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 dental casts, which may be used for sequential aligner trays or retainers, and of Indirect Bonding Transfer Media, based on 3D models of the patient's dentition before the start of an orthodontie treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the treatment to evaluate if the outcome is consistent with the planned desired treatment objectives. The use of ul ab 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.

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 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, and of indirect bonding transfer trays.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for the ULab Systems uDesign Software. This document focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with rigorous acceptance criteria typical for AI/ML devices that make new diagnostic claims or require clinical performance validation.

Based on the provided text, the device is a "medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of dental casts." It is not an AI/ML device making diagnostic or prognostic claims requiring clinical performance studies with acceptance criteria based on sensitivity, specificity, or AUC. Instead, it is a software device intended for use by dental professionals for orthodontic treatment planning and design, and its performance validation revolves around software verification and validation.

Therefore, the information regarding acceptance criteria and performance study details as requested (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) is not explicitly present in the provided document because the nature of the device and its regulatory pathway (510(k) for substantial equivalence of software tools) do not typically require such detailed clinical performance studies.

However, I will extract what information is available regarding performance and acceptance criteria and explicitly state where the requested information is not provided.

Device: ULab Systems uDesign Software

Regulatory Pathway: 510(k) Premarket Notification

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for software tools rather than a diagnostic AI/ML algorithm, the "acceptance criteria" discussed are related to software verification and validation, not clinical performance metrics like sensitivity or specificity.

Acceptance Criterion (Implicit from V&V)	Reported Device Performance
Software Functionality & Reliability	The document states: "All test results met acceptance criteria, demonstrating the uLab Systems uDesign performs as intended." This indicates successful functional testing, integration testing, and reliability testing.
Hazard Mitigation (Risk Management)	"The testing includes validation of implemented mitigations related to device hazards identified in the risk management procedures." This implies that the software adequately addresses identified risks, meeting the acceptance criteria for safety and risk controls.
Substantial Equivalence	"demonstrates that the device should perform as intended in the specified use conditions. Therefore, the ULab Systems UDesign is substantially equivalent to the cleared predicate devices." This is the ultimate regulatory acceptance criterion for a 510(k), confirming the device's technical characteristics and intended use are similar to a legally marketed predicate and do not raise new questions of safety or effectiveness.

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

The document does not specify the sample size for a test set in the context of clinical or performance data (e.g., number of patient cases or 3D models used for a performance evaluation). The testing mentioned is "Software and integration verification and validation testing." This typically involves testing scenarios, functions, and workflows, rather than a fixed "test set" of patient data in the same way an AI model would be evaluated.

Data provenance (e.g., country of origin, retrospective/prospective) is also not applicable or specified, as the evaluation is not a clinical study involving patient data collection for performance assessment.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. The "ground truth" for this type of software (an orthodontic design tool) is its ability to accurately execute its functions (e.g., allowing precise measurements, correct treatment simulation, proper STL file generation). This is validated through internal software testing, not typically through expert consensus on a dataset.

4. Adjudication Method for the Test Set

This information is not provided, as it's not relevant for software verification and validation testing of a design tool. Adjudication methods are typically used in clinical studies where expert readers resolve discrepancies in interpretations of medical images or data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

An MRMC study was not done. This type of study is typically conducted for diagnostic AI/ML devices to assess how the AI assists human readers in tasks like disease detection or diagnosis. The uDesign software is a tool for orthodontic planning and design, not an AI for assisting with diagnostic accuracy. Therefore, there is no effect size reported for how human readers improve with AI vs. without AI assistance.

6. If a Standalone Performance Study Was Done

A standalone performance study in the sense of an algorithm-only (without human-in-the-loop) diagnostic accuracy study was not performed. The "performance data" refers to the successful completion of software verification and validation tests. The device itself is described as "providing tools for management," indicating it is an assistive software tool for a user, not a standalone diagnostic AI.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its software V&V, would be the correct functional behavior of the software components. For example:

Correct Measurement: If the software calculates a distance, the ground truth is the mathematically correct distance for the virtual model.
Accurate Simulation: If it simulates tooth movement, the ground truth is that the simulation adheres to the programmed algorithms and orthodontic principles.
Correct File Generation: The ground truth for STL file output is that the generated file accurately represents the virtual design and is in the correct format.

This "ground truth" is established through software engineering best practices, including requirements traceability, design specifications, and automated/manual testing against these specifications. It is not based on clinical outcomes, pathology, or expert consensus on clinical cases.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The uLab Systems uDesign software is described as a "medical front-end device providing tools" and as "orthodontic diagnosis and treatment simulation software." The document does not indicate that it is an AI/ML device trained on a dataset. It appears to be a rule-based or algorithmic software tool rather than one developed through machine learning. Therefore, there is no "training set" in the context of AI/ML.

