Smart Moves Complete is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Smart Moves Complete positions teeth by way of continuous gentle force.

Device Description

Smart Moves Complete consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners). The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. Smart Moves Complete is intended as an alternative to conventional bracket technology and fixed appliances for the treatment of patients with malocclusion.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Smart Moves Complete," an orthodontic aligner system. It details the device's indications for use, design, manufacturing, and comparison to a legally marketed predicate device. The submission explicitly states that no clinical studies were performed to support the device as the indications for use are equivalent to the predicate device, and thus, no comparative effectiveness study (such as MRMC) was done, nor was there a standalone algorithm performance evaluation.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, specifically within the context of AI/algorithm performance evaluation, cannot be extracted from this document as it pertains to a medical device that does not incorporate AI and relies on equivalence to a predicate device through non-clinical performance data.

The relevant sections of the document state:

"No clinical studies are included in the submission" (page 4)
"Clinical Performance Data: There was no clinical testing performed to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence is supported by non-clinical testing and the comparative table, so this is not required." (page 9)

Given this, I cannot provide the detailed information requested about acceptance criteria and a study proving the device meets them, as it relates to AI/algorithm performance, because such a study was not conducted or presented in this 510(k) submission.

The document focuses on demonstrating substantial equivalence based on:

Same intended use as the predicate device.
Similar technological characteristics, with a detailed comparison table (pages 5-6) highlighting similarities in product code, regulation number, regulation name, indications for use, device description, mode of action, anatomy location, size, manufacturing method, biocompatibility, hardness, and dental tooth alignment software description.
Non-clinical performance testing (page 8-9) for materials and manufacturing process, including biocompatibility, software verification and validation (though this refers to the design software for aligners, not an AI algorithm for diagnostic or treatment planning), tensile strength, elongation, tensile stress, modulus, load, water absorption, durometer, and process flow validation. These tests are about the physical properties and manufacturing consistency of the aligners, not AI performance.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Great Lakes Orthodontics Ltd Mr. David Graver Director of Logistics 200 Cooper Ave Tonawanda, New York 14150

Re: K172765

Trade/Device Name: Smart Moves Complete Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: April 30, 2018 Received: May 2, 2018

Dear David Graver:

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.

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.

June1, 2018

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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 medical devices and radiation-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

510(k) Number (if known) K172765

Device Name Smart Moves Complete

Indications for Use (Describe)

Smart Moves Complete is indicated for the treatment of tooth malocclusion in patients with permanent dentition (1.e. all second molars). Smart Moves Complete positions teeth by way of continuous gentle force.

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

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

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510(k) Summary

Smart Moves Complete

K172675

Sponsor

Great Lakes Orthodontics Ltd

200 Cooper Ave.

Tonawanda, NY 14150

Contact person:

Dave Graver

Director of Logistics

Date Prepared: May 31, 2018

Device Identification

Trade/Proprietary name: Smart Moves Complete Regulation Number: 21CFR 872.5470 Regulation Name: Aligner Sequential/ Orthodontic Plastic Bracket

Panel: Dental

Product Class: II

Product Code: NXC

Legally Marketed Predicate Device

K113618, ClearCorrect System, ClearCorrect Inc.

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Indications for Use

Background

Orthodontic treatment is conventionally performed using brackets and archwires. A bracket is bonded to each tooth and a wire is inserted with the goal of moving each tooth to a desired final treatment position. An alternative to traditional bracket treatment has been in existence for the past 20 years. This alternative treatment uses clear plastic aligners to gradually move the teeth. The aligners are designed in a series of incremental stages. A patient wears each aligner stage for a period of two weeks to accomplish the programmed tooth movement. Once tooth movement has been accomplished for a given stage the current aligner is removed and the next aligner in the sequence is worn. This method of orthodontic treatment is popular with patients because it provides a virtually invisible appliance and avoids the appearance of braces on the teeth.

