The U-Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The U-aligner system repositions teeth by way of continuous gentle force.

Device Description

The U-Aligner system is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.

A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the U-Aligner system based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth and completes a prescription form. Universal Orthodontic Lab then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment (Ortho System™, K180941). The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Universal Orthodontic Lab produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

The technology is essentially identical to that used by a number of sequential aligner systems, including the two predicate devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "U-Aligner." This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria through a standalone study. The document primarily focuses on comparing the U-Aligner's characteristics (indications for use, materials, mode of action) to those of predicate devices.

Therefore, the requested information regarding detailed acceptance criteria, a specific study proving the device meets them, sample sizes for test/training sets, expert qualifications, and adjudication methods for a medical image analysis or diagnostic device is not applicable to this document.

Here's why and what information can be extracted or inferred:

Type of Device: The U-Aligner is an orthodontic plastic bracket (sequential aligner), not an AI/ML-driven diagnostic or image analysis device. Its "performance" is largely related to its physical properties, manufacturing accuracy, and biocompatibility, not its ability to interpret data or make classifications.
Purpose of Submission: A 510(k) is about demonstrating "substantial equivalence" to a predicate device, meaning it is as safe and effective as a device already on the market. It's not typically about establishing entirely new performance benchmarks through de novo clinical trials.

Information that is relevant or can be inferred from the document:

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

Acceptance Criteria Category	Reference/Performance
Indications for Use (Substantial Equivalence)	U-Aligner: Treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). Repositions teeth by way of continuous gentle force.Predicate Devices: Have substantially equivalent indications for use. (Demonstrated by direct comparison table in the 510(k) summary)
Product Code (Substantial Equivalence)	NXC - All compared devices (U-Aligner, Primary Predicate K173785, Reference Device K113618) share the same product code.
Device Class (Substantial Equivalence)	Class II - All compared devices are Class II.
Mode of Action (Substantial Equivalence)	Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays. - Identical across U-Aligner and predicate devices.
Method of Use (Substantial Equivalence)	Each preformed plastic tray is worn by the patient as prescribed by the dental practitioner, usually a few weeks prior to using the next sequential aligner tray. - Identical across U-Aligner and predicate devices.
Material (Substantial Equivalence)	Thermoformed polyurethane. - Identical across U-Aligner and predicate devices.
Manufacturing Validation (Accuracy)	An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for U-Aligners. Results: The pre-planned location and position of tooth structures defined by the aligner is expected compared to the final finished thermoformed aligner.
Biocompatibility (Safety)	Tests: Cytotoxicity, Sensitization, Irritation (in accordance with ISO 10993-1).Results: Material is considered non-cytotoxic, non-sensitizing, and not an intracutaneous irritant. Met study protocol requirements.

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 typical test set definitions. This device is a physical orthodontic aligner.
For the manufacturing validation, the sample size is not stated, nor is the provenance of the data points (which would likely be internal manufacturing measurements).
For biocompatibility testing, the "sample size" would refer to the number of biological samples or subjects used in the in-vitro and in-vivo tests, which is not specified but implicitly met the requirements of ISO 10993-1.

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. There is no "ground truth" establishment in the context of image analysis or diagnostic performance as this is a physical device. The "truth" for biocompatibility is whether the material is toxic, sensitizing, or irritating, as measured by established biological tests. The "truth" for manufacturing accuracy is whether the physical output matches the digital design.

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

Not applicable. No adjudication on diagnostic findings is relevant here.

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:

Not applicable. This is not an AI-assisted diagnostic or imaging device, so such a study would not be performed. The device itself is the treatment tool.

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

Not applicable. This refers to AI algorithm performance. The U-Aligner is a physical device.

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

For biocompatibility: Established laboratory testing protocols (e.g., ISO 10993-1 standards for cytotoxicity, sensitization, irritation).
For manufacturing accuracy: Comparison of the physical aligner's dimensions to the digital design specifications (expected locations and positions of tooth structures).

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of AI/ML or a clinical study. The "design" phase involves dental software (Ortho System™, K180941), which itself would have been validated, but the specifics of its training data are not part of this 510(k).

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

Not applicable. As above, no training set for the U-Aligner device itself.
The "ground truth" for the overall process would be the desired tooth movement prescribed by a licensed dental professional (orthodontist or dentist), based on their assessment of the patient's teeth. The software then generates a series of aligners to achieve this target.

