3D Smile Predict aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion.

Device Description

The 3D Smile Predict aligner system is a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial state to a different end state using a software-generated sequence of intermediate states. 3D Smile Predict Aligners sequentially reposition teeth by way of continuous gentle force.

A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop treatment plans. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health professional's prescription.

The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.

Once approved, the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. 3D Smile USA, Inc produces the aligner trays by thermoforming a plastic sheet over each model in the treatment plan. The aligner trays are sent to the dental health professional who then delivers them to the patient, confirming fit and design of the first stage of treatment. Additional trays are used sequentially by the patient to gradually move the teeth to the desired position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.

AI/ML Overview

The provided text describes the 3D Smile Predict aligner system, which is a medical device. The document is primarily a 510(k) summary, aimed at demonstrating substantial equivalence to a predicate device. As such, it does not contain information about acceptance criteria or a study proving the device meets specific performance acceptance criteria for an AI/algorithm-driven component, as would be expected for a device with an AI/algorithm performing diagnostic or treatment planning functions independently.

The "3D Smile Predict" device is an orthodontic aligner system. While it uses "specialized orthodontic CAD/CAM software" to develop treatment plans and "interpret a series of images that represent intermediate teeth states," the crucial aspect is that "The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced." This indicates that the software is a tool for the dental professional, and the final decision-making power rests with the human expert.

Therefore, the acceptance criteria and detailed study proving the device meets acceptance criteria regarding AI/algorithm performance are not present in this document because the AI/algorithm component is not making independent, unreviewed decisions. The document focuses on demonstrating substantial equivalence of the aligner system (the physical device and its manufacturing process) to a predicate device, not on validating the performance of an AI model that would otherwise require such rigorous testing.

Based on the provided text, here's what can be extracted (and what is explicitly not present):

1. A table of acceptance criteria and the reported device performance:
* Not provided in the context of AI/algorithm performance.
* The document mentions "All measurements were within the acceptance criteria" for a manufacturing validation demonstrating dimensional accuracy of 3D printed molds and aligner adaptation. However, no specific numerical acceptance criteria or reported values are presented in a table for this.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Not applicable for AI/algorithm performance testing as described in a traditional AI regulatory submission.
* The document refers to a "manufacturing validation" but doesn't specify sample sizes for that process or for any data used by the software's internal algorithms beyond the general description of "a scan of a PVS impression, physical or a digital scan."

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):
* Not applicable/not provided. The "ground truth" for the treatment plan is the "prescribing doctor's instructions" and their "review and approval" of the software-generated plan. This is a human-in-the-loop system, not an AI making independent diagnoses or treatment recommendations requiring external ground truth validation for its output.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable/not provided.

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, an MRMC study was not done or required. The software is described as a tool that generates a plan for review and approval by a dental professional, not as an AI providing assistance that demonstrably improves human reader performance that would necessitate such a study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No, a standalone performance study was not done or required. The device clearly states that the "prescribing doctor reviews and approves" the treatment plan. Therefore, it is explicitly a human-in-the-loop system, not a standalone AI diagnostic or treatment planning tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The ground truth for the "treatment plan" is the prescribing doctor's clinical judgment and approval. The software generates "intermediate teeth states" based on a "final, provisional treated state" (which itself is likely defined by a dental professional), and the doctor "reviews these images and has the option to reject or request modifications... prior to approving it."

8. The sample size for the training set:
* Not provided. Given the description of the software as a CAD/CAM tool for generating treatment plans that are then approved by a doctor, it's not described as a deep learning or AI model trained on a large dataset in the way a diagnostic AI would be. If there is an underlying algorithm, its training set size is not disclosed.

9. How the ground truth for the training set was established:
* Not provided. Similar to point 8, the document does not describe the training methodology or ground truth establishment for any "training set."

