MTM® Clear Aligner is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements, MTM® Clear Aligner sequentially positions teeth by way of continuous gentle force.

Device Description

MTM® Clear Aligner consists of a series of custom made removable plastic orthodontic appliances that sequentially positions teeth by way of continuous gentle force.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (MTM® Clear Aligner) and does not contain the information required to answer your request about acceptance criteria and a study that proves the device meets those criteria.

Here's a breakdown of why and what the document does include:

Type of Document: This is an FDA 510(k) clearance letter and summary. It's a regulatory document demonstrating that a new device is "substantially equivalent" to an existing, legally marketed device (predicate device).
Focus of 510(k): The primary goal of a 510(k) is to prove equivalence, not to establish new performance acceptance criteria or conduct new, exhaustive efficacy studies. It often relies on previously cleared devices and existing scientific literature.
Information Absent:
- Acceptance Criteria Table: No such table is present. The document focuses on comparing the proposed device's characteristics and intended use to predicate devices.
- Reported Device Performance: While it discusses the device's function (sequentially positions teeth by continuous gentle force), it doesn't provide specific quantitative performance metrics (e.g., accuracy of movement, patient satisfaction rates, failure rates) against defined acceptance criteria.
- Sample Size for Test Set/Data Provenance: No new test set data is provided, so these details are absent.
- Experts for Ground Truth/Qualifications: Not applicable, as there's no new study generating ground truth for a test set.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No such study is mentioned or reported. The document does not discuss human reader performance with or without AI.
- Standalone Performance Study: No new standalone (algorithm-only) performance study is reported.
- Type of Ground Truth: Not applicable for new data. The "ground truth" for the 510(k) is essentially the established safety and effectiveness of the predicate devices and existing scientific literature.
- Training Set Sample Size/Ground Truth Establishment for Training Set: Not applicable. This document is not about an AI/ML algorithm development or validation.

What the document does say about performance data:

Non-Clinical Performance Data: "No additional non-clinical bench testing has been included in this submission. Nonclinical data was previously submitted and reviewed to support clearance of the primary predicate MTM® Clear Aligner under premarket notification K132145." (Section 7)
Clinical Performance Data: "No new human clinical data has been included in this submission; however a literature review was conducted. Clinical data was previously submitted and reviewed to support clearance of the primary predicate MTM® Clear Aligner under premarket notification K132145, as well as in a prior submission for the MTM® Clear Aligner In-Office system under premarket notification K123925. This data demonstrated performance of the predicate MTM® Clear Aligner for sequential minor incremental tooth movements using Raintree Essix plastics with force point technology. A literature review was conducted in support of the proposed device modification. The literature review is included in this submission to provide valid scientific evidence for intrusive and extrusive orthodontic tooth movements achieved with clear aligner therapy." (Section 8)

In summary, this document does not contain the specific information you requested regarding acceptance criteria and a study proving those criteria are met for the device. It's a regulatory filing based on substantial equivalence to previously cleared devices and a literature review, not a new performance study with defined criteria.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 3, 2017

Dentsply Sirona Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60 York, Pennsylvania 17408

Re: K163155

Trade/Device Name: MTM Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 9, 2016 Received: November 10, 2016

Dear Helen Lewis:

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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K163155

Device Name

MTM® Clear 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)
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Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

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510(k) SUMMARY for MTM® Clear Aligner (K163155)

Submitter Information: 1.

Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

Contact Person:	Helen Lewis
Telephone Number:	717-487-1332
Fax Number:	717-849-4343

Date Prepared: 19 January 2017

2. Device Name:

MTM® Clear Aligner Proprietary Name: ●
Classification Name: Aligner, Sequential ●
CFR Number: 872.5470 ●
Device Class: . II
Product Code: NXC ●

3. Predicate Devices:

Predicate Device Name	510(k)	Company Name
MTM® Clear Aligner	K132145	Raintree Essix Inc.
ClearPath Aligner	K123514	ClearPath Orthodontics

4. Description of Device:

MTM® Clear Aligner consists of a series of custom made removable plastic orthodontic appliances that sequentially positions teeth by way of continuous gentle force.

న. Indications for Use:

Indications for Use Comparison:

In this submission we focus on removing mention of specific movement types from the indications for use statement of the primary predicate. The indications for use are similar between the primary predicate MTM® Clear Aligner and the proposed MTM® Clear Aligner with expanded indications. Both devices are indicated for the correction of anterior tooth misalignments (malocclusions) in

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patients with permanent teeth, using a series of aligners. The primary predicate specifies that four types of tooth movement are used, whereas the proposed MTM® Clear Aligner removes the specific tooth movement types from the indications for use statement, to allow all types of tooth movement to be used.

