TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially positions teeth by way of continuous gentle force.

Device Description

TP Orthodontics Clear Aligner System consists of a custom-made series of plastic aligners that apply gentle pressure to teeth, gradually moving them into alignment. A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to TP Orthodontics along with the physician's prescription. TP Orthodontics, using a standard dental software used for teeth alignment, designs a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription. The set-up and intermediate stages are sent back to the physician for review and approval. Once the doctor has approved the model scheme, the aligners are produced using a thermoplastic material and shipped to the dental practitioner. The doctor delivers the aligners to the patient in sequential stages, provides instructions for use (such as when to change aligners), and monitors the case progression and fit and function from the first aligner through the end of treatment through follow-up appointments. Aligners must be worn by the patient most of the day (20-22h), being removed only for eating, drinking and performing oral hygiene and should be replaced every 2-3 weeks as prescribed by the doctor.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the TP Orthodontics Clear Aligner System and its substantial equivalence to predicate devices, thus the information provided focuses on the regulatory submission rather than a detailed scientific study. Therefore, some of the requested information regarding a device's performance study might not be explicitly present if it deviates from what is typically required for a 510(k) submission.

Here's the summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to predicate devices. For this type of device (clear aligners), this primarily involves demonstrating equivalent indications for use, technological characteristics, and safety profiles.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (TP Orthodontics Clear Aligner System)
Indications for Use	Treatment of tooth malocclusions in patients with permanent dentition by sequentially positioning teeth via continuous gentle force.	"Substantially equivalent indication for use" to predicate devices. Slight differences in wording but no impact on safety/efficacy.
Technological Characteristics	Similar design, material (biocompatible thermoplastic), mode of action (continuous gentle forces), method of use.	"Substantially equivalent...technological characteristics" to predicate devices. Made of co-polyester or co-polymer thermoplastic.
Clinical Performance	Well-established clinical performance for sequential aligners (product code NXC).	No new clinical testing performed; relied on established clinical performance of predicate devices.
Manufacturing Validation	Dimensional accuracy of aligners matches software output specifications.	"Validation demonstrated that the aligners manufactured match the software output specifications."
Biocompatibility	Made of biocompatible material.	Uses same thermoplastic material as predicate devices (Aligner Material from Dentsply, 510(k) K062828). No new testing performed.
Software Verification & Validation	Software used with the device is validated.	"Both software used with TP Orthodontics Clear Aligner System passed their validations."

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

The document explicitly states: "therefore there was no clinical testing to support this device." This means there was no specific test set of patients used for a clinical performance study of the TP Orthodontics Clear Aligner System. The device's clinical performance relies on the established performance of predicate devices.

For the non-clinical manufacturing validation, the sample size is not specified, nor is the data provenance.

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

Not applicable as no specific clinical 'test set' was used for this device in a de novo study. The ground truth for the overall category of sequential aligners (NXC) would have been established through years of clinical practice and research by orthodontists and dental professionals, leading to the FDA's clearance of the first device in 1998.

4. Adjudication Method for the Test Set

Not applicable as no specific clinical 'test set' was used for a new study on this device.

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

Not applicable. This device is a physical medical device (clear aligner system), not an AI-assisted diagnostic or treatment planning system that would involve human "readers" or AI assistance in the way typically discussed in a MRMC study. The software mentioned is for designing the aligners, not for diagnostic interpretation by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable for a physical clear aligner device. The "software" mentioned passed its validations, which would imply standalone testing of the software's functionality, but this is not an "algorithm only" performance for diagnosis or treatment decision making in the typical sense.

7. The Type of Ground Truth Used

For the specific device, the ground truth for regulatory clearance was demonstration of substantial equivalence to predicate devices. This means that its design, materials, manufacturing, indications for use, and overall safety and effectiveness were compared against devices already legally marketed and proven effective.