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

This information is not applicable, as there is no indication of a "training set" for an AI/ML algorithm.

Summary

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June 23, 2020

ULab Systems, Inc. % Sylvia Erickson Regulatory Consultant Sylvia Erickson Consulting 157 Ruby Avenue San Carlos, California 94070

Re: K200772

Trade/Device Name: ULab Systems uDesign Software Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: March 23, 2020 Received: March 25, 2020

Dear Sylvia Erickson:

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.

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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) 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 Srinivas "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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

K200772

Device Name uLab Systems uDesign Software

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (7/17)

Page 1 of 1

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510(k) Summary

This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant Information:

uLab Systems, Inc. 1820 Gateway Drive Suite 300 San Mateo, CA 94404

Contact Person: Charlie Wen Phone: 650-804-1397

Submission Correspondent:

Sylvia Erickson Principal, Sylvia Erickson Consulting

Device Information:

Trade Name:	uLab Systems uDesign Software
Common Name:	Orthodontic Software
Classification Name:	Orthodontic Plastic Bracket
Classification Regulation:	21CFR 872.5470
Device Class:	II
Product Code:	PNN, LLZ

Primary Predicate:

uLab Systems uDesign Software, K171295

Reference Device:

3Shape A/S Ortho System, K152086

Date Prepared:

June 23, 2020

Device Description:

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treatment needs of the patient and rapidly develop a treatment plan. 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, and of indirect bonding transfer trays.

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, and of Indirect Bonding Transfer Media, 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 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.

Substantial Equivalence Table				Differences
Attribute	Subject DeviceModified uLab SystemsuDesign with IDB SoftwareModule	Primary PredicateuLab Systems uDesign(K171295)	Reference Device3Shape A/S Ortho System(K152086)
Product Code	PNN, LLZ	PNN, LLZ	PNN, LLZ	None
Common Name	Orthodontic Software	Orthodontic Software	Orthodontic Software	None
Classification Name	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket	None
Regulation Number	21 CFR 872.5470	21 CFR 872.5470	21 CFR 872.5470	None
Intended Use	· Used by dentalprofessionals inorthodontic treatmentplanning (before, during,after treatment)· Management of patientsand models· Inspection, measurementand analysis oforthodontic models· Treatment simulation· Virtual appliancepreparation (includingdental casts), handlingand export· Provides digital file anddevice output	· Used by dentalprofessionals inorthodontic treatmentplanning (before, during,after treatment)· Management of patientsand models· Inspection, measurementand analysis oforthodontic models· Treatment simulation· Virtual dental castspreparation, handling andexport· Provides digital fileoutput	· Used by dentalprofessionals inorthodontic treatmentplanning (before, during,after treatment)· Management of patientsand models· Inspection, measurementand analysis oforthodontic models· Treatment simulation· Virtual appliancepreparation (includingdental casts), handlingand export· Provides digital file anddevice output	All 3 devices output STL files forfabrication of dental casts.The Subject Device andReference Device both additionallyoutput Indirect Bonding TransferMedia.
Indications for Use	The ULab SystemsUDesign is intended foruse as a medical front-enddevice providing tools formanagement oforthodontic models,	The ULab SystemsUDesign is intended for useas a medical front-enddevice providing tools formanagement of orthodonticmodels, systematic	3Shape Ortho System isintended for use as amedical front-end deviceproviding tools formanagement of orthodonticmodels, systematic	The indications for use for the 3devices are the same, with theexception of the virtual designoptions.Compared to the Primary Predicate,
	systematic inspection,	inspection, detailed	inspection, detailed analysis,	the Subject Device additionally is

Comparison of Intended Use and Technological Characteristics with the Predicate Device:

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	detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, and of Indirect Bonding Transfer Media, 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 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.	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 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.	treatment simulation and virtual appliance design options (Custom Metal Bands, Export of Models, Indirect Bonding Transfer Media) 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 Ortho System 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.	used for design of Indirect Bonding Transfer Media.The Subject Device virtual design options are a subset of the virtual design options for the Reference Device, which is additionally used for design of custom metal bands.
Intended User	Dental Professionals	Dental Professionals	Dental Professionals	None
Intended Patient Population	Patients with malocclusion	Patients with malocclusion	Not specified	The intended patient population for the subject and Primary Predicate is a subset of the intended patient population for the Reference Device, which is not defined.

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 devices are based on the following same technological elements:

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

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

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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.

Summary:

The uLab Systems uDesign has the same intended use as the predicate devices. In addition, it has similar technological characteristics; performance data demonstrates that the device should perform as intended in the specified use conditions. Therefore, the uLab Systems uDesign is substantially equivalent to the cleared 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.