ClearForm Aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusions. The aligners position teeth by way of continuous gentle forces.

Device Description

ClearForm Aligners consist of a series of customized removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force.

A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop an orthodontic treatment plan. Using the software dental technicians produce a series of intermediate digital models corresponding to each stage of treatment, gradually aligning the patient's teeth according to the dental health professional's prescriptions.

The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.

The prescribing doctor reviews and approves the treatment plan before the models/molds are produced.

Once approved, physical models are produced from the digital model files. The aligner trays are formed over the physical models by using thermal forming equipment and a thermoplastic sheet. The aligner trays are sent to the dental health professional who then delivers them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the dental health professional to gradually move the teeth to the desired position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.

AI/ML Overview

This document is a 510(k) Premarket Notification for ClearForm Aligners, an orthodontic device. It provides information for establishing substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device performance study.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (such as acceptance criteria table, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this document. The document describes a comparison to predicate devices, non-clinical performance data (manufacturing validation, material properties, biocompatibility), and states that no clinical performance data was provided.

Here's what can be extracted based on the provided text, while noting the limitations:

Device Name: ClearForm Aligners

Device Type: Orthodontic Plastic Bracket (Class II)

Purpose of this Document: 510(k) Premarket Notification to demonstrate substantial equivalence to legally marketed predicate devices.

Summary of Device Acceptance/Evaluation from this Document:

The acceptance for this device is based on demonstrating substantial equivalence to predicate devices through similarities in indications for use, technology, and non-clinical performance testing.

1. Table of Acceptance Criteria and the Reported Device Performance:

Since this is a 510(k) submission for an orthodontic aligner and not an AI/ML-driven device with specific performance metrics like sensitivity/specificity, a direct "acceptance criteria" table with reported performance in that sense is not present. However, the document outlines "acceptance criteria" for the manufacturing validation.

Acceptance Criteria (from Manufacturing Validation)	Reported Device Performance (from Manufacturing Validation)
Translational measurements within 0.150 microns of the target input value (predefined tolerance).	Translational measurements were within 0.150 microns of the target input value. There were no significant differences in the intended and measured values observed from any of the groups.
Qualitative assessment of device fit meets acceptance criteria.	An additional qualitative assessment of device fit was performed meeting the acceptance criteria.

Note: These are manufacturing process validation criteria, not clinical performance criteria for diagnosis or treatment outcome effectiveness.

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

Test Set Sample Size: Not applicable in the context of an AI/ML performance study. The "test set" here refers to samples used for manufacturing validation. The document states "Three critical aspects of the manufacturing process were assessed for accuracy: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners." The exact number of samples for each aspect is not specified, but it's related to a manufacturing process, not patient data for an algorithm's performance.
Data Provenance: Not applicable in the context of patient data for an algorithm. The data provenance described is from their internal manufacturing validation process.

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

Not applicable. Ground truth for an AI/ML model for diagnostic/prognostic purposes is not established for this device's 510(k) submission. The "ground truth" here is the "target input value" (digital design) for manufacturing accuracy comparison.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication process for diagnostic labels or classifications is described. The "adjudication" for manufacturing validation was likely based on comparison to design specifications.

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

No. The document explicitly states: "Clinical performance data was not provided for ClearForm Aligners." Therefore, no MRMC study or effect size of human readers improving with AI assistance vs. without AI assistance was reported.

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

No. This device is not an AI/ML algorithm. The software mentioned (3Shape A/S Ortho System) is for treatment planning and model creation, and it has its own 510(k) clearance (K180941). The ClearForm Aligners itself is a physical medical device.

7. The Type of Ground Truth Used:

For Manufacturing Validation: The ground truth used was the "target input value," which refers to the digital design specifications derived from the orthodontic treatment plan created using the specialized CAD/CAM software. The accuracy of the manufactured components (digital dentition models, 3D printed molds, thermoformed aligners) was measured against these digital design specifications.
For Substantial Equivalence: The ground truth for this regulatory pathway is the characteristics and safety/effectiveness profile of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm requiring a training set of data.

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

Not applicable. (See #8)

In summary: This 510(k) document is for a physical medical device (orthodontic aligners). The regulatory pathway for this device is primarily based on demonstrating substantial equivalence to existing predicate devices and providing non-clinical performance data related to manufacturing accuracy and material properties. It does not involve a "study that proves the device meets acceptance criteria" in the context of AI/ML algorithm performance on patient data, nor does it present clinical trial data for effectiveness.

Summary

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March 20, 2020

Motor City Lab Works % Chris Brown Manager Aclivi. LLC 6455 Farley Road Pinckney, Michigan 48169

Re: K191838

Trade/Device Name: Clearform Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: February 10, 2020 Received: February 18, 2020

Dear Chris Brown:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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) K191838

Device Name ClearForm Aligners

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)

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K191838 510(k) Summary Motor City Lab Works ClearForm Aligners

ADMINISTRATIVE INFORMATION

Manufacturer Name	Motor City Lab Works2200 Holland StBirmingham, Michigan 48009USA
	Telephone: +1 (248) 250-9519Fax: n/a
Official Contact	Dr. Christian Groth, PresidentTelephone: +1 (248) 250-9519
Email:	Info@motorcitylabworks.com
Date Submitted:	2/10/2020

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	ClearForm Aligners
Common Name:	Aligners, sequential
Classification Name:	Orthodontic Plastic Bracket
Classification Regulations:	21 CFR 872.5470
Device Class:	Class II
Product Code:	NXC
Review Panel:	Dental
Reviewing Branch:	Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)Dental Devices (DHT1B)

PREDICATE DEVICE INFORMATION

The devices within this submission are substantially equivalent in indications, intended use and design principles to the following predicate device:

510(k)	Predicate Device Name	Company Name
K180241	Twin Aligner	Ortho Caps GmbH
Reference Device Name
K180941	Ortho System	3Shape A/S
K062828	Essix	Dentsply

DEVICE DESCRIPTION

ClearForm Aligners consist of a series of customized removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force.