The indications for use are fundamentally the same between the reference predicate, ClearPath Aligner and the proposed MTM® Clear Aligner. Both devices are indicated for the correction of anterior tooth misalignments (malocclusions) in patients with permanent teeth, using a series of aligners. Neither of them specify the types of tooth movement to be used.

The change in the indications for use to remove specific tooth movement types for the proposed MTM® Clear Aligner does not result in a new intended use for the current, primary predicate MTM® Clear Aligner. This change does not raise new concerns as evidenced in the scientific literature reviewed.

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6. Substantial Equivalence:

Table 5.1 Device Comparison Table

Element	Proposed Device	Primary Predicate	Reference Predicate	Comparison
510(k)	K163155	K132145	K123514	N/A
Device Name	MTM® Clear Aligner	MTM® Clear Aligner	ClearPath Aligner	N/A
Manufacturer	Raintree Essix Inc.	Raintree Essix Inc.	ClearPath Orthodontics	N/A
Intended Use	Treatment of anterior toothmalocclusions in patients withpermanent dentition	Treatment of anterior toothmalocclusions in patients withpermanent dentition	Correction of dental malocclusionin patients with permanentdentition	Same
Indications forUse	MTM® Clear Aligner is indicatedfor the treatment of anterior toothmalocclusions in patients withpermanent dentition (i.e. all secondmolars). Utilizing a series ofincremental minor toothmovements, MTM® Clear Alignersequentially positions teeth by wayof continuous gentle force.	MTM® Clear Aligner is indicated forthe treatment of anterior toothmalocclusions in patients withpermanent dentition (i.e. all secondmolars). Utilizing a series ofincremental minor tooth movements(torque, tipping, rotation and bodilymovement), MTM® Clear Alignersequentially positions teeth by way ofcontinuous gentle force.	The ClearPath Aligner is a seriesof clear, lightweight, plasticappliances indicated for thecorrection of dental malocclusionin patients with permanentdentition (i.e. all second molars).The ClearPath Aligner is intendedfor minor anterior tooth movementby way of continuous gentle force.	Same as referencepredicate. Removingspecific movement typesfrom primary predicateIFU statement.
ToothMovementTypes	All	All except intrusion and extrusion.	All	Same as referencepredicate. Removingspecific movement typesfrom primary predicateIFU statement to allowfor intrusive and extrusivemovements.
Material	Co-polyester or Co-polymer	Co-polyester or Co-polymer	Co-Polyester	Same
Mode ofAction	Continuous gentle force applied toteeth to achieve movement.	Continuous gentle force applied to teethto achieve movement.	Continuous gentle force applied toteeth to achieve movement.	Same
Features	Sequential thermoformed plasticaligners used in the alignment ofteeth by application of continuousgentle force. Aligners can beremoved by the patient for eatingand cleaning. Aligners are mosteffective when worn 20-22 hoursper day.	Sequential thermoformed plasticaligners used in the alignment of teethby application of continuous gentleforce. Aligners can be removed by thepatient for eating and cleaning. Alignersare most effective when worn 20-22hours per day.	Sequential thermoformed plasticaligners used in the alignment ofteeth by application of continuousgentle force. Aligners can beremoved by the patient for eatingand cleaning. Aligners are mosteffective when worn 20-22 hoursper day.	Same

The technological characteristics of the proposed MTM® Clear Aligner are unchanged from those of the primary predicate MTM® Clear Aligner device cleared under premarket notification K132145.

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7. Non-Clinical Performance Data

No additional non-clinical bench testing has been included in this submission. Nonclinical data was previously submitted and reviewed to support clearance of the primary predicate MTM® Clear Aligner under premarket notification K132145.

8. Clinical Performance Data

No new human clinical data has been included in this submission: however a literature review was conducted. Clinical data was previously submitted and reviewed to support clearance of the primary predicate MTM® Clear Aligner under premarket notification K132145, as well as in a prior submission for the MTM® Clear Aligner In-Office system under premarket notification K123925. This data demonstrated performance of the predicate MTM® Clear Aligner for sequential minor incremental tooth movements using Raintree Essix plastics with force point technology. A literature review was conducted in support of the proposed device modification. The literature review is included in this submission to provide valid scientific evidence for intrusive and extrusive orthodontic tooth movements achieved with clear aligner therapy.

9. Conclusion Regarding Substantial Equivalence

The data submitted for non-clinical and clinical performance testing, as well as the technological characteristics of the proposed MTM® Clear Aligner device support substantial equivalence when compared to the 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.