In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence for an orthodontic aligner system. It describes the software as a CAD/CAM tool facilitating treatment planning that requires definitive human review and approval. Consequently, the rigorous testing and reporting related to AI/algorithm performance (acceptance criteria tables, standalone performance, MRMC studies, ground truth establishment for AI training/testing) that would be expected for a device with an autonomous or high-risk AI component are not present because they are not applicable to the described functioning and regulatory pathway of this particular device.

Summary

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February 24, 2020

Image /page/0/Picture/1 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below.

3D Smile USA, Inc % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K200214

Trade/Device Name: 3D Predict Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: January 24, 2020 Received: January 28, 2020

Dear Prithul Bom:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

For Srivinas 'Nandu' Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Summary 3D Smile USA, Inc 3D Smile Predict 12/24/2019

5.1 ADMINISTRATIVE INFORMATION

Manufacturer Name	3D Smile USA, Inc
	3675 Market Street
	Suite #200
	Philadelphia, PA 19104
	USA
Telephone:	+1 (920) 332 4344
Fax:	n/a

Official Contact	Marina Domracheva, CEO
Email:	marina.domracheva@3d-smile.com

5.2 DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	3D Smile Predict
Common Name:	Aligners, sequential

Classification Name:	Orthodontic Plastic Bracket
Classification Regulations:	21 CFR 872.5470
Device Class:	Class II
Product Code:	NXC
Review Panel:	Dental Products Panel
Reviewing Branch:	Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)Dental Devices (DHT1B)

PREDICATE DEVICE INFORMATION 5.3

The devices within this submission are substantially equivalent in indications, intended use and design principles to the following predicate and reference devices:

510(k)	Predicate Device Name	Company Name
K191990	OSW Aligner System	OSW Manufacturing, LLC

5.4 DEVICE DESCRIPTION

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The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.

The technology is identical to that used by the Predicate device, OSW Aligner System (K191990) and a number of other sequential aligner systems currently being legally marketed.

5.5 INDICATIONS FOR USE

3D Smile Predict aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion.

EQUIVALENCE TO MARKETED DEVICE 5.6

Overall, the Subject device is substantially equivalent to the Predicate device with respect to Indications for Use and technological principles. The Comparison table below compares parameters and characteristics of the Subject device and Predicate/reference devices.

Parameter	Subject Device	Predicate Device
Subject Device	3D Smile Predict3D Smile USA, Inc	OSW Aligner SystemOSW Manufacturing, LLCK180241
Regulation #	21 CFR 872.5470	21 CFR 872.5470
Classification Name	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket
Product Code	NXC	NXC
Classification	Class II	Class II
Indications for Use	3D Smile Predict aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion.	OSW Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Mode of action	Orthodontic movement occurs through continuous gentle forces applied to the dentition as each tooth follows the programmed displacement based on a doctor's prescription.	Orthodontic movement occurs through continuous gentle forces applied to the dentition as each tooth follows the programmed displacement based on a doctor's prescription.
Method of use	Each appliance is worn by the patient as determined by the dental practitioner, generally 2 weeks prior to being replaced by the next aligner in sequence.	Each appliance is worn by the patient as determined by the dental practitioner, generally 2 weeks prior to being replaced by the next aligner in sequence.
3D SoftwareDescription	The 3D Smile Predict 3-D Software uses a scan of a PVS impression, physical or a digital scan (which represents an untreated state) to generate the image of a final, provisional treated state and then interprets a series of images that represent intermediate teeth states. The dental practitioner then reviews these images and has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the dental practitioner approves the treatment plan, the software converts the files to produce the series of custom-made aligners	The OSW Manufacturing 3-D Software uses a scan of a PVS impression or a digital scan (which represents an untreated state) to generate the image of a final, provisional treated state and then interprets a series of images that represent intermediate teeth states. The dental practitioner then reviews these images and has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the dental practitioner approves the treatment plan, the software converts the files to produce the series of custom-made aligners

