The Aerodentis System is an orthodontic system intended to adjust the patient's teeth through movement from their initial position to the desired position as a result of pulsatile mechanical force. The device is designed to achieve orthodontic tooth movement over a period of approximately 10 hours per day (typically at night). The device is suitable for patients with full complement of permanent teeth in need of upper, lower or combined jaw treatments. The system is composed of two primary components: A custom-made, latex-free, plastic dental mouthpiece is inserted and worn by the patient according to a customized treatment prescription specified by the dental practitioner. The Personal Treatment Controller (PTC), which provides compressed air to the mouthpiece via a polyurethane tube.

AI/ML Overview

The provided document describes the Aerodentis System, an orthodontic device for teeth movement. However, it does not contain specific acceptance criteria or an explicit study that proves the device meets such criteria as typically found in a standalone performance study with quantifiable metrics.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Invisalign System and Acceledent Aura) for FDA 510(k) clearance. This means the device is compared to legally marketed devices based on technological characteristics and performance, rather than against predefined, quantitative acceptance criteria for a novel device.

The "Performance Data" section describes a clinical trial for safety and efficacy, but the results are presented in a comparative and qualitative manner, not against pre-specified numerical thresholds.

Given the information in the provided text, I will construct an answer that reinterprets "acceptance criteria" as the outcomes and findings from the clinical trial and performance testing described, as these are the "criteria" used to support substantial equivalence.

Acceptance Criteria and Device Performance for the Aerodentis System

The provided FDA 510(k) submission for the Aerodentis System does not explicitly state precise, quantifiable acceptance criteria in the format typically used for performance studies establishing specific statistical thresholds. Instead, the submission relies on demonstrating substantial equivalence to predicate devices by showing that the Aerodentis System is as safe and effective. The "acceptance criteria" can therefore be inferred from the outcomes presented in the clinical trial and performance data, which are compared to the performance characteristics expected of similar legally marketed devices.

The clinical trial aimed to demonstrate safety (absence of adverse events and significant root resorption) and efficacy (achieving an average Little's Irregularity Index (LII) of 1.5 or less), as compared to the Invisalign control.

1. Table of "Acceptance Criteria" (Inferred from Study Outcomes) and Reported Device Performance

"Acceptance Criteria" (Inferred from Clinical Study Goals)	Reported Device Performance (Aerodentis System)
Safety:
- Absence of adverse events	No adverse events reported.
- No clinically significant root resorption	No clinically significant root resorption observed.
Efficacy:
- Achieve average Little's Irregularity Index (LII) of 1.5 or less	All subjects who completed treatment achieved an average LII score of 1.5 or less.
Comparative Performance (vs. Invisalign control):
- Safe as the predicate device	Excellent safety profile, similar to predicate.
- Effective in achieving tooth alignment	Effective in achieving an LII of 1.5 or less.
- Potentially higher rates of tooth movement (when accounting for actual use hours)	Statistically significantly higher rates of tooth movement when accounting for actual hours of device use.

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

Sample Size:
- Investigational Arm (Aerodentis System): 28 subjects enrolled, 5 dropped = 23 subjects completed.
- Control Arm (Invisalign): 15 subjects enrolled, 2 dropped = 13 subjects completed.
- Total completed subjects: 36 subjects.
Data Provenance:
- Country of Origin: Not explicitly stated, but the submitter (Dror Orthodesign, Inc.) is located in Jerusalem, Israel, suggesting the study may have been conducted there or internationally.
- Retrospective or Prospective: Prospective. It was a "single center, controlled, clinical trial" where subjects were "followed until" specific endpoints, indicating a prospective study design.

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

The document does not specify the number or qualifications of experts involved in establishing the "ground truth" (e.g., LII scoring). The LII is an objective measurement index, likely applied by trained personnel. However, the document does not detail this specific aspect of the study.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating outcomes. The Little's Irregularity Index is a quantitative measure, and adverse events/root resorption evaluation would typically follow standard clinical assessment protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No background AI assistance/AI-based interpretation. This device is an orthodontic treatment system, not an AI-assisted diagnostic or interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable to this device. The clinical trial compared the device itself to a predicate device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The Aerodentis System is a physical medical device (mouthpiece and controller) used for orthodontic treatment involving a patient and clinical oversight, not a standalone algorithm. The "software validation" mentioned refers to the software controlling the device and developing patient-specific plans, not a standalone diagnostic algorithm for assessment.

7. The Type of Ground Truth Used

Clinical Measurements and Observations:
- Efficacy: The primary efficacy "ground truth" was the average Little's Irregularity Index (LII) score of 1.5 or less. LII is an objective measurement of incisor alignment.
- Safety: Adverse event reporting and radiographic assessment of root resorption served as the safety ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is an orthodontic treatment system, and the provided document describes a clinical trial for its safety and effectiveness, not the development or training of an AI algorithm from a training set of data.

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

Not applicable, as there is no "training set" or "ground truth for a training set" discussed in the context of AI model development for this device. The study described is a clinical trial to evaluate the device itself.

