The Clear Moves Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Clear Moves Aligners position teeth by way of continuous gentle force.

Device Description

The Clear Moves Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement of the teeth to the final desired position. The sequential aligners introduce increments that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning. Generally the typical wear time for each aligner is a two weeks duration prior to being replaced by the next aligner in sequence.

A digital or traditional mold impression of the patient's dentition is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data of the patient's dentition, a specialized orthodontic CAD/CAM software is used to develop treatment plan. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health profession's prescription.

The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.

Once approved. the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Space Maintainers Laboratories produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The trays are provided to the dental health care professional who provides them to the patients in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment of the first aligner is delivered to when the final aligner is finished and treatment is complete. The aligners are held in place by pressure and can be removed by the patient at any time.

AI/ML Overview

Based on the provided text, the device in question is the "Clear Moves Aligners," which is an orthodontic device. The FDA document K240038 is a 510(k) premarket notification, indicating that the manufacturer is seeking substantial equivalence to a legally marketed predicate device rather than outright approval based on a clinical efficacy study.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence to a predicate device, rather than a clinical trial demonstrating efficacy of the aligners themselves beyond what is already established for this class of device.

The document states multiple times that "there was no clinical testing necessary to support this device" due to the well-established clinical performance of sequential aligners and the device's equivalence to its predicate.

Here's an analysis of the provided information concerning the acceptance criteria for substantial equivalence and the "study" (non-clinical testing and comparison) proving this:

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

The "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a predicate device (K223141 STR8 Clear Aligners and another reference predicate). This means showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

Acceptance Criteria (based on Substantial Equivalence to Predicate)	Reported Device Performance (Clear Moves Aligners)	Outcome / Discussion
Intended Use & Indications for Use: Same as predicate. (Treatment of tooth malocclusion in patients with permanent dentition by way of continuous gentle force.)	"The Clear Moves Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Clear Moves Aligners position teeth by way of continuous gentle force."	Same: Slight wording difference deemed not to affect intended use/indications.
Regulation Number: 21 CFR 872.5470	21 CFR 872.5470	Same
Classifications: Class II	Class II	Same
Product Code: NXC	NXC	Same
Mode of Action: Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays.	"Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastics trays"	Same
Material: Zendura FLX (copolyester and polyurethane composite)	Zendura FLX (copolyester and polyurethane composite)	Same
Biocompatibility: Yes	Yes	Same: Demonstrated by using same material and manufacturing processes as predicate, and additional testing.
Software: FDA cleared for intended use (PNN product code)	Guidemia Ortho+ (K162850), FDA cleared under PNN.	Different but Equivalent: Different software, but both are FDA cleared for their intended use (PNN product code), thus not affecting substantial equivalence.
Software Design Process: Uses digital scan of impression, generates final state and intermediate states, dental practitioner approval, software converts files to produce aligners.	"The standard ortho dental software uses a scan of tooth impression or a digital scan to generate the image of a final, treated state and then interprets a series of images that represent intermediate teeth states. Once the dental practitioner approves the treatment plan, the software converts the files to produce the series of patient specific aligners."	Similar: Described as "Similar, does not affect substantial equivalence."
Manufacture Method: Thermoforming	Thermoforming	Same
Rx or OTC: Rx	Rx	Same
Sterility: Non-sterile	Non-sterile	Same
Design: Aligners	Aligners	Similar: Described as "Similar, does not affect substantial equivalence."
Manufacturing Dimensional Accuracy: Translational measurements within 0.150mm (150 microns) of target, and acceptable final aligner fit.	"Translational measurement were within 0.150mm (150microns) of the target input value, the predefined tolerance of the manufacturing process. The testing results are within the acceptance criteria to demonstrate dimensional accuracy. Additionally, the final aligner fitness evaluation by a trained physician demonstrate all the aligners including in the study passed and were deemed an excellent fit."	Met: Internal manufacturing validation confirmed.
Biocompatibility Testing: Material certified to ISO 10993 standards (Tests for in vitro cytotoxicity, Skin Irritation, Sensitization, Subacute/Subchronic Toxicity, Genotoxicity)	Material tested according to ISO 10993-1, 10993-5, 10993-10, 10993-11, 10993-3; additional cytotoxicity on final product.	Met: Extensive biocompatibility testing conducted on the material.
Physical Properties Testing: Tensile Strength, Elongation, Elastic Modulus, Flexural Strength	ASTM D638 and ASTM D790 tests conducted by material manufacturer.	Met: Physical properties of material tested.