For the manufacturing validation, the ground truth would be the software output specifications (i.e., the aligners were produced accurately according to the digital design).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set" in the computational sense. The design of the aligners is based on dental software that applies established biomechanical principles and clinician input, not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no computational "training set" was used for this device.

Summary

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November 12, 2020

TP Orthodontics Inc. Stephanie Thyen QA/RA Manager 100 Center Plaza La Porte, Indiana 46350-9672

Re: K193385

Trade/Device Name: TP Orthodontics Clear Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 24, 2020 Received: October 5, 2020

Dear Stephanie Thyen:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K193385

Device Name

TP Orthodontics Clear Aligner System

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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Image /page/3/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a blue globe with an arrow wrapping around it on the left side. To the right of the globe is the text "TP Orthodontics, Inc." in a simple, sans-serif font.

K193385

November 20, 2019

510(k) Summary

Submitter Information:

TP Orthodontics, Inc. 100 Center Plaza, La Porte, IN Contact Person: Cristiane Muller Phone Number: 1.800.348.8856 / 219.785.2591 Fax: 219.324.3029 E-mail: cristiane.muller@tportho.com

Device Information:

Trade Name: TP Orthodontics Clear Aligner System Common Name: Aligners, Sequential Product Code: NXC Classification Name: Orthodontic Plastic Bracket Regulation Number: 872-5470 Device Class: II Classification Panel: Dental

Predicate Devices:

Device	Applicant	510(k) Number
3M Clear Tray Aligner	3M Unitek Corporation	K163689

Reference Predicate Devices:

Device	Applicant	510(k) Number
Ortho System	3Shape A/S	K180941
Mouthguard and AlignerMaterial	Dentsply International	K062828
MTM Clear Aligner	Dentsply Sirona	K163155

Indications for Use:

Device Description and Summary of Technological Characteristics:

TP Orthodontics Clear Aligner System consists of a custom-made series of plastic aligners that apply gentle pressure to teeth, gradually moving them into alignment.

A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to TP Orthodontics along with the physician's prescription.

TP Orthodontics, using a standard dental software used for teeth alignment, designs a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription. The set-up and intermediate stages are sent back to the physician for review and approval. Once the doctor

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has approved the model scheme, the aligners are produced using a thermoplastic material and shipped to the dental practitioner.

The doctor delivers the aligners to the patient in sequential stages, provides instructions for use (such as when to change aligners), and monitors the case progression and fit and function from the first aligner through the end of treatment through follow-up appointments.

Aligners must be worn by the patient most of the day (20-22h), being removed only for eating, drinking and performing oral hygiene and should be replaced every 2-3 weeks as prescribed by the doctor.