Design and Use

This is a prescription use device by order of a Dentist or Orthodontist ●
Designed for single patient use (2 weeks/aligner)
Aligners are worn except for eating and brushing teeth. They are removed by the patient for those tasks.
It is not provide sterile
It does not contain any drugs or biologic
Software as part of the system is used by the Dental lab to design the aligners that the ● Dental professional reviews and approves prior to fabrication.
No clinical studies are included in the submission

Device Description

Aligner System

A dental health professional (e.g. orthodontist or dentist) prescribes Smart Moves Complete based on an assessment of the patient's teeth, takes molds of the patient's teeth, determines a course of treatment to reposition the teeth via gentle, corrective forces in the upper and lower dental arch, and completes a prescription form. Digital information concerning the patient's teeth and the prescription form are then sent electronically to Great Lakes Orthodontics.

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Great Lakes then designs a series of plastic thermoformed aligners in a sequential series intended to gradually realign the patient's teeth in accordance with the physician's prescription using standard dental tooth alignment software. The prescribing physician accesses the doctor-facing portion of the standard dental tooth alignment software to review and approve the model scheme before the thermoformed aligners are produced. Once approved, Great Lakes Orthodontics produces these aligners, which are formed of clear, thin, thermoformed plastic.

The aligners in a sequential series are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period of time, each progression of aligners 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 aligners are held in place by pressure and can be removed by the patient at any time.

Manufacturer	Great LakesOrthodontics, Ltd.	ClearCorrect Inc.	Device Comparison
Trade Name	Smart Moves Complete	ClearCorrect System	N/A
510(k) Number	K172765	K113618	N/A
Product Code	NXC	NXC	Same
Regulation Number	872.5470	872.5470	Same
Regulation Name	Orthodontic PlasticBracket	Orthodontic PlasticBracket	Same
Indications for UseStatement	Smart Moves Complete isindicated for thetreatment of toothmalocclusion in patientswith permanentdentition (i.e. all secondmolars). Smart MovesComplete positions teethby way of continuousgentle force.	The ClearCorrect Systemis indicated for thetreatment of toothmalocclusion in patientswith permanentdentition (i.e. all secondmolars). TheClearCorrect Systempositions teeth by way ofcontinuous gentle force.	Same
Device Description	Smart Moves Completeconsists of a series ofdoctor-prescribed, thin,clear plastic removableorthodontic appliances(aligners). The alignersgently move the patient'steeth in small incrementsfrom their original stateto a more optimal,treated state. SmartMoves Complete isintended as analternative to	The ClearCorrect deviceis fabricated of clear thinthermoformedpolyurethane plastic in asequential series toprogressively repositionthe teeth. Correctiveforce to straighten theteeth is delivered viaminor changes into aposition in eachsubsequent aligner.	Same; the deviceperforms treatment oftooth malocclusions inthe same way bycontinuous gentle force.

	conventional brackettechnology and fixedappliances for thetreatment of patientswith malocclusion.
Mode of Action	Orthodontic toothmovement occursthrough forces applied bythe appliance to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription.	Orthodontic toothmovement occursthrough forces applied bythe appliance to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription.	Same
Anatomy Location	Mouth; mucosalmembranes	Mouth; mucosalmembranes	Same
Size	Patient specific	Patient specific	Same
Manufacturing Method	Thermoforming	Thermoforming	Same
Material	0.03" ThermoplasticPETG	0.03" ThermoplasticPolyurethane	Similar; these are boththermoplastic formingmaterials that have samedurometer, similarproperties in modulusthat do not raise anyadditional questions ofsafety or efficacy.
Biocompatibility	Passed ISO 10993-1 andseries	Passed ISO 10993-1 andseries	Same
Hardness Durometer	$80 \pm 3$ Shore D	$80 \pm 3$ Shore D	Same
Material TensileStrength/Stress	Strength and stress ofmaterial tensileproduced acceptableresults for base material	Information not available	Base materials ofthermoplastic used tofabricate aligners usessimilar material used inthese applications gentletooth alignment. Thematerials arethermoformed plasticsthat are similar incomposition to thepredicate device notraising any additionalquestions of safety orefficacy.
Material Elongation	Elongation at yield andbreak producedacceptable results forbase material	Information not available	Base materials ofthermoplastic used tofabricate aligners usessimilar material used inthese applications gentletooth alignment. Thematerials arethermoformed plasticsthat are similar incomposition to thepredicate device notraising any additional

