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

Device Description

The Redline Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20-22 hours a day for an average of 2 weeks per aligner or as directed by the clinician and are to be removed only for eating and for cleaning.

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. 3Shape A/S Ortho System 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 3Shape A/S Ortho System, is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Johns dental 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

The provided document is a 510(k) Premarket Notification from the FDA for the Redline Aligner. It primarily demonstrates substantial equivalence to a predicate device rather than presenting a standalone study showing device performance against specific acceptance criteria in the manner one might expect for an AI/ML medical device.

Therefore, it is not possible to fully answer all aspects of your request as the document does not contain information about a study that "proves the device meets the acceptance criteria" in the context of an AI/ML device. The document focuses on showing the Redline Aligner's equivalence to existing devices based on design, materials, and manufacturing processes, rather than on its performance in a clinical trial or a specific AI-driven task.

However, I can extract the information that is present and indicate what is missing:

Description of Acceptance Criteria and Device Performance (Based on provided document)

The document describes non-clinical testing for the Redline Aligner, focusing on manufacturing accuracy and material properties, rather than clinical performance data against specific outcomes.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Manufacturing Dimensional Accuracy:	Translational measurement: Within 0.150mm (150 microns) of the target input value. There were no statistical differences in measured values among groups, indicating results were within the predefined tolerance.
Final Aligner Fitness:	All aligners included in the study passed and were deemed an excellent fit.
Biocompatibility:	Redline Aligners were concluded to be biocompatible for their intended use. Material testing was performed according to ISO 10993-1. Additional cytotoxicity testing was performed on final manufactured aligners according to ISO 10993-5:2009.

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

Sample Size for Test Set: Not explicitly stated as a numerical value. The document mentions an "internal manufacturing validation" where "The final aligner fitness was evaluated according to the in-house fitness acceptance criteria," and "all the aligners including in the study passed." A specific number of aligners tested is not provided.
Data Provenance: The testing was "internal manufacturing validation," implying it was conducted by Johns Dental Laboratories. The country of origin of this internal data is not specified, but the applicant (Johns Dental Laboratories) is based in Terre Haute, Indiana, United States. It is a retrospective evaluation of manufacturing output.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The "in-house fitness acceptance criteria" would likely be based on internal quality control standards established by qualified personnel, but the roles and qualifications are not detailed.

4. Adjudication Method for the Test Set:

Adjudication Method: Not specified. The document only states that "all the aligners including in the study passed and were deemed an excellent fit," suggesting a straightforward pass/fail assessment against defined criteria rather than a multi-reader adjudication process typically associated with AI/ML ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with/without AI Assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not done. The Redline Aligner is a physical medical device (orthodontic plastic bracket) and not an AI/ML algorithm that assists human readers.
Effect Size: Not applicable.

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

Standalone Performance: No, a standalone performance study for an algorithm was not done. The "3Shape A/S Ortho System" software is mentioned as being used "to develop treatment plan" and "to generate standard format 3D files," but this software's performance as a standalone AI/ML device is not evaluated here. The 510(k) is for the physical aligner.

7. The Type of Ground Truth Used:

Ground Truth: For dimensional accuracy, the "target input value" from the digital treatment plan served as the reference. For aligner fitness, "in-house fitness acceptance criteria" were used as the standard. For biocompatibility, international standards (ISO 10993-1, ISO 10993-5:2009) were the ground truth for material safety.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. The Redline Aligner is a manufactured physical device, not an AI/ML algorithm that requires a training set. The 3Shape A/S Ortho System is external software, and its training set information is not provided nor relevant to the Redline Aligner's 510(k).

9. How the Ground Truth for the Training Set was Established:

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for the physical device.

Summary

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February 9, 2022

Johns Dental Laboratories % Na Zhang Project Manager Evo820, LLC 1 Bay Street Rancho Mission Viejo, California 92694

Re: K213297

Trade/Device Name: Redline Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 19, 2022 Received: January 20, 2022

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 (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.