Characteristic	TP OrthodonticsClear AlignerSystemProposed Device	3M Clear TrayAlignerPrimary Predicate	MTM Clear AlignerReferencePredicate	Comparison
510(k)	To be determined	K163689	K163155	N/A
Manufacturer	TP Orthodontics,Inc.	3M UnitekCorporation	Dentsply Sirona/Raintree Essix Inc.	N/A
Regulation Number	21 CFR 872.5470	21 CFR 872.5470	21 CFR 872.5470	Same
Device	Orthodontic PlasticBracket	Orthodontic PlasticBracket	Orthodontic PlasticBracket	Same
Classification Name	Orthodontic PlasticBracket	NXC	NXC	Same
Product Code	NXC	NXC	NXC	Same
Device Class	Class II	Class II	Class II	Same
Indications for Use	TP OrthodonticsClear AlignerSystem consists of aseries of plasticappliances indicatedfor the treatment oftooth malocclusionsin patients withpermanent dentition(i.e. all secondmolars). Utilizing aseries ofincremental toothmovements, TPOrthodontics ClearAligner Systemsequentiallypositions teeth byway of continuousgentle force.	The 3M Clear TrayAligner System is aseries of clear,lightweight, plasticappliances indicatedfor the treatment oftooth malocclusionsin patients withpermanent dentition(i.e. all secondmolars). Utilizing aseries of incrementaltooth movements, itsequentially positionsteeth by way ofcontinuous gentleforce.	MTM® Clear Aligneris indicated for thetreatment of anteriortooth malocclusionsin patients withpermanent dentition(i.e. all secondmolars). Utilizing aseries ofincremental minortooth movements,MTM® Clear Alignersequentiallypositions teeth byway of continuousgentle force.	Similar. Theverbiage of theindications for useis slightly differentthan the primaryand referencepredicates,however, theseslight differences inwording do notchange theintended use of thesubject device inrelation to thepredicate devicesand does not raiseany new questionsabout safety andeffectiveness.
Intended Population	Individuals withpermanent dentition	Individuals withpermanent dentition	Individuals withpermanent dentition	Same
Material	Co-polyester or co-polymer;Thermoplastic	Thermoplastic	Co-polyester or co-polymer;Thermoplastic	Similar. All devicesare made of abiocompatiblethermoplasticmaterial.
Mode of action	Continuous gentleforces applied toteeth to attainorthodontic toothmovement	Continuous gentleforces applied toteeth to attainorthodontic toothmovement	Continuous gentleforces applied toteeth to attainorthodontic toothmovement	Same
Characteristic	TP OrthodonticsClear AlignerSystemProposed Device	3M Clear TrayAlignerPrimary Predicate	MTM Clear AlignerReferencePredicate	Comparison
Method of Use	Aligners are worn bythe patientaccording to thetreating doctorprescription.	Aligners are worn bythe patient accordingto the treating doctorprescription.	Aligners are worn bythe patientaccording to thetreating doctorprescription.	Same
Software Used forOrdering Workflow	Yes	Yes	Yes	Same
Prescription (Rx) orOver-the-Counter(OTC)	Rx	Rx	Rx	Same
Design of Aligners	Image: Clear aligner	Image: Clear aligner	Image: Clear aligner	Same. All arecomprised of clearthermoplastic traysthat seat over theteeth.

Table 5.1. Substantial Equivalence Comparison

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Image /page/5/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a stylized globe with blue lines and an arrow wrapping around it. To the right of the globe is the text "TP Orthodontics, Inc.", with "TP" in a slightly larger font size than the rest of the text.

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. TP Orthodontics Clear Aligner System have equivalent indication and method of use to its primary and reference predicate devices, therefore there was no clinical testing to support this device.

Non-Clinical Performance Data

A manufacturing validation was performed to ensure the dimensional accuracy of TP Orthodontics Clear Aligner System and assess the integration between the steps of the manufacturing process. The validation demonstrated that the aligners manufactured match the software output specifications. Physical properties testing was obtained from the clearance for the Aligner Material from Dentsply, 510(k) K062828.

Biocompatibility Testing

Biocompatibility tests were not performed as TP Orthodontics Clear Aligner System are made of the same material (thermoplastic material) as its primary and reference predicate devices. The material used (Aligner Material from Dentsply, 510(k) K062828) is the same used in the fabrication of MTM aligners (reference predicate device), and therefore there are no differences in biocompatibility between them. Biocompatibility testing data was obtained from the clearance for the Aligner Material from Dentsply, 510(k) K062828.

Software Verification and Validation Testing

Both software used with TP Orthodontics Clear Aligner System passed their validations.

Substantial Equivalence Conclusion

TP Orthodontics Clear Aligner System presents substantially equivalent indication for use and technological characteristics as its primary and reference predicate devices. There are slight differences in the language of the indications for use, however these differences do not impact safety and efficacy of the device.

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Image /page/6/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a blue globe with an arrow wrapping around it. The text "TP Orthodontics, Inc." is written in a simple, sans-serif font to the right of the globe. The logo is clean and professional, and the blue color gives it a sense of trustworthiness.

It is concluded that TP Orthodontics Clear Aligner System is safe, effective, and substantially equivalent to its primary and reference predicate devices.

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.