The SoftSmile Vision is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of SoftSmile Vision requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

Device Description

SoftSmile Vision is orthodontic planning and treatment simulation software for use by dental professionals. SoftSmile Vision imports patient 3-D digital scans and allows the user to plan the orthodontic treatment needs of the patient and develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate by a manufacturer sequential aligner trays or retainers.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state specific, quantifiable acceptance criteria or a direct table comparing them to reported device performance. Instead, it relies on a statement of meeting acceptance criteria established during software verification and validation. The primary form of "performance" discussed is the software functioning as intended and being substantially equivalent to the predicate device.

Therefore, a table with specific performance metrics cannot be generated from the given text.

The document states:

"All test results met acceptance criteria, demonstrating the Vision software performs as intended, raises no new or different questions of safety or effectiveness and is substantially equivalent to the predicate device."

This is a general statement of compliance rather than a detailed report of performance against predefined thresholds.

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

The document does not specify the sample size used for the test set. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The study described is primarily focused on software verification and validation, not clinical performance reviewed against expert-derived ground truth.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for a test set. This type of method is typically used when human readers or experts are involved in establishing ground truth for evaluating diagnostic or predictive devices, which is not the focus of the described "study."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on software validation relative to a predicate device, not on comparing human performance with and without AI assistance. Therefore, there is no effect size reported for human readers improving with AI.

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

Yes, inferentially. The "study" described is a "Software and integration verification and validation testing." This type of testing assesses the algorithm's performance and functionality in a standalone manner, ensuring it operates as designed, without human intervention during the core processing. The statement "demonstrating the Vision software performs as intended" implies standalone evaluation of the software's functions.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used in the context of clinical outcomes or expert consensus. Given the nature of a software verification and validation study, the "ground truth" would likely be defined by:

Software requirements specifications: The expected behavior and output of the software.
Predicate device behavior: The established functionality and output of the legally marketed predicate device (ULab Systems UDesign (K171295)).
Engineering specifications: Correctness of calculations, data handling, and file exports according to predefined digital standards.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is consistent with the device being a "front-end" software for treatment planning and simulation, rather than a machine learning model that requires a large training dataset for inference.

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

Since no training set is mentioned, there is no information on how its ground truth might have been established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 21, 2021

SoftSmile, Inc. % Allyson Mullen Director Hyman, Phelps & McNamara 700 Thirteenth Street NW. Suite 1200 Washington, District of Columbia 20005

Re: K212770

Trade/Device Name: Vision Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: September 29, 2021 Received: September 30, 2021

Dear Allyson Mullen:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212770

Device Name Vision

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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510(k) Summary: K212770

In accordance with 21 C.F.R. § 807.92 the following summary of information is provided:

DATE: December 13, 2021

SUBMITTER:

SoftSmile, Inc. 16192 Coastal Highway, Lewes, DE 19958

PRIMARY CONTACT PERSON:

Allyson B. Mullen Hyman, Phelps, & McNamara, P.C. T 202-737-9639 F 202-737-9329

SECONDARY CONTACT PERSON:

Khamzat Asabaev CEO T (929) 289-8777

DEVICE:

TRADE NAME: Vision COMMON/USUAL NAME: Orthodontic Software CLASSIFICATION NAMES: Orthodontic Plastic Bracket REVIEW PANEL: Dental PRIMARY PRODUCT CODE: PNN ADDITIONAL PRODUCT CODE: LLZ CLASSIFICATION REGULATION: 21 C.F.R. § 872.5470 CLASS: II

PREDICATE DEVICE(S):

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DEVICE DESCRIPTION:

INDICATIONS FOR USE:

TECHNOLOGY:

The proposed Vision software has similar indications for use and uses the same fundamental technology as the legally marketed predicate devices to which substantial equivalency is claimed, the ULab Systems UDesign software (K171295).

