Arkligners are indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

Device Description

The Arkligners device is fabricated of clear thin thermoformed Essix Ace plastic in sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.

Clinicians scan a patient, export the views needed for the patient model, and sends these scans to Arklign Laboratories. They import them into 3Shape Dental Manager 2020 to create a patient model. The patient model is imported into 3Shape Ortho System 2021 Clear Aligner Studio to design the models to make clear aligners for the treatment plan the clinician has ordered. This treatment plan (with models needed to make aligners for whichever treatment phases are being ordered) is then exported and sent to the clinician along with the original patient model file for them to approve. Then Arklign Laboratories exports the approved models needed to make the specific aligners ordered to Formlabs Form 2 3D printer running Formlabs PreForm 3.12.0. The aligner is thermoformed over the printed model. Every aligner is checked for fit on the printed patient model before sending to the clinician.

AI/ML Overview

The provided text is a 510(k) summary for Arkligners, a type of orthodontic aligner. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with acceptance criteria and device performance results. As such, the information needed to fully answer the request is not present in the provided text.

Specifically, the document states: "Arkligners were checked for fit on the relevant patient model by lab personnel doing measurements and two clinicians using clinical criteria for fit." This is the only mention of performance evaluation. It does not provide quantitative acceptance criteria, reported performance values, sample sizes, expert qualifications, or details about adjudication methods.

Therefore, I can only partially address your request based on the very limited information available.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It only mentions that "Arkligners were checked for fit on the relevant patient model by lab personnel doing measurements and two clinicians using clinical criteria for fit."

Based on the limited information, a table cannot be constructed with specific acceptance criteria and reported numeric performance values.

Study Details for Device Performance

Sample size used for the test set and the data provenance:
- Sample size: The document mentions "patient scans representing three specific clinical scenarios" were used for manufacturing validation and fit checks. This indicates a sample size of n=3 clinical scenarios. It's unclear if this equates to 3 individual patient models or more.
- Data Provenance: The data provenance is not explicitly stated (e.g., country of origin). The study appears to be descriptive of a manufacturing validation process rather than a formal clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: "two clinicians" were used for fit checks.
- Qualifications: The qualifications of these clinicians are not explicitly stated, beyond being referred to as "clinicians working with Arklign."
Adjudication method for the test set:
- The document states "lab personnel doing measurements and two clinicians using clinical criteria for fit." This suggests a process where both lab personnel and clinicians evaluated fit. However, no specific adjudication method (like 2+1 or 3+1 consensus) is described for resolving disagreements or establishing a definitive "ground truth" for fit.
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, an MRMC comparative effectiveness study was not done. The document describes a manufacturing validation and fit check process, not a reader study involving human interpretation of data/images, nor does it involve AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. The device itself is the physical aligner, created through a digital workflow but ultimately a physical product. The "fit" was checked by human lab personnel and clinicians.
The type of ground truth used:
- The "ground truth" for the fit check was based on "clinical criteria for fit" as judged by two clinicians, and "measurements" by lab personnel. This can be categorized as expert judgment/clinical criteria.
The sample size for the training set:
- The document mentions "patient scans representing three specific clinical scenarios" were used for manufacturing validation and design. It's unclear if this refers to the training of the software workflow (3Shape Dental Manager, 3Shape Ortho System Clear Aligner Studio) or the aligner manufacturing process. However, no separate "training set" for a device performance study is described. The focus is on the manufacturing process and material safety/equivalence.
How the ground truth for the training set was established:
- This information is not provided as there isn't a clearly defined "training set" for a performance study in the context of this 510(k) summary. The "treatment plan" for generating the aligners was determined by "Clinicians working with Arklign."

Summary

{0}------------------------------------------------

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 & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 12, 2022

Arklign Laboratories % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

Re: K220835

Trade/Device Name: Arkligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: June 1, 2022 Received: June 13, 2022

Dear Angela Blackwell:

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.

{1}------------------------------------------------

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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K220835

Device Name Arkligners

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K220835

Arkligners 510K Summary March 10, 2022

Name and Address: Arklign Laboratories 2526 Qume Dr Suite 15 San Jose, CA 95131 Contact Person: Rex Ho Email: rho@arklign.com Telephone: (800) 361 1659 Website: www.arklign.com

Name of device: Arkligners Common name: Sequential aligners Classification Name: Orthodontic Plastic Bracket CFR: 21 CFR 872.5470 Primary Product Code: NXC Class: Il Submission Contact:

Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com

Device Description: The Arkligners device is fabricated of clear thin thermoformed Essix Ace plastic in sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.

