The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner positions teeth by way of continuous gentle force.

Device Description

The ClearPath clear aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The aligners are provided non-sterile and are customized for each patient according to the dental clinician's prescription.

The dental health professional (dentist/orthodontist) takes provides physical or scanned impressions of the patient's teeth to ClearPath. A digital setup of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked.

The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

AI/ML Overview

The provided text describes the ClearPath Aligner, a series of clear plastic appliances for correcting dental malocclusion. The submission (K202857) seeks substantial equivalence to a predicate device (K162609). The key difference is the new device's use of software (Ortho Analyzer, 3Shape A/S, K180941) for treatment planning and 3D printing of models.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative (e.g., minimum accuracy, sensitivity, specificity) acceptance criteria for the device from a clinical performance standpoint for the software's functionality. Instead, the focus is on the manufacturing process and materials.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility	Satisfied: Testing of the plastic thermoformable material and ISO 10993-5 Cytotoxicity Testing of the finished thermoformed aligner were provided.
Manufacturing Process Accuracy (Digital vs. Physical)	Satisfied: Bench testing was performed to validate the manufacturing process to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan.
Material Equivalence	Satisfied: The thermoplastic materials used are the same as the predicate ClearPath Aligner.
Functional Equivalence (with predicate aligner)	Satisfied: The ClearPath Aligner has the same intended use as the predicate device. There are no fundamental technological differences between the Predicate and the modified device. The difference is the use of referenced software during specified manufacturing steps.

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

The document explicitly states that "Bench testing was performed to validate the manufacturing process: to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan."

Sample Size for Test Set: The exact sample size for this bench testing is not specified in the provided text.
Data Provenance: The nature of the bench testing suggests it would be prospective data generated specifically for this validation. The country of origin of the data is not specified, but the applicant's address is Lahore-Pakistan.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the bench testing. Given the type of testing (accuracy of thermoformed aligner vs. digital scan), ground truth would likely be established through precise metrological measurements, not expert clinical assessment in this context.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method, as the testing described is bench testing for manufacturing accuracy, not a clinical study involving human interpretation or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done or reported. The submission focuses on the substantial equivalence of the device, primarily through material and manufacturing process validation, and not on the comparative effectiveness of human readers with or without AI assistance. This device is not an AI diagnostic tool that assists human readers.

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

The document mentions that the software system (Ortho Analyzer) is used for "management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models."

However, a standalone performance study specifically for the algorithm's accuracy in these tasks, independent of the human-in-the-loop manufacturing process, is not explicitly described or quantified in terms of specific metrics (e.g., accuracy of tooth movement simulation). The bench testing described validates the manufacturing process based on the digital plan, rather than the intrinsic diagnostic or planning accuracy of the software itself in a standalone context.

7. The Type of Ground Truth Used

For the bench testing, the ground truth was the initial digital scan used as the reference against which the final thermoformed physical aligner was compared for accuracy. This implies a precise, measurable digital model.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The device is an orthodontic aligner and the new part of the submission relates to the use of existing software in its manufacturing process. There's no indication that a new algorithm or AI model was developed by ClearPath Orthodontics that required a separate training set. The "Ortho Analyzer" software itself would have had its own development and validation, but that information is not part of this 510(k) submission for the ClearPath Aligner.

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

As no training set is discussed for the ClearPath Aligner device itself (other than potentially for the pre-existing Ortho Analyzer software), this information is not provided in the document.

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

January 5, 2021

ClearPath Orthodontics Ltd % Patsy Trisler Regulatory Consultant Oserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K202857

Trade/Device Name: ClearPath Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 25, 2020 Received: September 28, 2020

Dear Patsy Trisler:

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

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

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 medical devices and radiation-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 Michael Adjodha Assistant Director DHT1B: Division of Dental 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}------------------------------------------------

Indications for Use

510(k) Number (if known) K202857

Device Name

ClearPath Aligner

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}------------------------------------------------

