OraMetrix sureclear™ aligners are orthodontic aligners fabricated from a clear, thin thermoformed plastic in a sequential series, individually customized for each patient based on a doctor's prescription to progressively reposition the teeth via gentle, corrective forces in the upper and lower dental arches.

The patient's dentist or orthodontist will use a digital scanning system to capture the anatomy and locations of the patient's teeth, and then after evaluating those will fill out an electronic prescription form describing the treatment plan using OraMetrix's previously cleared Suresmile® System software (K002620). The digitally scanned tooth data and prescription form are sent electronically via the Suresmile System® to OraMetrix technicians, using the Suresmile® System, separate the tooth scan data into individual tooth models representing the patient's malocclusion.

Additional OraMetrix technicians, also using the Suresmile® System's software, interpret the doctor's instructions provided on the prescription form; produce a setup and a sequence of intermediate models corresponding to each stage of the patient's aligner therapy. The setup and the intermediate stages are sent, via the Suresmile® System, back to the doctor for review, modification or approval. Once the doctor is satisfied with the planned therapy, an order for the production, packaging and shipment of the aligners is made via the Suresmile® System.

AI/ML Overview

Based on the provided text, the document is a 510(k) Premarket Notification for the OraMetrix Sureclear™ aligners. It focuses on demonstrating substantial equivalence to a predicate device (ClearCorrect System, K113618) rather than proving the device meets specific performance acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies cannot be extracted from this document, as such studies were explicitly stated as "Not required and not performed."

Here's why:

Device Type: The device is an orthodontic aligner.
Regulatory Pathway: The submission is a 510(k) premarket notification, which relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than requiring de novo clinical trials to establish safety and effectiveness.
Explicit Statement: The document explicitly states under "5.10 Clinical Performance Data":

"The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there was no clinical testing required to support sureclear™ aligners, as the indications for use is equivalent to the predicate device, which was not subjected to any clinical testing. The substantial equivalence of the subject device to the ClearCorrect System is supported by the non-clinical testing that was performed, along with other supporting documentation, and presented in this submission."

The "Relevant Testing Performed" section also lists:

Clinical Testing: "Not required and not performed."
Animal Testing: "Not required and not performed."

Conclusion:

This document describes a 510(k) submission where the device's acceptable performance is proven by demonstrating substantial equivalence to a predicate device through non-clinical testing (biocompatibility, physical/mechanical properties, internal specifications, risk analysis) rather than through a dedicated clinical study with specific performance metrics and a test set of patient data as implied by the questions.

Therefore, most of the questions you asked are not applicable to the information contained within this 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the rest of the name in a sans-serif font.

January 5, 2018

OraMetrix, Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC. 1394 25th Street NW Buffalo, Minnesota 551313

Re: K171860

Trade/Device Name: Sureclear™ aligner system Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: December 27, 2017 Received: December 29, 2017

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 -S

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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Indications for Use

510(k) Number (if known)

Device Name sureclear™ aligners

Indications for Use (Describe)

Sureclear™ aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition.

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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510(k) Summary

OraMetrix sureclear™ aligners

5.1 Submission Sponsor

OraMetrix, Inc.

2350 Campbell Creek Blvd.

Suite 400

Richardson, TX 75082

USA

Phone number: 49-30-24309139

Contact: Sabrina Weitzel

Email: sabrina.weitzel@orametrix.de

5.2 Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road, Bldg. 1, Suite 300

Austin, TX 78746

Office Phone: (512) 327-9997

Contact: Stuart R. Goldman, Senior Consultant, RA

Email: project.management@emergogroup.com

5.3 Date Prepared

May 31, 2017

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5.4 Device Identification

Trade/Proprietary Name:	sureclear™ aligners
Common/Usual Name:	Sequential aligners
Classification Name:	Orthodontic plastic bracket
Regulation Number:	NXC
Product Code:	872.5470
Device Class:	Class II
Classification Panel:	Dental

5.5 Legally Marketed Predicate Device

ClearCorrect System (K113618)

5.6 Device Description

5.7 Indication for Use

Sureclear™ aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition.

