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 travs 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 plamed/desired treatment objectives. The use of ULab Systems UDesign requires 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

The ULab Systems UDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. UDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly 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 sequential aligner trays or retainers.

AI/ML Overview

The provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the typical sense of a clinical performance study. Instead, it discusses the software validation and verification.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance Study Information

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

The document states: "All test results met acceptance criteria, demonstrating the ULab Systems UDesign performs as intended, raises no new or different questions of risk and is substantially equivalent to the predicate device."

Acceptance Criteria: Not explicitly detailed in the document. It mentions "acceptance criteria" generally for software and integration verification and validation testing, but specific metrics (e.g., accuracy percentages, error margins for tooth movement) are not provided.
Reported Device Performance: Again, not explicitly detailed. The statement is a general affirmation that the software performed as intended during the validation process. There are no quantitative performance metrics (e.g., this software can predict tooth movement with X% accuracy).

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

Sample Size for Test Set: Not specified. The document does not refer to a "test set" in the context of patient data, but rather "testing" for software validation.
Data Provenance: Not specified.

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 as no "test set" with ground truth established by experts is described for performance evaluation. The "ground truth" mentioned in the context of the device's function is the patient's dentition (3D models).

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

Not applicable. No expert adjudication process for a test set is described.

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 comparative effectiveness study was done or reported. The document focuses on the software as a tool for "orthodontic diagnosis and treatment simulation" and does not describe studies involving human readers or AI assistance in decision-making or improvement. The device itself performs calculations and simulations, not interpretation for a human reader to then act upon (though it informs the orthodontist).

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

The document describes the ULab Systems UDesign as "orthodontic diagnosis and treatment simulation software." Its purpose is to output treatment plans which may be used to fabricate dental casts. While the software itself performs calculations and simulations (a standalone algorithmic function), the "use of ULab Systems UDesign requires 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." This indicates that it's a tool for a trained professional, implying a human-in-the-loop process for clinical application, even if the core simulation is standalone. However, no specific "standalone performance study" in the sense of accuracy against a clinical outcome is described. The performance data section refers to "Software and integration verification and validation testing."

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

For the software functions, the "ground truth" would be the mathematical and logical correctness of its calculations and simulations based on the input 3D models of the patient's dentition. The document doesn't detail how this "ground truth" was established or used for the software validation, other than stating testing was performed. It's safe to assume it's based on known geometric principles and potentially clinical scenarios, but not explicitly stated as expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. The document describes software for design and simulation, not a machine learning or AI model that requires a "training set" of data in the typical sense. The "software and integration verification and validation testing" would be for the developed software code.

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

Not applicable, as there is no "training set" for an AI model mentioned.

Summary of what's provided:

The submission focuses on the regulatory clearance process for a medical device (software) based on:

Its intended use and indications for use.
Comparisons to a predicate device (3Shape Ortho System) showing substantial equivalence in technological characteristics.
General affirmance that "Software and integration verification and validation testing was performed" in accordance with FDA guidance, and "All test results met acceptance criteria."

The document does not delve into the clinical performance metrics of the software in real-world or simulated orthodontic treatment accuracy, nor does it describe AI-specific validation or clinical efficacy studies with expert review or patient outcomes. The "performance data" discussed is about software engineering validation, not clinical performance for treatment simulation or diagnosis accuracy.

Summary

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January 9, 2018

ULab Systems, Inc. Charlie Wen President & Chief Technology Officer 101 Jefferson Drive, Suite 212A Menlo Park, California 94025

Re: K171295

Trade/Device Name: Ulab Systems UDesign Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: November 27, 2017 Received: November 29, 2017

Dear Charlie Wen:

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.

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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 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K171295

Device Name

ULab Systems UDesign

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

I. Submitter Information
Submitter name:	ULab Systems, Inc.
	101 Jefferson Drive
	Suite 212A
	Menlo Park, CA 95025
Contact person:	Charlie Wen
	President & CTO of ULab Systems, Inc,
	Email: charlie@ulabsystems.com
	Phone : (650) 868-4935
Date Prepared:	27 November 2017
II. Product Classification
t	TY 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1TT

Device Name:	ULab Systems UDesign
Common Name:	Orthodontic Software
CFR Classification:	21 CRF 872.5470
Device Class:	II
Product Code:	PNN, LLZ

III. Predicate Device

Predicate: 3Shape Ortho System (K152086), 3Shape A/S

IV. Device Description

V. 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.

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VI. Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Device

The subject and the predicate devices share the same intended use as software used by dental professionals in orthodontic treatment planning for management of patients and orthodontic models; inspection, measurement and analysis of the models; treatment simulation; preparation and export of a series of virtual dental casts.

The subject and predicate device are based on the following same technological elements:

. Both are stand-alone software designed for use in management of 3D orthodontic models from patient scans;
Both may be used to design a series of dental casts;
Both apply digital imaging tools based on 3D orthodontic models for in orthodontic case archiving, diagnosis, treatment planning and CAD design;
. Both provide virtual planning of orthodontic treatments simulating tooth movements;
Both support stereolithography (STL file format).

Whereas the predicate device designs custom metal bands, indirect bonding transfer trays and dental casts, the subject device designs only dental casts. The predicate device additionally accepts inputs in multiple formats; the subject device only accepts STL file formats.

VII. Performance Data

Software and integration verification and validation testing was 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).

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 ULab Systems UDesign performs as intended, raises no new or different questions of risk and is substantially equivalent to the predicate device.

VIII. Conclusions

The ULab Systems UDesign has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the ULab Systems UDesign is substantially equivalent to the cleared 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.