Predicate Device Comparison Table

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Parameter	Subject Device	Predicate Device
	3D Smile Predict	OSW Aligner System
	3D Smile USA, Inc	OSW Manufacturing, LLC
		K180241
Function of the 3Dsoftware	The 3D Smile 3-D Software performs the followingoperations:• Produce 3D-model file of the patient's dentitionfrom a digital scan.• Generates a treatment plan (i.e. 3-D models thatrepresent the treatment plan) called a 3D plan basedon the prescribing doctor's instructions. The treatingdental practitioner reviews these images using 3DSmile software and has the option to reject orrequest modifications to the set-up prior toapproval.	OSW Aligner System 3-D software performs thefollowing operations:• Produce 3D-model file of the PVS impression ordigital scan.• Identifies the individual teeth that will requiretreatment (i.e. repositioning).• Creates a treatment plan (i.e. 3-D models thatrepresent the treatment plan). The treating dentalpractitioner reviews these images using OSWDPsoftware and has the option to reject or requestmodifications to the set-up prior to approval.
Material	Thermoplastic	0.03" thick, thermoformed polyurethane
Appliance Application	Removable	Removable
Design	Image: 3D Smile Predict Aligner	Image: OSW Aligner System
Biocompatible	Yes	Yes
OTC or Rx	Rx	Rx
Sterile	Non-sterile	Non-sterile

The wording of the Indications for Use of the Subject device is slightly different than that of the Predicate device. At this time, the Subject device is indicated for patients with permanent dentition. This does not change the intended use of both Subject and Predicate devices to be used in the alignment of teeth during orthodontic treatment of malocclusion.

5.7 TECHNOLOGICAL CHARACTERISTICS

Orthodontic tooth movement occurs through forces applied to the teeth by the appliance as each tooth follows the predetermined displacement based on a dental health professional's prescription. The Subject device mode of action and method of use are identical to the Predicate device and supports a determination of substantial equivalence.

Even if the specific features or process of the Software used in treatment planning differs, the use of Software in treatment planning supports a determination of substantial equivalence. Most importantly, both verified and validated software programs rely on the prescribing doctor's approval of the treatment plan. The Subject and Predicate devices are both fabricated of a non-sterile, biocompatible thermoplastic material which supports a determination of substantial equivalence.

5.8 PERFORMANCE DATA

Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.

A manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for 3D Smile Predict Aligners. Three critical aspects of the manufacturing process were assessed for accuracy: 3D printed molds, thermoformed aligner adaptation to the mold, thermoformed aligner to the software output.

Inspection software was used to perform point-to-point and critical displacement measurements.

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All measurements were within the acceptance criteria. These test have met the pre-established acceptance criteria to demonstrate dimensional accuracy.

An aligner fit validation was performed to confirm fit of aligners on the patient.

5.9 CLINICAL TESTING

The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. There no clinical testing is required to support 3D Smile Predict Aligners, as the Indications for Use is equivalent to the Predicate device, which also was not subject to clinical testing. No clinical data is included in this submission.

5.10 BIOLOGICAL TESTING

Biocompatibility testing for the aligner material, the only patient contacting material, was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". The results of the tests satisfy the requirements of the study protocols and comply with ISO 10993-1 for the intended use.

The following biological tests were performed:

Biological Endpoint	Relevant Standard
Cytotoxicity	ISO 10993-5:2009
Sensitization	ISO 10993-10:2010
Irritation	ISO 10993-10:2010
Subacute/SubChronic Toxicity	ISO 10993-11:2006
Genotoxicity	ISO 10993-3:2014

5.11 CONCLUSION

Overall, the Indications for Use statement for the Subject and Predicate devices are substantially equivalent.

Overall, the Technological Characteristics, Materials, Prescription Use and Non-sterile status of the Subject device are substantially equivalent to the Predicate device. The use of Software to produce the Subject and Predicate devices is substantially equivalent.

Overall, the 3D Smile Predict aligners are substantially equivalent to the Predicate device.

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.