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orthodontic CAD/CAM software is used to develop an orthodontic treatment plan. Using the software dental technicians produce a series of intermediate digital models corresponding to each stage of treatment, gradually aligning the patient's teeth according to the dental health professional's prescriptions.

The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.

The prescribing doctor reviews and approves the treatment plan before the models/molds are produced.

INDICATIONS FOR USE

EQUIVALENCE TO MARKETED DEVICE

The Subject device is highly similar to the Predicate device with respect to Indications for Use and technological principles. Slight differences in the wording of the Indications for Use only changes the intended use of the Subject device to include patients with permanent dentition (i.e all second molars). The Comparison table below compares parameters and characteristics of the subject device and predicate/reference devices.

Parameter	Subject Device	Predicate Device
Regulation #	21 CFR 872.5470	21 CFR 872.5470
DeviceClassificationName	Orthodontic PlasticBracket	Orthodontic PlasticBracket
Product Code	NXC	NXC
Classification	Class II	Class II
Indications for Use	ClearForm Aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusions. The aligners position teeth by way of continuous gentle forces.	The Orthocaps TwinAligner® System is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
Mode of action	Orthodontic movement occurs through continuous gentle forces applied to the dentition as each tooth follows the programmed displacement based on a doctor's prescription.	Orthodontic movement occurs through continuous gentle forces applied to the dentition as each tooth follows the programmed displacement based on a doctor's prescription.
Method of use	Each preformed plastic tray is worn in sequence by the patient as prescribed by the dental practitioner.	Each preformed plastic tray is worn in sequence by the patient as prescribed by the dental practitioner.

Predicate Device Comparison Table

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Parameter	Subject Device	Predicate Device
Function of the software	ClearForm AlignerStandard dental software for tooth alignment usesdigital scan (untreated state) to generate the imageof a final, provisional treated state and theninterprets a series of images that representintermediate teeth states. The dental practitionerthen reviews these images and has the option toreject or request modifications to the set-up prior toapproving it for aligner fabrication. Once the dentalpractitioner approves the treatment plan, thesoftware converts the files to produce the series of3D models used to produce thermoformed aligners.	Ortho Caps Twin AlignerK180241Standard dental software for tooth alignment usesdigital scan (untreated state) to generate the imageof a final, provisional treated state and theninterprets a series of images that representintermediate teeth states. The dental practitionerthen reviews these images and has the option toreject or request modifications to the set-up prior toapproving it for aligner fabrication. Once the dentalpractitioner approves the treatment plan, thesoftware converts the files to produce the series of3D models used to produce thermoformed aligners.
Material	Essix thermoplastic	Thermoplastic
MaterialProperties	Demonstrates sufficient tensile strength, elasticity,ductility, chemical resistance, and clarity for use as aclear tray aligner	Demonstrates sufficient tensile strength, elasticity,ductility, chemical resistance, and clarity for use as aclear tray aligner.
Design	Image: clear aligner	Image: clear aligner
Biocompatible	Yes	Yes
OTC or Rx	Rx	Rx
Sterile	Non-sterile	Non-sterile

TECHNOLOGICAL CHARACTERISTICS

The Subject device mechanism of action is identical to the Predicate device and supports a determination of substantial equivalence. The Subject device use of Software is identical to the Predicate device and supports a determination of substantial equivalence. The Subject and Predicate devices are both fabricated of a non-sterile, biocompatible thermoplastic material which supports a determination of substantial equivalence. The Subject device is fabricated of the Reference device material which is indicated for the intended use.

Non-clinical Performance Data

Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.

Software used for treatment planning and creation of models/casts for ClearForm Aligners is manufactured by 3Shape A/S under the name Ortho System. It has a 510(k) clearance (K180941) under the PNN product code and is indicated for the intended use.

An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for ClearForm Aligners. Three critical aspects of the manufacturing process were assessed for accuracy: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners.

Independent 3rd party reverse engineering/inspection software was used to perform point-to-point and critical displacement measurements.

Translational measurements were within 0.150 microns) of the target input value, the predefined tolerance of the manufacturing process. There were no significant differences in the

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difference in the intended and measured values observed from any of the groups. This test has met the pre-established acceptance criteria to demonstrate dimensional accuracy.

An additional qualitative assessment of device fit was performed meeting the acceptance criteria.

The material used for ClearForm Aligners has a 510(k) clearance (K062828) for use as an aligner material. Biocompatibility testing for the aligner material, the only patient contacting material, has been conducted by the 510(k) holder in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".

Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on the final, finished Subject device.

CLINICAL TESTING

Clinical performance data was not provided for ClearForm Aligners.

CONCLUSION

Based on similarities in Indications for Use and technology, as well as non-clinical performance testing, we believe that ClearForm Aligners are substantially equivalent to the Orthocaps TwinAligner® System.

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.