Material Modulus	Modulus resultsproduced similar resultsfor testing of basematerial	Information not available	Base materials ofthermoplastic used tofabricate aligners usessimilar material used inthese applications gentletooth alignment. Thematerials arethermoformed plasticsthat are similar incomposition to thepredicate device notraising any additionalquestions of safety orefficacy.
Material Load	Load at yield and breakproduced acceptableresults for base material	Information not available	Base materials ofthermoplastic used tofabricate aligners usessimilar material used inthese applications gentletooth alignment. Thematerials arethermoformed plasticsthat are similar incomposition to thepredicate device notraising any additionalquestions of safety orefficacy.
Dental Tooth AlignmentSoftware Description	The Smart MovesComplete 3-D softwareuses a scan of a PVSimpression or a digitalscan to generate theimage of a final, treatedstate and then interpretsa series of images thatrepresent intermediateteeth states. Once thedental practitionerapproves the treatmentplan, the softwareconverts the files toproduce the series ofpatient specific aligners.	The standard dentaltooth alignment softwareuses a scan of toothimpression or a digitalscan to generate theimage of a final, treatedstate and then interpretsa series of images thatrepresent intermediateteeth states. Once thedental practitionerapproves the treatmentplan, the softwareconverts the files toproduce the series ofpatient specific aligners.	Same
Healthcare ProfessionalReview	The dental practitionerreviews final alignerseries prior to fabricationand has the option toreject or requestmodifications to the set-up prior to approving itfor aligner fabrication.	The dental practitionerreviews final alignerseries prior to fabricationand has the option toreject or requestmodifications to the set-up prior to approving itfor aligner fabrication.	Same

Predicate Device Comparison

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Non-Clinical Performance Testing

As part of demonstrating safety and effectiveness of Smart Moves Complete and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Great Lakes Orthodontics completed a number of non-clinical performance tests. The Smart Moves Complete meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device.

The Smart Moves Complete passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

Biocompatibility testing per ISO 10993-1 passed cytotoxicity, sensitization, and irritation .
Software verification and validation testing using FDA's guidance document confirmed . acceptance to required specifications
There is no defined specification or standard for tensile strength so a sample of base . materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile strength yield
. There is no defined specification or standard for aligner elongation which a sample of based materials used for fabrication of aligners were tested and analyzed showing acceptable results in comparison of break point
. There is no defined specification or standard for tensile stress so a sample of base materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile stress at break point
. There is no defined specification or standard for modulus so this was tested for the base materials used for fabrication of aligners to show acceptable results between the samples tested
There is no defined specification or standard for load of materials which found acceptable ● results when tested and analyzed for samples of base material tested used for fabrication of aligners
There is no defined specification or standard for water absorption which found acceptable ● results when tested and analyzed for fabricated aligners
Durometer testing of thermoplastic forming material 80 ± 3 Shore D: Acceptable .

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Process Flow validation was performed to ensure that the finished device matches the software output specifications. The output and work model and aligner were tested and compared. Aligners met the specifications of this testing.

Clinical Performance Data

There was no clinical testing performed to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence is supported by non-clinical testing and the comparative table, so this is not required.

Substantial Equivalence Conclusion

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Based on the comparison and analysis above, the Smart Moves Complete is determined to be substantially equivalent to the referenced predicate device(s).

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.