K202857

510(k) SUMMARY

SUBMITTER
Submitter Name:	ClearPath Orthodontics, Ltd
Submitter Address:	6-N Main BoulevardJohar TownLahore-Pakistan, 54000
Contact Person:	Dr. Waqas Wahab, Chief Executive Officer
Email:	Waqas.wahab@clearpathortho.com
Telephone:	+92 322 491 33 77
Date Prepared:	September 25, 2020
DEVICE
Device Trade Name:	ClearPath Aligner
Common Name:	Aligner, Sequential (Clear Braces)
Classification NameNumber	Orthodontic Plastic Bracket21 CFR 872.5470
Product Code	NXC
Regulatory Class	2
Review Panel	Dental
PREDICATE DEVICE	Primary Predicate:K162609, ClearPath Aligner, ClearPath OrthodonticsReference Device:K180941 Ortho System™, 3Shape A/S
DEVICEDESCRIPTION	The ClearPath clear aligner is comprised of a series of clear,thin, thermoformed removable aligner trays that are designed tocorrect tooth malocclusions without the use of conventionalwire and bracket orthodontic technology. The aligners areprovided non-sterile and are customized for each patientaccording to the dental clinician's prescription.The dental health professional (dentist/orthodontist) takesprovides physical or scanned impressions of the patient's teethto ClearPath. A digital setup of either the scanned impressionor a scan of the physical impression is sent to the clinician forapproval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed onthe molds and laser marked.The finished, customized aligners are provided to the dentalhealth care professional who provides them to the patient,confirming fit and design. The aligner trays are held in place bypressure and can be removed by the patients at any time.
MECHANISM OFACTION	Based on a clinician's prescribed treatment plan, each aligner inthe set is used for the specified period of time to exert gentleforce to achieve progressive realignment of the teeth until thefinal correction has been achieved. Standard treatment time foreach aligner tray is 2-3 weeks, worn by patient for 22 hours perday.
SUMMARY OFTECHNOLOGICALCHARACTERISTICS	The thermoplastic materials used for the manufacture of theClearPath aligner is the same material used to make thepredicate ClearPath Aligner.
	The software system used is Ortho Analyzer, 2019 ver 1.8.1.0by 3Shape A/S (Reference device - K180941). It is used formanagement of 3D scanned orthodontic models, orthodonticdiagnosis by measuring, analyzing, inspecting and visualizing3D scanned orthodontic models, virtual planning of orthodontictreatments by simulating tooth movements, and design oforthodontic appliances based on 3D scanned orthodonticmodels.
INDICATIONS FORUSE STATEMENT	The ClearPath Aligner is a series of clear, lightweight, plasticappliances indicated for the correction of dental malocclusion inpatients with permanent dentition (i.e. all second molars). TheClearPath Aligner positions teeth by way of continuous gentleforce.
SAFETY TESTING	Biocompatibility: Testing of the plastic thermoformable materialused to make the ClearPath Aligner has been provided to FDApreviously.
	ISO 10993-5 Cytotoxicity Testing of the finished thermoformedaligner was provided.
PERFORMANCETESTING	Bench testing was performed to validate the manufacturingprocess: to ensure the accuracy of the final thermoformedaligner compared to the initial digital scan.
	In vivo Animal and Human Clinical performance testing are notrequired for this device category.
COMPARISON TOTHE PREDICATEDEVICE	The ClearPath Aligner has the same intended use as thepredicate device. There are no fundamental technologicaldifferences between the Predicate and the modified device.The difference between the new and predicate devices is in theuse of the referenced software during specified steps in themanufacturing process.
SUBSTANTIALEQUIVALENCECONCLUSION	The information and data provided in this 510(k) establish thatthe ClearPath Aligner is substantially equivalent to the predicateClearPath Aligner in the intended use, design, principle ofoperation, technology, and thermoformable material used tomake the aligner. Comparison of all key parameters arepresented in the following SE Comparison table

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

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

	Proposed Device	Predicate DeviceK162609
Device Name	ClearPath Aligner	ClearPath Aligner
Manufacturer	ClearPath Orthodontics, Ltd	ClearPath Orthodontics, Ltd
ClassificationRegulation NameProduct CodeClass	21 CFR 872.5470Orthodontic Plastic BracketNXC2	21 CFR 872.5470Orthodontic Plastic BracketNXC2
Indications forUse	The ClearPath Aligner is a series ofclear, lightweight, plastic appliancesindicated for the correction of dentalmalocclusion in adult andadolescent patients with permanentdentition (i.e. all second molars).The ClearPath Aligner positionsteeth by way of continuous gentleforce.	The ClearPath Aligner is a series ofclear, lightweight, plastic appliancesindicated for the correction of dentalmalocclusion in patients withpermanent dentition (i.e. all secondmolars). The ClearPath Alignerpositions teeth by way of continuousgentle force.
Mode of Action	The appliance applies gentle forceson teeth according to the planprescribed by the doctor.	The appliance applies gentle forceson teeth according to the planprescribed by the doctor.
Description ofUse	Each removable preformed plastictray is worn by the patient asprescribed by the doctor, usually afew weeks prior to using the nextsequential aligner tray.	Each removable preformed plastictray is worn by the patient asprescribed by the doctor, usually afew weeks prior to using the nextsequential aligner tray.
Material	Thermoformed plastic	Thermoformed plastic
Software Used	Yes, for treatment planning and 3Dprinting of models.	No
Prescription Use	Rx	Rx
Biocompatibility	Yes, shown to meet requirements	Yes, shown to meet requirements
ValidationTesting	Yes, performed	Yes, performed.

Substantial Equivalence Comparison Table

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.