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

Test Set (Non-Clinical Performance Data):
- Manufacturing Validation: The document states "An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing for Clear Moves Aligner." and "all the aligners including in the study passed and were deemed an excellent fit." However, it does not specify the sample size (number of aligners or manufacturing runs) used for this internal validation.
- Biocompatibility & Physical Properties: The data provenance for these tests is the "material manufacture." This implies the tests were conducted by the supplier of the Zendura FLX material, not SML. No country of origin is specified for these tests. These are presumably prospective tests performed on the material and (for cytotoxicity) the final product.
- Clinical Performance Data: The document explicitly states: "The clinical performance of sequential aligners (product code NXC) has been well established since the first device of this category was cleared by the FDA in 1998. The Clear Moves aligners have equivalent indication and method of use to its predicate, therefore there was no clinical testing necessary to support this device." Thus, there is no clinical "test set" in the context of a new human clinical study performed for this specific device.

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)

Manufacturing Validation: "A trained physician" evaluated the final aligner fitness. The exact number of physicians or their specific qualifications (e.g., years of experience) are not specified, beyond being "trained."
Other Data: Given that no new clinical study was conducted for this device, the concept of "experts establishing ground truth for a test set" involving human patients does not directly apply to this 510(k) submission's safety and effectiveness demonstration beyond the general scientific and regulatory consensus on the predicate.

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

Manufacturing Validation: The document mentions "a trained physician" evaluated the fit. It does not mention any adjudication method (e.g., multiple readers, consensus, etc.). If only one physician was involved, the adjudication method would implicitly be "none" in terms of multiple expert reviews.
Other Data: Not applicable as no multi-reader evaluation was performed for the device's performance given the nature of the submission.

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 Study: The document explicitly states "there was no clinical testing necessary to support this device." Therefore, no MRMC comparative effectiveness study was done.
No AI Assistance Element: This device (aligners) is a physical medical device, not an AI software intended to assist human readers (e.g., radiologists interpreting images). The software mentioned is for treatment planning, not for image interpretation by clinicians requiring AI assistance.

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

Manufacturing Validation: An "internal manufacturing validation" was done, assessing dimensional accuracy and fit. This is a standalone performance test of the manufacturing process and aligner product, but not an "algorithm" in the sense of AI.
Software: The Guidenia Ortho+ software is mentioned as FDA-cleared (K162850), implying it has its own standalone performance characteristics for the purpose of treatment planning, but this submission isn't validating that software itself, only confirming its cleared status.

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

Manufacturing Validation: The "ground truth" for the manufacturing validation implicitly involved predefined engineering tolerances (0.150mm) for dimensional accuracy and a trained physician's assessment of "excellent fit" as an acceptance criterion.
Substantial Equivalence: The primary "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate device (STR8 Clear Aligners, K223141) and the established clinical practice for sequential aligners in general.

8. The sample size for the training set

No new training set data: Since no new clinical study was performed for this 510(k), there is no "training set" of patient data in the typical sense of an efficacy trial.
Manufacturing Process/Software: The software used (Guidemia Ortho+) and the manufacturing processes would have their own internal validation/training data, but these details are not provided in this 510(k) summary as SML is not validating the software itself, only using a cleared one, and the manufacturing process details are proprietary.

