The uLab Systems Dental Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Device Description

The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctorprescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed and customized by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position.

AI/ML Overview

I am sorry, but the provided text (K211510 FDA 510(k) Summary for uLab Systems Dental Aligner Kit) describes an orthodontic treatment system (aligners) and not a device that would typically have the kind of acceptance criteria, test set, ground truth, and human-in-the-loop performance studies as outlined in your request.

The document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through comparison of:

Intended Use: "alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces."
Technological Characteristics: clear plastic sequential aligners, principles of operation, aligner design process using dental software, materials (thermoplastic), and general features.

The "Performance Data" section (Page 6) briefly mentions that performance testing remains unchanged from the company's previous reference device submission (K192596) and includes:

Biocompatibility (ISO 10993-10)
Design verification and process validation testing
User validation testing
Packaging verification and shelf life testing
Physical properties testing by the material manufacturer

This type of information is typical for a 510(k) submission for a physical medical device like an aligner, which is considered a Class II device (Orthodontic Plastic Bracket, Product Code NXC). It does not involve an AI algorithm or software that performs diagnostic or imaging analysis requiring the specific types of studies (e.g., MRMC, standalone AI performance, expert adjudication of ground truth for AI model testing) that your detailed request outlines.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document is about a physical dental aligner product, not an AI/software device that analyzes data or images.

Summary

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February 24, 2022

uLab Systems, Inc. % Sylvia Erickson Principal Sylvia Erickson Consulting 157 Ruby Avenue San Carlos, California 94070

Re: K211510

Trade/Device Name: uLab Systems Dental Aligner Kit Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 27, 2022 Received: January 31, 2022

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.

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) 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 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) K211510

Device Name uLab Systems Dental Aligner Kit

Indications for Use (Describe)

The uLab Systems Dental Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K211510

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: Amir Abolfathi Phone: 650-804-1397

Submission Correspondent:

Sylvia Erickson Principal, Sylvia Erickson Consulting

Device Information:

Trade Name:	uLab Systems Dental Aligner Kit
Common Name:	Sequential Aligner
Classification Name:	Orthodontic Plastic Bracket
Classification Regulation:	21CFR 872.5470
Device Class:	II
Product Code:	NXC

Primary Predicate Device:

Smylio Invisible Clear Aligners (Smylio, Inc.), K212660

Reference Device:

uLab Systems Dental Aligner Kit (uLab Systems, Inc.), K192596

Date Prepared:

February 22, 2022

Device Description:

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Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position.

Indications for Use:

The uLab Systems Dental Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

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

The subject and predicate devices share the same intended use for alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

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

Both devices are clear plastic sequential aligners.
. Both devices have the same intended use for alignment of teeth during orthodontictreatment of malocclusions by way of continuous gentle forces.
. Both devices have the same principle of operation.
Both devices are fabricated based on an orthodontic treatment plan designed from digital scans of the patient's teeth in an untreated state.
For both devices, the treatment plan is approved by the prescribing physician prior to manufacturing.
Both devices are made of thermoplastic.
. Treatment with both devices are monitored by the patient's dental health professional from placement of the first aligner through the delivery of the final aligner.

The only differences between the subject and predicate devices are the following:

. The subject device may alternatively be fabricated based on an orthodontic treatment plan designed by a dental practitioner.
The subject device materials are the same materials as used in the reference device, whereas the predicate device materials are an unspecified thermoplastic.
. The indications for use for the subject device include the mode of action for correction of malocclusion: "by way of continuous gentle forces." The subject device does not include the words "permanent teeth" as compared to the reference device. However, this is in alignment with the Indications for Use for the primary predicate device.