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) K213297

Device Name Redline Aligner

Indications for Use (Describe)

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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K213297 510(k) Summary

SUBMITTER

Date Prepared:	02/08/2022
Submitter:	Johns Dental Laboratories
	423 S.13th STTerre Haute, Indiana, 47807United States of America
Official Contact:	Mani BuisControllerTel:800-457-0504Fax:812-234-4464Email: marnih@johnsdental.com

DEVICE

Trade/Proprietary Name:	Redline
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

Predicate Device:	K172765	Smart Moves Complete	Great Lakes Orthodontics Ltd
Reference Device:	K191838	ClearForm Aligners	Motor City Lab Works

DEVICE DESCRIPTION

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

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patient's dentition. 3Shape A/S Ortho System 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.

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL WITH THE PREDICATE DEVICE

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

Features	Submission Device	Predicate Device	ReferenceDevice
Manufacture	Johns DentalLaboratories	Great LakeOrthodontics, Ltd.	Motor City Dental Lab
Trade Name	Redline	Smart Moves Complete	ClearForm Aligners
510(k)Number	K213297	K172765	K191838
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470	21 CFR 872.5470
Classifications	Class II	Class II	Class II
Product Code	NXC	NXC	NXC
Indications forUse	The Redline Aligner isindicated for the	Smart Moves Completeis indicated for the	ClearForm Aligners areindicated for the
	treatment of toothmalocclusion inpatients withpermanent dentition(i.e., all secondmolars). The RedlineAligner positions teethby way of continuousgentle force.	treatment of toothmalocclusion inpatients with permanentdentition (i.e., allsecond molars). SmartMoves Completepositions teeth by wayof continuous gentleforce.	alignment of teeth inpatients with permanentdentition (i.e. all secondmolars) duringorthodontic treatment ofmalocclusions. Thealigners position teeth byway of continuous gentleforces
Mode ofActions	Orthodontic toothmovement occursthrough forces appliedby the appliance to thedentition as each toothfollows theprogrammeddisplacement based ona doctor's prescription.	Orthodontic toothmovement occursthrough forces appliedby the appliance to thedentition as each toothfollows theprogrammeddisplacement based ona doctor's prescription.	Orthodontic movementoccurs throughcontinuous gentle forcesapplied to the dentitionas each tooth follows theprogrammeddisplacement based on adoctor's prescription.
Material	PETG, thermoplastic	$0.03"$ ThermoplasticPETG	Essix thermoplastic
BiocompatibleSoftware	Yes3Shape A/S OrthoSystem uses a scan oftooth impression or adigital scan to generatethe image of a final,treated state and theninterprets a series ofimages that representintermediate teethstates. Once the dentalpractitioner approvesthe treatment plan, thesoftware converts thefiles to produce theseries of patientspecific aligners.	YesThe 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 specificaligners.	YesStandard 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 softwareconverts the files toproduce the series of patient specific aligners.
			models used to producethermoformed aligners.
ManufactureMethod	Thermoforming	Thermoforming	Thermoforming
Rx or OTC	Rx	Rx	Rx
Anatomylocation	Mouth; mucosamembranes	Mouth; mucosamembranes	N/A
Sterility	Non-sterile	Non-sterile	Non-sterile
Design	Image: clear aligner	Image: red aligner with text "smart moves complete"	Image: clear aligner

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The intended use of the Redline Aligner is the same as the primary predicate device. They are both intended for correcting dental malocclusion patients with permanent dentition. It has similar technological characteristic and fabricated by a similar manufacturing process to the predicate device. The application of the device is in the same clinical manner as the predicate device. Therefore, the Redline 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 Redline 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 Redline Aligner is manufactured by 3Shape A/S Ortho System. It is a 510(k) clearance (K180941) software under product code PNN for intended use.

An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing for Redline 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.

Translational measurement were within 0.150mm (150microns) of the target input value, the predefined tolerance of the manufacturing process. There were no statistical difference in the values measured from any of the groups. The testing results are within the acceptance criteria to demonstrate dimensional accuracy. Additionally, the final aligner fitness evaluation demonstrate all the aligners including in the study passed and were deemed an excellent fit .

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The biocompatibility evaluation and the determination that Redline Aligner and the predicate devices are composed of the same material, fabricated by the similar manufacturing processes, and are used in the same clinical application, which concludes that Redline Aligners are biocompatible for their 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".

Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on the final manufactured Redline Aligners .

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 Redline aligners have equivalent indication and method of use to its primary and reference devices, therefore there was no clinical testing to support this device.

CONCLUSION

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 conclusion, the device is substantially equivalent based on a comparison of intended use, and technological characteristics, the device is 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.