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

Not applicable for this 510(k) context: As explained above, no new clinical training set was established. The ground truth for the predicate device's initial clearance and the general understanding of orthodontic aligners is based on historical clinical data and expert consensus over many years in the field of dentistry and orthodontics.

Summary

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April 4, 2024

Space Maintainers Laboratories (SML) % Na Zhang Consultant/Project Manager DeviceMC LLC. 1 Bav Street Rancho Mission Viejo, California 92694

Re: K240038

Trade/Device Name: Clear Moves Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 3, 2024 Received: January 5, 2024

Dear Na Zhang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices

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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

Submission Number (if known)

K240038

Device Name

Clear Moves Aligners

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

SUBMITTER

Date Prepared:	April 1, 2024
Submitter:	Space Maintainers Laboratories(SML)
	5922 9129 Lurline Ave
	Chatsworth, CA 91311-5922
	United States of America
Official Contact:	Scott Veis
	COO
	TEL:800-423-3270
	Email: scottv@smlglobal.com

DEVICE

Trade/Proprietary Name:	Clear Moves Aligners
Common Name:	Aligners, Sequential
Classification Name :	Orthodontic Plastic Bracket
Classification Regulations:	21CFR 872.5470
Product Code:	NXC
Device Classification:	Class II
Classification Panel:	Dental Products Panel
Reviewing Branch	Dental Devices Branch

PRIDICATE DEVICE

Primary Predicate Device: K223141 STR8 Clear Aligners STR8 Oral Care

DEVICE DESCRIPTION

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corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health profession's prescription.

The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL WITH THE PREDICATE DEVICE

The subject device is substantial equivalent in intended use and technological characteristics to predicate devices mentioned above. Below is a summary table comparing the subjective device with the primary predicate and an additional reference predicate device.

Features	Submission Device	Predicate Device	SubstantialEquivalentComparison
Manufacture	Space MaintainersLaboratories (SML)	STR8 Oral Care	N/A
Trade Name	Clear MovesAligners	STR8 Clear Aligners	N/A
510(k)Number	N/A	K223141	N/A
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470	Same
Classifications	Class II	Class II	Same
Product Code	NXC	NXC	Same
Indications forUse	The Clear MovesAligners areindicated for the	The STR Clear Aligner isindicated for the Alignmentof teeth during orthodontic	Same, slightdifference inwording will
	treatment of toothmalocclusion inpatients withpermanent dentition(i.e., all secondmolars). The ClearMoves Alignersposition teeth by wayof continuous gentleforce.	treatment of malocclusionsby way of continuous gentleforces	not affect theintendeduse/indicationsfor use
Mode ofActions	Alignment of teethby application ofcontinuous gentleforce, by sequentialuse of preformedplastics trays	Each performed Plastic trayis worn in sequence by thepatient as prescribed by thedental practitioner.Orthodontic movementoccurs through continuousgentle forces applied to thedentition as each toothfollows the programmeddisplacement based on thedoctor's prescription	Same
Material	Zendura FLX(copolyester and polyurethane composite)	Zendura FLX (copolyesterand poly urethanecomposite)	Same
Biocompatible	Yes	Yes	Same
Software	Guidemia Ortho+(K162850)	Treatment Planning System(K213916)	Different, doesnot affectsubstantialequivalence
SoftwareDesignProcess	The standard orthodental software usesa scan of toothimpression or adigital scan togenerate the image ofa final, treated stateand then interprets aseries of images thatrepresentintermediate teethstates. Once thedental practitionerapproves thetreatment plan, thesoftware converts the	Standard dental softwarefor tooth alignment usesdigital scan(untreated state)to generate the image of afinal provisional treatedstate and then interprets aseries of images thatrepresent intermediate teethstates. The dentalpractitioner then reviewthese images and has optionto reject or requestmodifications to the set-upprior to approving foraligner fabrication. Oncethe dental practitioner	Similar, doesnot affectsubstantialequivalence
	files to produce theseries of patientspecific aligners.	approves the treatment plan,the software converts thefiles to produce a series 3 Dmodels used to produce
ManufactureMethod	Thermoforming	thermoformed alignersThermoforming	Same
Rx or OTC	Rx	Rx	Same
Sterility	Non-sterile	Non-sterile	Same
Design	Image: aligners	Image: aligners	Similar, doesnot affectsubstantialequivalence

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Substantial Equivalence Discussion:

The indications of use of the Clear Moves aligners is same as the predicate device. Slight difference in wording will not affect the intended use of the devices as they are both intended for correcting dental malocclusion patients with permanent dentition.