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	Predicate Device	New Device
	ULab Systems UDesign	SoftSmile, Inc. Vision
	(K171295)	(K212770)
Indications for Use	The ULab Systems UDesign is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the ULab Systems UDesign requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.	The SoftSmile Vision is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of SoftSmile Vision requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.
	Predicate Device	New Device
	ULab Systems UDesign	SoftSmile, Inc. Vision
	(K171295)	(K212770)
Intended Use	Used by dental professionals in orthodontic treatment planning (before, during and after treatment) Management of patients and models Inspection, measurement and analysis of orthodontic models Treatment simulation Virtual appliance preparation, handling and export Provides device output	Used by dental professionals in orthodontic treatment planning (before, during, and after treatment) Management of patients and models Inspection, measurement, and analysis of orthodontic models Treatment simulation Virtual preparation of dental casts, handling and export Provides digital file
SoftwareEnvironment ofUse	Dental office	Dental office
SoftwareIntended User	Dental professional	Dental professional
Intended PatientPopulation	Patients with malocclusion	Patients with malocclusion
TargetAnatomic Area	Maxilla, Mandible	Maxilla, Mandible
Type of PatientContact	None	None
Principle ofOperation	Apply digital imaging tools for use in orthodontic case archiving, diagnosis, treatment planning and CAD design of customized appliances. The system supports the followign types of digital data: STL, JPG, BMP, PNG.	Apply digital imaging tools for use in orthodontic case archiving, treatment planning and CAD design of customized appliances. The system supports the followign types of digital data: STL, OBJ, JPG, BMP, PNG.The subject device is available in OBJ file format whereas the predicate is not.
	Predicate DeviceULab Systems UDesign(K171295)	New DeviceSoftSmile, Inc. Vision(K212770)
Technicalattributes	Supported PC formats: Windows 64-bit RAM: 4GB required; 8 GB recommended Monitor resolution: 1024×768 24 bit color (True Color) (Recommended – 1920 x 1080 Full HD monitor) Video Card Memory: Directx 11 or Later Compatible (Recommended – Dedicated Nvidia 1 GB) Available HDD Space: 2 GB CPU: Intel i3 3rd Generation Processor or Equivalent (Recommended – IntelCore i5 4th Generation or equivalent)	Minimum Requirements: Supported PC formats: Windows 10 64-bit RAM: 4 GB Monitor Resolution: 1280x800 or similar Video Card Memory: 2 GB or more discrete graphics card Available HDD Space: 120 GB or more CPU: IntelCore i3, AMD FX-4300 or higher
Management ofpatient/case basedata	Allows creating, editing, deleting, copying patient/case data	Allows creating, editing, deleting, copying patient/case data
Collection ofInput	Surface scan for intra-oral scanner Surface scan from STL file 2D overlay: PNG, JPG, BMP	Surface scan for intra-oral scanner Surface scan from STL or OBJ file 2D overlay: PNG, JPG, BMP
Alignment ofInput	Aligning surface scan image Alignment of 2D overlays (e.g., ideal arch)	Aligning surface scan image Alignment of 2D overlays (e.g., ideal arch)
Measurement ofInput	3D measurement toolbox	3D measurement toolbox
	Predicate Device	New Device
	ULab Systems UDesign	SoftSmile, Inc. Vision
	(K171295)	(K212770)
Analysis ofInput	Arch shape Tooth width Bolton Space analysis Overjet/overbite Occlusion map	Arch shape Tooth width Bolton Space analysis Overjet/overbite Occlusion map
Treatmentsimulation	3D simulation	3D simulation
Virtualappliance design	Orthodontic dental cast search Orthodontic dental cast virtual preparation Orthodontic dental cast design Orthodontic dental cast export	Orthodontic dental cast search Orthodontic dental cast virtual preparation Orthodontic dental cast design Orthodontic dental cast export
Virtualapplianceoptions	Dental casts	Dental casts

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DETERMINATION OF SUBSTANTIAL EQUIVALENCE NON-CLINICAL TESTS:

Software and integration verification and validation testing were performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005) for a moderate level of concern software. The testing includes validation of implemented mitigations related to device hazards identified in the risk management procedures. All test results met acceptance criteria, demonstrating the Vision software performs as intended, raises no new or different questions of safety or effectiveness and is substantially equivalent to the predicate device.

CONCLUSION:

SoftSmile, Inc. considers the Vision software to be 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.