The Ormco™ Spark™ Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The Ormco™ Spark™ Aligner System positions teeth by way of continuous gentle force.

Device Description

The Ormco™ Spark™ Aligner System consists of a series of doctor-prescribed, custom manufactured, clear plastic removable orthodontic appliances (aligners) that incrementally move the patient's teeth from an original state to a treated state. Treatment planning, aligner design and aligner manufacture are supported by a proprietary software system. The Ormco™ SparkTM Aligner system consists of multiple interfacing software modules; Web, Design, Approver and Fabrication. The Spark Aligner Web software module is an online portal, where clinicians can create new patient profiles, plan treatments, manage patients and submit prescriptions, photos, images and digital scans to Ormco. Ormco technicians use a reference Anatomy software and the Ormco™ Spark™ Aligner Design software to create a 3D model of the patient's teeth from dental scans and to generate a 3D image of a final, treated state, as well as 3D aligner transitional treatment stage models, and submits them to the clinician. The clinician uses the Approver Software to review and approve the models, then Ormco uses the Fabrication software to produce resin molds for thermoforming the aligners.

The clinician receives the aligners and provides them, in sequential "stages", to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligner. The trays are held in place by pressure and can be removed by the patient at any time.

Several treatment options may be integrated into the Ormco Spark/Kappa aligner. Attachments or "buttons" may be prescribed by the dental practitioner to facilitate tooth movement and aligner anchorage. The dental practitioner may choose a standard dental composite and adhesive to bond the attachments to the dentition. The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Hooks may be designed into the aligner, then connected by an elastic to a toothbonded button on the opposite arch. to apply additional forces. Bite ramps are step features built into the lingual surfaces of the upper aligner arch that used by the clinician to prevent movement of the teeth during overbite correction treatment. Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to address voids of missing teeth or other gaps during treatment.

AI/ML Overview

The provided text describes the Ormco™ Spark™ Aligner System and its substantial equivalence to a predicate device, the Invisalign System (K143630). However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria through specific performance metrics. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics, performance testing, and a literature review.

Therefore, the requested information elements related to the acceptance criteria and a study proving the device meets them cannot be fully extracted as they are not explicitly present in the provided text.

Here's a breakdown of what can be extracted or inferred based on the supplied document, addressing the prompt's points where possible:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria with numerical targets and reported performance values for those targets. Instead, it discusses "performance testing" to demonstrate substantial equivalence to the predicate device.

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary from document)
Mechanical Properties	Stress relaxation, flexural, and tensile strength comparable to Zendura Aligner and Invisalign's SmartTrack Aligner material.
Material Properties	Translucency, staining, shelf life, and shipping properties of TruGEN™ material found "acceptable for all tested samples."
Aligner Feature Accuracy	Attachment dimensional accuracy, cutout effects on stability, force evaluation of attachments, and bite ramp and hook evaluation found "acceptable at specified cycles."
Biocompatibility	Met ISO10993-1 standards, including cytotoxicity, sensitization, irritation, and intracutaneous reactivity.
Technological Characteristics	Design, technology, and composition are "substantially equivalent" to the predicate Invisalign System (K143630).
Clinical Performance	No specific clinical performance criteria or direct testing mentioned for the proposed device; relies on literature review and predicate device's established safety and efficacy.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified for any of the performance tests. The document only mentions "all tested samples" for material property tests (translucency, staining, shelf life, shipping) and "specified cycles" for aligner features.
Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. The performance testing appears to be bench testing conducted by the manufacturer ("Ormco").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document mentions "orthodontic specialists" conducted a "comprehensive scientific literature review and analysis" to support substantial equivalence, but not for establishing ground truth for a test set of the proposed device.

4. Adjudication method for the test set

This information is not provided. There is no mention of an independent adjudication method for performance tests.

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 comparative effectiveness study was done or mentioned. The device described (Ormco™ Spark™ Aligner System) is a physical orthodontic appliance system, not an AI-assisted diagnostic or treatment planning tool that would typically involve human "readers" or "AI assistance" in the sense of image interpretation. The software components described are for treatment planning, design, and manufacturing workflow, not for AI-driven interpretation or assisted reading by human experts.

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

This question is not directly applicable. The "algorithm" here refers to the software that assists in designing and manufacturing the aligners. The overall device is a system involving both software and physical aligners, prescribed and managed by a dental professional. The performance tests evaluate the physical properties of the aligners and the accuracy of certain features, not the standalone diagnostic performance of an algorithm.

7. The type of ground truth used

For the physical and material performance tests (stress relaxation, flexural/tensile strength, translucency, staining, shelf life, shipping, attachment accuracy, etc.), the ground truth would implicitly be measured physical and chemical properties against established industry standards or comparable predicate device properties.
For biocompatibility, the ground truth was adherence to ISO 10993-1 standards.
For the overall claim of substantial equivalence, the "ground truth" for efficacy and safety relies heavily on the established performance and safety record of the predicate device (Invisalign System) and general scientific literature on clear aligners, as no clinical performance testing was done on the proposed device.