Summary

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April 23, 2020

Universal Orthodontic Laboratory Inc Jiahe Li Regulatory Affair Associate 11917 Front St. Norwalk, California 90650

Re: K191308

Trade/Device Name: U-Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: April 21, 2020 Received: April 21, 2020

Dear Jiahe Li:

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,

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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Section IV

Indications for Use Statement

510(k) Number (if known): K191308

Device Name: _ U-Aligner

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR

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K191308 Section V

510(k) Summary

Submitter:

Universal Orthodontic Lab 11917 Front St. Norwalk, CA 90650 Contact Person: Jiahe Li Requlatory Affairs Manager Lijh0919@gmail.com (562) 484-0500

Date Summary Prepared:

May 1st, 2019

DEVICE NAME

TRADE NAME: U-Aligner

COMMON NAME: Sequential Aligner

DEVICE CLASSIFICATION: Aligner, Sequential

CLASSIFICATION PRODUCT CODE: NXC

PREDICATE DEVICE

Primary Predicate - Custom Clear Aligner System - Derby Dental Laboratory - K173785 Reference Device - ClearCorrect System- ClearCorrect LLC - K113618

DESCRIPTION OF DEVICE

The U-Aligner system is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth

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malocclusions without the use of conventional wire and bracket orthodontic technology.

The technology is essentially identical to that used by a number of sequential aligner systems, including the two predicate devices.

INDICATIONS FOR USE

The U-Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner system repositions teeth by way of continuous gentle force.

	U-Aligner	Primary Predicate-Custom ClearAligner System(K173785)	Reference Device-ClearCorrectSystem (K113618)	Substantialequivalence
ProductCode	NXC	NXC	NXC	Yes
Device Class	Class II	Class II	Class II	Yes
Intended Use	U-Aligner isindicated for thetreatment ofanterior toothmalocclusions inpatients withpermanent dentition(i.e. all second	The Custom ClearAligner System isindicated for use inthe alignment ofpermanent teeththrough orthodontictreatment ofmisalignment and	ClearCorrectSystem is indicatedfor the treatment ofanterior toothmalocclusions inpatients withpermanent dentition(i.e. all second	Yes

Summary of Technical Characteristics

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	molars).	malocclusion	molars).
Indicationsfor Use	The U-AlignerSystem is indicatedfor the treatment oftooth malocclusionin patients withpermanent dentition(i.e. all secondmolars). The U-aligner systemrepositions teeth byway of continuousgentle force.	The Custom ClearAligner System is aseries of clear,lightweight, plasticappliances indicatedfor thetreatment of toothmalocclusions inpatients withpermanent dentition(i.e., all secondmolars).Utilizing a series ofincremental toothmovements, itsequentiallypositions teeth byway of continuousgentle force.	ClearCorrectSystem is indicatedfor the treatment ofanterior toothmalocclusions inpatients withpermanent dentition(i.e. all secondmolars). The ClearCorrect Systempositions teeth byway of continuousgentle force.	Yes
Mode ofAction	Alignment of teethby application ofcontinuous gentleforce, bysequential use ofpreformed plastictrays	Alignment of teethby application ofcontinuous gentleforce, by sequentialuse of preformedplastic trays	Alignment of teethby application ofcontinuous gentleforce, bysequential use ofpreformed plastictrays	Yes
Method ofUse	Each preformedplastic tray is wornby the patient asprescribed by thedental practitioner,usually a fewweeks prior tousing the nextsequential alignertray	Each preformedplastic tray is wornby the patient asprescribed by thedental practitioner,usually a fewweeks prior tousing the nextsequential alignertray	Each preformedplastic tray is wornby the patient asprescribed by thedental practitioner,usually a fewweeks prior tousing the nextsequential alignertray	Yes
Material	Thermoformedpolyurethane	Thermoformedpolyurethane	Thermoformedpolyurethane	Yes

Performance Testing

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. The physical properties have been provided by the material manufacturer.

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An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for U-Aligners. The results show that the pre-planned location and position of tooth structures defined by the aligner is expected compared to the final finished thermoformed aligner.

Biocompatibility Testing

The biocompatibility evaluation for the device was conducted in accordance with ISO 10993-1, Biological evaluation and testing within a risk management process -Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA. The aligner is considered mucosal membrane contacting for a duration of greater than 30 days. The battery of testing included the following tests:

Cytotoxicity
Sensitization
Irritation

The results of the testing met the requirements of the study protocols and the material is considered non-cytotoxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence.

Conclusion

U-Aligner is considered to be substantially equivalent to the identified legally marketed predicate in terms of indications for use, design, technological characteristics, mode of action, performance, materials and biocompatibility.

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.