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Attribute	Subject Device	Primary Predicate	Reference Device
	uLab Systems DentalAligner Kit (uLabSystems)	Smylio Invisible ClearAligners (Smylio, Inc.)K212660	uLab Systems DentalAligner Kit (uLabSystems) K192596
Indicationsfor Use	The uLab Systems DentalAligner is indicated forthe alignment of teethduring orthodontictreatment ofmalocclusions by way ofcontinuous gentle forces.	The Smylio Invisible ClearAligners are indicated forthe alignment of teethduring orthodontictreatment of malocclusion.	The uLab Systems DentalAligner is indicated for thealignment of permanentteeth during orthodontictreatment of malocclusionsby way of continuousgentle forces.
DeviceDescription	A series of customizedremovable clear plasticorthodontic aligners thatsequentially positionteeth by way ofcontinuous gentle force.	A series of customizedremovable clear plasticorthodontic aligners thatsequentially positionteeth by way ofcontinuous gentle force.	A series of customizedremovable clear plasticorthodontic aligners thatsequentially position teethby way of continuousgentle force.
Principles ofOperation	Each preformed plastictray is worn in sequenceby the patient asprescribed by the dentalpractitioner. Orthodonticmovement occurs throughcontinuous gentle forcesapplied to the dentition aseach tooth follows theprogrammeddisplacement based on adoctor's prescription.	Each preformed plastictray is worn in sequenceby the patient asprescribed by the dentalpractitioner.Orthodontic movementoccurs through continuousgentle forces applied tothe dentition as eachtooth follows theprogrammed displacementbased on a doctor'sprescription.	Each preformed plastictray is worn in sequence bythe patient as prescribedby the dental practitioner.Orthodontic movementoccurs through continuousgentle forces applied to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription.
AlignerDesignProcess	Standard dentalsoftware, including theuLab Systems uDesign,K171295, for toothalignment uses digitalscan (untreated state) togenerate the image of afinal, provisional treatedstate and then interpretsa series of images thatrepresent intermediateteeth states. The dentalpractitioner then reviewsthese images and has theoption to reject, make orrequest modifications tothe set-up prior toapproving it for alignerfabrication. Once thedental practitioner	Standard dental softwarefor tooth alignment usesdigital scan (untreatedstate) to generate theimage of a final,provisional treated stateand then interprets aseries of images thatrepresent intermediateteeth states. The dentalpractitioner then reviewsthese images and has theoption to reject orrequest modifications tothe set-up prior toapproving it for alignerfabrication. Once thedental practitionerapproves the treatmentplan, the software	Standard dental software,including the uLab SystemsuDesign, K171295, fortooth alignment usesdigital scan (untreatedstate) to generate theimage of a final,provisional treated stateand then interprets aseries of images thatrepresent intermediateteeth states. The dentalpractitioner then reviewsthese images and has theoption to reject, make orrequest modifications tothe set-up prior toapproving it for alignerfabrication. Once thedental practitioner
Attribute	Subject DeviceuLab Systems DentalAligner Kit (uLabSystems)	Primary PredicateSmylio Invisible ClearAligners (Smylio, Inc.)K212660	Reference DeviceuLab Systems DentalAligner Kit (uLabSystems) K192596
	plan, the softwareconverts the files toproduce the series of 3Dmodels used to producethermoformed aligners.	produce the series of 3Dmodels used to producethermoformed aligners.	plan, the software convertsthe files to produce theseries of 3D models usedto produce thermoformedaligners.
Material	Zendura A (thinthermoformedpolyurethane) or ZenduraFLX (copolyester andpolyurethane composite)	Thermoplastic	Zendura A (thinthermoformedpolyurethane) or ZenduraFLX (copolyester andpolyurethane composite)
Features	Aligners made fromdifferent materials asprescribed by physician	Aligners made fromdifferent materials asprescribed by physician fordaytime or nighttime use	Aligners made fromdifferent materials asprescribed by physician
OTC or Rx	Rx	Rx	Rx
Sterilization	No	No	No

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Performance Data:

The performance testing remains unchanged from the company's own reference device submission, K192596. The performance testing for the subject device is being leveraged from the company's own reference device including: biocompatibility (ISO 10993-10), design verification and process validation testing, user validation testing, packaging verification and shelf life testing, and physical properties testing by the material manufacturer.

Conclusion:

The uLab Systems Dental Aligner Kit has the similar Indications for Use as the predicate device and identical technological characteristics as the company's own reference device. Performance data demonstrates that any differences in technological characteristics between the primary predicate device and subject device do not raise different questions of safety or effectiveness or are supported by the reference predicate. Therefore, the uLab Systems Dental Aligner Kit 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.