predicate device and same as secondary predicate device:
principles of operation, similar to both predicate devices; and
technological characteristics, similar to primary predicate device ●

The differences in the indications for use, principles of operation and technological characteristics between the subject device and its predicate devices do not raise different questions of safety or efficacy. Therefore, the subject device is found to be substantially equivalent to the legally marketed primary predicate device, Invisalign System (K220287) and secondary predicate device, Dentaurum Expansion Screws.

Conclusion

Align Technology's Invisalign Palatal Expander (IPE) System has the same intended use and similar indications for use as the previously cleared primary predicate, Invisalign System (K220287). The IPE System has similar intended use and same indications for use as the secondary predicate device Dentaurum Expansion Screws. The difference in principles of operation and technological characteristics between the subject device and the predicate devices were evaluated using standard test methods and do not raise new issues of safety or effectiveness. Performance data (bench and clinical) and biocompatibility testing demonstrate that the subject device is as safe and effective as both predicate devices. Thus, the

Invisalign Palatal Expander (IPE) System is substantially equivalent to both predicate devices.

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.