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5.8 Substantial Equivalence Discussion

OraMetrix has chosen the ClearCorrect System cleared by the FDA under K113618 as the predicate device for its sureclear™ aligners. The following table compares the subject device to the predicate device with respect to their indications for use, technology and performance testing, thus demonstrating the basis for determination of substantial equivalence between these devices.

Regulatory Information
Device Name	Sureclear™ Aligners	ClearCorrect System	Similarities/Differences
Manufacturer	OraMetrix, Inc.	ClearCorrect, Inc.	na
510(k)	Pending	K113618	na
Product Code	NXC	NXC	Same.
Regulation	§872.5470	§872.5470	Same.
Class	II	II	Same.
Indications forUse	Sureclear™ aligners are indicated forthe treatment of tooth malocclusionin patients with permanent dentition.	The ClearCorrect System is indicated forthe treatment of tooth malocclusion inpatients with permanent dentition (i.e.,all second molars). The ClearCorrectSystem positions teeth by way ofcontinuous gentle force.	Same.
Prescription use	Yes	Yes	Same.
Fundamental Scientific Technology
Device Images	Image: Sureclear Aligners	Image: ClearCorrect Aligners	Similar. Variesby patientprescription.
Conditions ofUse	Worn daily by the patient forapproximately 20 to 22 hours, exceptwhen performing dental hygiene andeating and drinking. The treatmentplan (and time) varies by individualpatient prescription.	Worn daily by the patient forapproximately 20 to 22 hours, exceptwhen performing dental hygiene andeating and drinking. The treatment plan(and time) varies by individual patientprescription.	Same.

Table 5-1 – Comparison of Characteristics

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Mechanism ofAction	Sequential aligners are made fromelastic thermoplastic materials thatapply continuous gentle force to theteeth.	Sequential aligners are made fromelastic thermoplastic materials thatapply continuous gentle force to theteeth.	Same.
Material	Elastic thermoplastic material.	Elastic thermoplastic material.	Similar.
Sizes	Patient specific.	Patient specific.	Same.
Manufacturingmethod	Thermoforming.	Thermoforming.	Similar.
Body Location	Mouth; mucosal membranes.	Mouth; mucosal membranes.	Same.
Relevant Testing Performed
BiocompatibilityTesting	Per ISO 10993-1 and applicable parts.	Per ISO 10993-1 and applicable parts.	Similar.
Animal Testing	Not required and not performed.	Not required and not performed.	Same.
Clinical Testing	Not required and not performed.	Not required and not performed.	Same.
Risk Analysis	Per ISO 14971.	Assumed to have been performed.	Similar.

5.9 Non-Clinical Performance Data

OraMetrix has submitted finished sureclear™ aligners for the appropriate biocompatibility testing per ISO 10993-1 and its applicable parts, while the physical and mechanical properties of the elastic thermoplastic materials used to fabricate the aligners have previously been demonstrated by the manufacturer of the base materials. The subject device meets all internal OraMetrix specification requirements to support substantial equivalence to the predicate device.

5.10 Clinical Performance Data

The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there was no clinical testing required to support sureclear™ aligners, as the indications for use is equivalent to the predicate device, which was not subjected to any clinical testing. The substantial equivalence of the subject device to the ClearCorrect System is supported by the non-clinical testing that was performed, along with other supporting documentation, and presented in this submission.

5.11 Statement of Substantial Equivalence

Sureclear™ aligners have substantially equivalent Indications for Use as the identified predicate device. While the verbiage of the Indications of Use of the subject device is slightly different than the declared predicate; however, these slight differences do not alter the intended therapeutic use of the device as compared to the predicate device. The conclusions drawn from the data included in this submission,

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demonstrate that sureclear™ aligners are as safe, as effective, and are substantially equivalent to the predicate device in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.

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.