The Angel Align System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. The Angel Align System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion. The 3D software generates the model of a provisional treated state and then creates a series of models that represent intermediate teeth states. The dental practitioner reviews these models to view, edit or approve the orthodontic treatment plan. The dental practitioner has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, the series of custom-made aligners are manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.

AI/ML Overview

This FDA 510(k) summary focuses on demonstrating substantial equivalence of the "Angel Align System" to a predicate device (Invisalign - K143630), rather than a study proving the device meets acceptance criteria in the way a de novo or PMA would. Therefore, much of the requested information regarding specific acceptance criteria and detailed study designs for performance is not explicitly provided in this document.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are not defined in this 510(k) summary (which is typical for a substantial equivalence claim for a physical device like aligners), this table will describe the types of tests performed and their outcomes in relation to establishing equivalence.

Acceptance Criteria Category	Reported Device Performance (Angel Align System)
Intended Use	Same as predicate (alignment of teeth during orthodontic treatment of malocclusion).
3-D Software Description	Same as predicate (uses scan to generate treated models, allows practitioner review/modification, converts files for aligner production).
Mode of Operation for 3-D Software	Same as predicate (produces 3D-model, identifies teeth for treatment, creates treatment plan, allows practitioner review/modification).
Material	Primarily uses 0.03" thick, thermoformed polyurethane. (Predicate uses this OR multilayer aromatic thermoplastic polyurethane/copolyester). This minor difference was deemed not to impact safety or efficacy.
Mode of Use	Same as predicate (each appliance worn for ~2 weeks.
Description of Appliance Application	Same as predicate (removable).
Manufacturing Method	Same as predicate (digital model from scan/PVS impression, software generates treated states, rapid prototyping for physical models, thermoforming to produce aligners).
Software Validation	PASS
Design Verification and Validation	PASS
ISO 10993 (Biocompatibility)	PASS
Clinical Performance (Post-Market Study)	PASS (provides evidence of safety and effectiveness for all tooth movements and demonstrates substantial equivalence).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated for specific non-clinical or clinical studies. The document only mentions "non-clinical performance tests" and "post market clinical data".
Data Provenance: Not explicitly stated (e.g., country of origin). The clinical data is referred to as "post market clinical data," implying it would be collected after the predicate device was on the market and potentially includes data from various regions where the predicate was used. It is retrospective in the sense that data from an already marketed device (the predicate, or market data related to similar aligner use) was likely utilized to support the equivalence claim, but the specific nature of the clinical "study" is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a 510(k) for a physical orthodontic aligner device, direct human expert ground truth establishment for a test set as one might see in an AI/imaging device is not typically detailed in this manner. The "ground truth" here is implied by the established orthodontic principles and the clinical outcomes observed in patients treated with similar devices.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to this type of device and submission. Adjudication methods are more common in clinical trials evaluating specific endpoints with subjective interpretation, particularly relevant for AI/imaging device performance assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of this 510(k). The Angel Align System is a physical orthodontic aligner, and its accompanying software is for treatment planning and aligner design, not a diagnostic AI tool that would assist human "readers" (like radiologists interpreting images). Therefore, the concept of "human readers improve with AI" does not directly apply here. The software is a tool for the dental practitioner, not an interpretative aid that independently makes diagnoses requiring reader performance comparison.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The 3D software component of the Angel Align System generates a provisional treated state and a series of intermediate teeth states, but it explicitly states: "The dental practitioner reviews these models to view, edit or approve the orthodontic treatment plan. The dental practitioner has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication."
This indicates that the software is not standalone in its clinical application; it operates with a human-in-the-loop (the dental practitioner) who reviews and approves the outputs before aligner fabrication. Therefore, a standalone performance study in the context of a fully autonomous AI system was not described or performed as the device requires human interaction and approval.

7. The Type of Ground Truth Used

For the technical and performance characteristics, the "ground truth" is established by engineering and material science standards (ISO10993, software validation, design verification) relative to the predicate device.
For clinical performance, the "ground truth" is based on clinical outcomes data from a "post market clinical study" which demonstrated safety and effectiveness for tooth movements, inferring successful orthodontic corrections in patients. This aligns with the accepted clinical efficacy for clear aligner systems.

8. The Sample Size for the Training Set

This information is not provided. The software generates treatment plans based on a scan of the patient's teeth and likely relies on algorithms and biomechanical models, not necessarily a "training set" in the machine learning sense that would require a quantified sample size for training. If the software utilizes any machine learning component (which is not explicitly detailed but is common in 3D modeling), the training data details are not disclosed.

9. How the Ground Truth for the Training Set Was Established

This information is not provided as a "training set" in the typical AI sense is not explicitly mentioned with its ground truth establishment in this document. The software functions based on established principles of orthodontics and 3D modeling, with human oversight for approval.

Summary

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Smile Development Corp Ian Kitching President & CEO 7179 Cherrywood Ct Highland, California 92346 January 19, 2018

Re: K171674

Trade/Device Name: Angel Align System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: December 6, 2017 Received: December 11, 2017

Dear Ian Kitching:

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. 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 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5. Indications for Use Statement (FDA Form 3881)

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
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Indications for Use

510(k) Number (if known)	K171674
Device Name	Angel Align
Indications for Use (Describe)	Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

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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6. 510(k) Summary
510(k) SUMMARY
510(k) Owner	Smile Development Corp.7179 Cherrywood CourtHighland, CA 92346Phone: 408.621.1152
Contact person	Ian KitchingSmile Development Corp.7179 Cherrywood CourtHighland, CA 92346Phone: 408.621.1152ian@smiledevcorp.com
Submission Date	December 11, 2017
Product Code:Common Name	Orthodontic Plastic Brackets
Trade Name	Angel Align System
Classification Name	aligner, sequential
Regulation	872.5470
Class	Class II
Panel	Dental
Product Code	NXC
Predicate	K143630Invisalign - Align Technology, Inc.
Description

iption

The Angel Align System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion.