The subjective has very similar technological characteristics as to the predicate device in material, principle of operation, manufacturing process, design and clinical application. The only difference compared to Clear Moves Aligner with the predicate device is the software used to treatment planning and creation of models/mold. However both software are FDA cleared, under product code PNN for its intended use, which will not affect substantial equivalence of safety and effectiveness.

Therefore, the Clear Moves Aligner is considered to be substantially equivalent to the predicate device based on a comparison of intended use and technological characteristics.

Non-Clinical PERFORMANCE DATA

Non-clinical testing have been conducted to verify that the Clear Moves Aligner meets all design specification which supports the conclusion that it's substantially equivalent (SE) to the predicate device.

Software used for treatment planning and creation of models/mold for Clear Moves Aligner is Guiemia Ortho + manufactured by Guidemia Technologies. LLC. It is a 510(K) clearance (K162850) software under product code PNN for intended use.

An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing for Clear Moves Aligner. The critical aspects of the manufacturing process were assessed for accuracy. The final aligner fitness was evaluated according to the in-house fitness acceptance criteria.

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Translational measurement were within 0.150mm (150microns) of the target input value, the predefined tolerance of the manufacturing process. The testing results are within the acceptance criteria to demonstrate dimensional accuracy. Additionally, the final aligner fitness evaluation by a trained physician demonstrate all the aligners including in the study passed and were deemed an excellent fit .

The biocompatibility evaluation determined that Clear Moves Aligner and the predicate devices are composed of the same material, fabricated by the similar manufacturing processes, and has identical method of use, which can conclude that Clear Moves Aligners are biocompatible for its intended use.

Biocompatibility testing for the aligner material, the only patient contacting material, was conducted by the material manufacture in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

• Test for in vitro cytotoxicity : Elution Method	ISO10993-5
• Skin Irritation Test in New Zealand White Rabbits	ISO10993-10
• Sensitization Test in Guinea Pigs	ISO10993-10

Sensitization Test in Guinea Pigs ●
Subacute/Subchronic Toxicity Testing . ISO 10993-11 Genotoxicity . ISO 10993-3

Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on the final manufactured Clear Moves Aligner .

Test for in vitro cytotoxicity : Minimal Essential Media (MEM) Elution ISO10993-5
Non-Clinical physical properties of the device material have been tested by the material manufacture complying with the following standard
Tensile Strength at Break(MPa) ASTM D638
Tensile Stress at Yield (MPa) ASTM D638
Elongation at Break (%) ASTM D638
Elongation at Yield (%) ● ASTM D638
Elastic Modulus (MPa) ASTM D638
Flexural Strength ASTM D790
Flexural Elastic Modulus ASTM D790 ●

CLINICAL PERFORMANCE DATA

The clinical performance of sequential aligners (product code NXC) has been well established since the first device of this category was cleared by the FDA in 1998. The Clear Moves aligners have equivalent indication and method of use to its predicate, therefore there was no clinical testing necessary to support this device.

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CONCLUSIONS

The subject device has very similar technological characteristics (i.e. design, function, principle of operation, materials, biocompatibility and sterilization) to the predicate device . The intended use and indications for use of the subject device are the same as the predicate device.

In conclusions, the subject device is substantially equivalent based on a comparison of intended use, and technological characteristics. Therefore, the device is considered to be safe and effective for its intended use.

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.