8. The sample size for the training set

This information is not provided. The document describes a "proprietary software system" with "multiple interfacing software modules" for treatment planning, aligner design, and manufacture. If these modules involve machine learning, no details about training set size are given. Given the nature of the device (orthodontic aligners), "training set" may refer to data used for software development and design rather than a clinical AI model training.

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

This information is not provided. As with point 8, if there's an AI/ML component implying a "training set," the document does not elaborate on how ground truth for such a set would be established. For traditional software development, "ground truth" might align with engineering specifications and clinical requirements documented by the developers and dental professionals.

Summary

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October 11, 2018

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Sybron Dental Specialties % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K182826

Trade/Device Name: Ormco Spark Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: October 3, 2018 Received: October 5, 2018

Dear Mark Job:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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 -S3

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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SECTION 4. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K 182826

Device Name

Ormco™ Spark™ Aligner System

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)

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. "

FORM FDA 3881 (7/17) Publishing Services (301) 443-6740

PSC

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SECTION 5. 510(k) SUMMARY FOR ORMCO™ SPARK™ ALIGNER SYSTEM

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K182826

510(k) SUMMARY for Ormco™ Spark™ Aligner System

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR $807.92, the following summary of information is provided:

1. Submitter Information:
  Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687

Primary Contact:	Mey Saied
Telephone Number:	909-962-5675
Fax Number:	909-962-5694

Alternate Contact:	Valerie Cimmarusti
Telephone Number:	714-516-7476
Fax Number:	909-962-5694

Date Prepared: September 12, 2018

1. Device Name:

Proprietary Name:	Ormco™ Spark™ Aligner System
Classification Name:	Aligner, Sequential
Regulation Description:	Aligner, Sequential
CFR Number:	872.5470
Device Class:	II
Product Code:	NXC

1. Predicate Device:
  The Ormco™ Spark™ Aligner System is substantially equivalent (as defined in 21 U.S.C. $ 360c(i)) for all regulatory purposes to the legally marketed device Invisalign System K143630 cleared on November 18, 2015, product code NXC, by Align Technology.

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Description of Device: 4.

Ormco also intends to trademark the Ormco Spark Aligner System as: Ormco Kappa Aligner System, Ormco Clear Aligner System, and Ormco Spark Clear Aligner System.

5. Indications for Use:

6. Mode of Action:

The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence (as defined in 21 U.S.C. § 360c(i)). Orthodontic tooth movement

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occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental clinician's prescription.

7. Description of Substantial Equivalence:

The Ormco™ Spark™ Aligner System is substantially equivalent (as defined in 21 U.S.C. $ 360c(i)) for all regulatory purposes to the predicate device Invisalign (K143630). For purposes relevant to this regulatory filing, and as discussed in the previous subsections, technological characteristics, performance testing and clinical literature review indicate the substantial equivalence of the Ormco™ Spark™ Aligner System to the Primary Predicate, Invisalign Aligner System. There is sufficient information demonstrating that the proposed subject device provides a reasonable assurance of safety and efficacy. Both products represent new incarnations of an evolving technology with a long history of development.

a) Technological Characteristics:

The technological principle for both the subject Spark/Kappa Aligner and predicate Invisalign Aligner is the treatment of tooth malocclusions using a series of plastic appliances that incrementally moves teeth to a desired end-state. A comparison between the technological characteristics of the Ormco™ Spark™ Aligner System and that of legally marketed predicate device, Invisalign (K143630) has is summarized in Table 5.1, and demonstrates that the design, technology and composition of the Ormco™ SparkTM Aligner System are substantially equivalent (as defined in 21 U.S.C. § 360c(i)) for all regulatory purposes to the predicate devices.

b) Performance Testing:

The performance data compares the software, design, treatment characteristics and treatment process of the Spark Aligner to the predicate Invisalign Aligner. The stress relaxation, flexural and tensile strength were compared to the commercially-available Zendura Aligner material, as well as Invisalign's SmartTrack Aligner material. Comparison of mechanical testing of Spark Aligner material (TruGEN) and Invisalign Aligner material (SmarkTrack) indicates the substantial equivalence of their technological characteristics.

Bench testing of aligners was not performed due to the difficulty of evaluating these device types in a laboratory; however, translucency, staining, shelf life and shipping tests were carried on the thermoformed TruGENTM material which showed acceptable properties for all tested samples. Additionally, several aligner features were tested and found to be acceptable including attachment dimensional accuracy, cutout effects on stability, force evaluation of attachments and bite ramp and hook evaluation at specified cycles.

Biocompatibility testing performed on both TruGEN material and Spark aligners per ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process included cytotoxicity, sensitization and irritation, and intracutaneous reactivity evaluation.