The 3D software generates the model of a provisional treated state and then creates a series of models that represent intermediate teeth states. The dental practitioner reviews these models to view, edit or approve the orthodontic treatment plan. The dental practitioner has the option to

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reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, the series of custom-made aligners are manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.

Indications for Use

Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Technological Characteristics

The predicate and the Angel Align System were compared in the following areas and found to have similar technological characteristics and to be equivalent:

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	Angel Align System	K143630
Intended UseStatement	SAMEThe Angel Align System isindicated for the alignment ofteeth during orthodontic treatmentof malocclusion.	SAMEThe Invisalign System is indicatedfor the alignment of teeth duringorthodontic treatment ofmalocclusion.
3-D SoftwareDescription	SAMEThe Angel Align 3-D Software usesa scan of a PVS impression or adigital scan (which represents anuntreated state) to generate theimage of a final, provisionaltreated state and then interprets aseries of images that representintermediate teeth states. Thedental practitioner then reviewsthese images and has the option toreject or request modifications tothe set-up prior to approving it foraligner fabrication. Once thedental practitioner approves thetreatment plan, the softwareconverts the files to produce theseries of custom-made aligners	SAMEThe Align 3-D Software uses a scanof a PVS impression or a digital scan(which represents an untreatedstate) to generate the image of afinal, treated state and theninterprets a series of images thatrepresent intermediate teeth states.The dental practitioner then reviewsthese images and has the option toreject or request modifications to theset-up prior to approving it foraligner fabrication. Once the dentalpractitioner approves the treatmentplan, the software converts the filesto produce the series of custom-made aligners
Mode ofOperation for 3-DSoftware	SAMEAngel Align System 3-D softwareperforms the following operations:Produce 3D-model file ofthe PVS impression ordigital scan. Identifies the individualteeth that will requiretreatment (i.e.repositioning). Creates a treatment plan(i.e. 3-D models thatrepresent the treatmentplan). The treating dentalpractitioner reviews theseimages using software andhas the option to reject orrequest modifications tothe set-up prior to	SAMEInvisalign system 3-D softwareperforms the following operations:Produce 3D-model file of thePVS impression or digitalscan. Identifies the individualteeth that will requiretreatment (i.e.repositioning). Creates a treatment plan (i.e.3-D models that representthe treatment plan). Thetreating dental practitionerreviews these images usingClinCheck software and hasthe option to reject orrequest modifications to theset-up prior to approval.
Material		The Invisalign System uses either:
	SAME0.03" thick, thermoformedpolyurethane	DIFFERENT1. 0.03" thick, Multilayer aromaticthermoplastic polyurethane /copolyester.or:SAME2. 0.03" thick, thermoformedpolyurethane
Mode of Use	SAMEEach appliance is worn by thepatient as determined by thedental practitioner, generally 2weeks prior to being replaced bythe next aligner in sequence.	SAMEEach appliance is worn by the dentalpractitioner, generally 2 weeks priorto being replaced by the next alignerin sequence.
Description ofApplianceApplication	SAMERemovable	SAMERemovable
ManufacturingMethod	SAMEA digital model of the patient'steeth is created from either CTscanning a PVS impression ordirectly from an intraoral scan ofthe patient's teeth. From thedigital model, following a dentalpractitioner's prescription, thesoftware generates modeltransforms describing theprovisional final, treated state andthen interpolates a series of modeltransforms that representintermediate states of alignment.The resulting computer "setups"relay this information to rapidprototyping machines that producephysical positive models. Thealigners are produced bythermoforming on each physicalmodel to fabricate the sequence ofaligners.	SAMEA digital model of the patient's teethis created from either CT scanning aPVS impression or directly from anintraoral scan of the patient's teeth.From the digital model, following adental practitioner's prescription, thesoftware generates model transformsdescribing the final, treated state andthen interpolates a series of modeltransforms that representintermediate states of alignment.The resulting computer “setups”relay this information to rapidprototyping machines that producephysical positive models. Thealigners are produced bythermoforming on each physicalmodel to fabricate the sequence ofaligners.

Device Comparison Table

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The predicate and the Angel Align System were compared in the following area and found to have minor different technological characteristics. The following differences have been determined to not have any impact on the safety or efficacy of the Angel Align System:

	Angel Align System	K143630
Material		The Invisalign System uses either:
		DIFFERENT1. 0.03" thick, Multilayer aromaticthermoplastic polyurethane /copolyester.
	SAME0.03" thick, thermoformedpolyurethane	or:SAME2. 0.03" thick, thermoformedpolyurethane

The following non-clinical performance tests were conducted:

Software Validation	PASS
Design Verification and Validation	PASS
ISO10993	PASS

Conclusions from non-clinical performance data

After performing non-clinical performance studies, the data shows that the Angel Align System is substantially equivalent to the predicate as a sequential aligner.

The following post market clinical data was submitted for clinical performance data:

Post-Market Study	PASS
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Conclusions from the clinical data

The data provides evidence of safety and effectiveness for all tooth movements and demonstrates that the Angel Align System is substantially equivalent to the predicate as a sequential aligner.

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.