{4}------------------------------------------------

Indications for Use: Arkligners are indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

Technological Characteristics:

Treatment of tooth malocclusions via a series of intraoral plastic appliances designed to provide forces for incremental movement of targeted teeth to a desired final position is the technological principle for both the subject device and the predicate device.

Mechanism of Action:

The mechanism of action is similar to the predicate devices. Orthodontic targeted tooth movement occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.

Testing Summary: The material used for the Arkligners is Essix Ace 1mm thick disks. This same Dentsply Esssix Ace was cleared In K062828 and the same material is used in the predicate device BRIUS Clear Aligners. Literature studies show this material has sufficient wear properties for this indication. Literature studies used the same thickness of Essix Ace (1mm).

A biocompatibility assessment of Essix Ace was evaluated during its 510k clearance. A cytotoxicity test was conducted to show the contact of the Essix Ace disk with the model made from Formlabs Draft Resin V2 did not change the non-cytotoxic nature of the Essix Ace.

Arklign conducted manufacturing validation with 3Shape Ortho System 2021 Clear Aligner Studio being used to fabricate the models used to produce aligners and based upon patient scans representing three specific clinical scenarios. Clinicians working with Arklign determined the treatment plan. The software used to create the original digital patient model was 3Shape Dental Manager 2020. This model was exported to the 3Shape Ortho System 2021 Clear Aligner Studio for creation of the models to form aligners over. Once the models to form aligners were designed then the designs were exported to Formlabs PreForm 3.12.0 being run on a Formlabs Form 2 3D printer and printed using Formlabs Draft Resin V2.

Arkligners were created over the models by using a Scheu-Dental BioStar thermoforming machine. Settings for this thermoforming machine for Essix Ace 1mm thick disks are found in the instructions for use accompanying the Essix Ace disks. Arkligners were checked for fit on the relevant patient model by lab personnel doing measurements and two clinicians using clinical criteria for fit.

Predicate Device: K202792 BRIUS Clear Aligners

Reference Devices: K062828 Dentsply Essix

{5}------------------------------------------------

Substantial Equivalence:

Device	Arkligners	BRIUS ClearAlignersK202792	Dentsply EssixK062828
RegulationNumber	21 CFR872.5470	21 CFR872.5470	unclassified
DeviceClassificationName/DeviceCommonName	OrthodonticPlasticBracket	OrthodonticPlasticBracket	Prescriptionmouthguard/Mouthguardand Aligner Materials
Product Code	NXC	NXC	MQC
Classification	II	II	unclassified
Indicationsfor use	Arklignersare indicatedfor thetreatment oftoothmalocclusionin patientswithpermanentdentition (i.e.all secondmolars). Thealignerspositionteeth by wayofcontinuousgentle force.	BRIUS ClearAligners areindicated foruse in thealignment ofpermanentteeth (i.e. allsecondmolars)throughorthodontictreatment ofmisalignmentandmalocclusion.The alignersguide teeth totheir finalposition bywayof continuousgentle forces.	MOUTHGUARD ANDALIGNER MATERIALS areindicated for thefabrication of orthodonticand dental appliancessuch as aligners, biteplanes, mouthguards,nightguards, snoringappliances, splints,retainers, repositioners,and temporary bridges.
Mode ofaction	Orthodontictoothmovementoccursthroughforcesapplied	Orthodontictoothmovementoccursthroughforces applied
	by theappliance tothedentition aseach toothfollows theprogrammeddisplacementbased on adoctor'sprescription.	by theappliance tothedentition aseach toothfollows theprogrammeddisplacementbased on adoctor'sprescription.
Material	DentsplyEssixThickness of1mm	Dentsply EssixThickness of$\frac{3}{4}$ , 7/8 and 1mm	Dentsply Essix AceThicknesses of $\frac{3}{4}$ , 7/8 and1 mm

{6}------------------------------------------------

Conclusion: Based on materials, technological characteristics, mechanism of action, indications for use and the results of non-clinical performance testing, Arkligners are substantially equivalent to BRIUS Clear Aligners K202792.

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.