The performance data demonstrates substantial equivalence of the subject Spark Aligner device to the Predicate Invisalign Aligner device.

c) Clinical Performance Data:

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Clinical performance testing has not been completed for the Ormco™ Spark™ Aligner System. A comprehensive scientific literature review and analysis was conducted by orthodontic specialists on behalf of Ormco (please see Appendix A). Research articles and reports on the predicate device covered various subjects including the efficacy of the aligner on treating different types of orthodontic malocclusions.. There is sufficient information available from scientific literature and from the predicate devices to demonstrate that orthodontic, sequential, clear aligners provide reasonable assurance of safety and effectiveness.

d) Substantial Equivalence Comparison:

The following table (Table 5.1) compares the Ormco™ Spark™ Aligner System to the predicate device, the Invisalign System (K143630), as well as the reference device ClearCorrect (K113618). There is sufficient evidence to demonstrate substantial equivalence of the proposed Spark™ Aligner device to the predicate Invisalign (K143630) device.

Element	ProposedOrmco™ Spark™Aligner System	Primary PredicateInvisalign System	Reference PredicateClearCorrect
510(k) Number	Unknown	K143630	K113618
510(k) Sponsor	Sybron DentalSpecialties	Align Technologies	ClearCorrect, Inc
Regulation Number	21CFR872.5470	21CFR872.5470	21CFR872.5470
Device ClassificationName	Orthodontic PlasticBracket	Orthodontic PlasticBracket	Orthodontic PlasticBracket
Product Code	NXC	NXC	NXC
Device Class	Class II	Class II	Class II
Intended Use	Orthodontic toothmovement	Orthodontic toothmovement	Orthodontic toothmovement
Indications for Use	The Ormco™ Spark™Aligner System isindicated for thealignment of teethduring orthodontictreatment ofmalocclusion inpatients with permanentdentition (i.e., allsecond molars). TheOrmco™ Spark™Aligner Systempositions teeth by wayof continuous gentleforce.	The Invisalign Systemis indicated for thealignment of teethduring orthodontictreatment ofmalocclusion.	ClearCorrect System isindicated for thetreatment of toothmalocclusion inpatients with permanentdentition (i.e. allsecond molars), TheClearCorrect Systempositions teeth by wayof continuous gentleforce
Target users	Dental Professionals	Dental Professionals	Dental Professionals
Material	Thermoplasticpolyurethane -polyestercomposite resin	Thermoplasticpolyurethane -polyestercomposite resin	Thermoplasticpolyurethane resin
Description ofAppliance Application	Removable	Removable	Removable
Element	ProposedOrmco™ Spark™Aligner System	Primary PredicateInvisalign System	Reference PredicateClearCorrect
Mode of Action	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 toothmovement occursthrough forces appliedby the appliance to thedentition as each toothfollows theprogrammeddisplacement based ona doctor's prescription
Software Used forOrdering Workflow	Yes	Yes	Yes
Attachments	Available	Available	Available
Hooks/Cutouts	Available	Available	Not Available
Bite ramps	Available	Available	Not Available
Pontics	Available	Available	Available
Single Use	Yes	Yes	Yes
Non-Sterile Packaging	Yes	Yes	Yes
Treatment Process	Doctor uploadsPatient's dental scansinto proprietarysoftware; doctor usessoftware for caseviewing and treatmentplanning; Ormcotechnician receives caseand uses proprietary 3Dsoftware to generatemodels for the alignersbased on theprescription (desiredoutcome); Doctorapproves treatment planand final treated state;manufacturer crafts andproduces aligners:aligners and shipsthem to doctor, whothen provides them tothe patient, confirmingfit and design.	The proprietaryInvisalign System 3-Dsoftware generates theimage of a final, treatedstate and theninterpolates a series ofimages that representintermediate teethstates. The dentalpractitioner thenreviews these images todepict, edit, view,monitor, and approvean orthodontictreatment plan. Thedental practitioner hasthe option to reject orrequest modificationsto the set-up prior toapproving it for alignerfabrication. Once thedoctor approves the set-up, the series ofcustom-made alignersare then manufactured,packaged, and shippedto the dentalpractitioner to bedispensed to the patientfor treatment.	Doctor sends patientscans, molds andprescription toClearCorrect; Utilizingstandard dentalsoftware used for toothalignment,ClearCorrect designs aseries of plastic traysintended to graduallyrealign the patient'steeth in accordancewith the physician'sprescription. Theprescribing physicianreviews and approvesthe model schemebefore the molds areproduced. Onceapproved, ClearCorrectproduces the trays,which are formed ofclear, thinthermoformedpolyurethane plastic.The trays are sent backto the dental health careprofessional, who thenprovides them to thepatient, confirming fitand design.

Table 5.1: Comparison of Proposed and Predicate Devices

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e) Substantial Equivalence Conclusion:

The Ormco™ Spark™ Aligner System is substantially equivalent (as defined in 21 U.S.C. $ 360c(i)) for all regulatory purposes to the predicate device Invisalign (K143630). For purposes relevant to this regulatory filing, and as discussed in the previous subsections, technological characteristics, performance testing and clinical literature review indicate the substantial equivalence of the Ormco™ Spark™ Aligner System to the Primary Predicate, Invisalign Aligner System. Both products represent new incarnations of an evolving technology with a long history of development. There is sufficient information demonstrating that the proposed subject device provides a reasonable assurance of safety and efficacy.

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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.