Summary

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May 6, 2020

Dror Orthodesign % Janice Hogan Partner Hogan Lovelle US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K192069

Trade/Device Name: Aerodentis System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: April 10, 2020 Received: April 10, 2020

Dear Ms. Janice Hogan:

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.

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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) 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 Ouality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K192069

Device Name

Aerodentis System

Indications for Use (Describe)

The Aerodentis System is indicated for use in movement of teeth during orthodontic treatment of malocclusion.

Type of Use (Select one or both, as applicable)区 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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K192069 510(k) SUMMARY Aerodentis System

Submitter

Dror Orthodesign, Inc. 7 Hartom St., Mount Hotzvim Jerusalem, Israel 9777507

Phone: +972 74 700 6700 Facsimile: +972 74 700 6767

Contact Person: Michael Nadav

Date Prepared: May 4, 2020

Name of Device:

Aerodentis System

Common or Usual Name:

Sequential Aligner

Classification Name:

872.5470 Orthodontic plastic bracket

Regulatory Class:

Class II

Product Code:

NXC

Primary Predicate:

K181739 Align Technology, Inc.'s Invisalign System

Reference Device:

K130643 Orthoaccel Technologies, Inc.'s Acceledent

Device Description:

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hours per day (typically at night). The device is suitable for patients with full complement of permanent teeth in need of upper, lower or combined jaw treatments.

The system is composed of two primary components:

. A custom-made, latex-free, plastic dental mouthpiece is inserted and worn by the patient according to a customized treatment prescription specified by the dental practitioner.
. The Personal Treatment Controller (PTC), which provides compressed air to the mouthpiece via a polyurethane tube

Indications for Use:

The Aerodentis System is indicated for use in movement and alignment of teeth during orthodontic treatment of malocclusion.

Summary of Technological Characteristics:

	Dror OrthodesignAerodentis System(K192069)	Align Technology, Inc.Invisalign System(K181739)	OrthoaccelTechnologies, Inc.Acceledent Aura(K130643)
Indications forUse	The Aerodentis System isindicated for use inmovement and alignment ofpermanent teeth duringorthodontic treatment ofmalocclusion.	The Invisalign System isindicated for theorthodontic treatment ofmalocclusion.	AcceleDent® Aura isintended for useduring orthodontictreatment. It is usedin conjunction withorthodonticappliances such asbraces and helpsfacilitate minoranterior toothmovement.
UserPopulation	The Aerodentis System issuitable for adults andpediatric patients with fullcomplement of permanentteeth. It is suitable for Class1 and 2 malocclusions,including crowding,proclination andretroclination. The followingmovements are supported:tipping and uprighting ofanterior teeth, and rotation ofincisors.	The Invisalign System issuitable for adults andpediatric patients with fullcomplement of permanentteeth. It is suitable for Class 1and 2 malocclusions,including crowding,proclination andretroclination. The followingmovements are supported:tipping and uprighting ofanterior teeth and rotation ofincisors.	AcceleDent® Aura is anorthodontic accessoryfor the treatment oftooth malocclusion. It isused as an adjunctivetherapy for patientswith orthodonticappliances such asbraces to help facilitatetooth movement.
Components	Mouthpiece andPersonalized TreatmentController	Incremental sets ofaligners	Activator,Mouthpiece andTravel Case

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Principles ofOperation	Inflation of the balloon withinthe Mouthpiece providespressure to the malpositionedteeth to move them into thedesired position over time.	Incremental set of alignersprovides pressure to themalpositioned teeth to movethem into the desired positionover time.	Uses soft pulsetechnology and cyclicforces to accelerate themovement of teeth
PressureApplication	Pulsatile	Constant	Pulsatile
Daily TreatmentLength	8 - 14 hr/day	24 hr/day	20 minutes per dayduring Orthodontictreatment
Software	Yes; used to develop apatient-specific plan andcontrol treatment delivery.	Yes; used to develop apatient specific plan.	Not Applicable

Performance Data:

The following testing was performed to establish equivalence:

. Balloon leak and fatigue testing
Aerodentis System force analysis .
. FEA to support use life
. Biocompatibility testing per ISO 10993-3, -5 and -10
. Software validation per FDA guidance
IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11 testing

A single center, controlled, clinical trial was conducted comparing the investigational Aerodentis System to the Invisalign control. 28 subjects were enrolled in the investigational arm and 15 in the control. 7 subjects dropped from the study (5 from the investigational arm, and 2 from the control). Subjects were followed until the average score of the mandibular and maxillary teeth achieved a Little's Irregularity Index (LII) of 1.5 or less or until 15 months of treatment, whichever came first. Safety was assessed by recording adverse events and radiographic assessment of root resorption. Efficacy was assessed by achieving an average LII score of 1.5 or less.

There were no adverse events reported throughout the study for either treatment arm. In addition, no clinically significant root resorption was observed for either group. Thus, both devices have excellent safety profiles. All subjects that completed treatment achieved an average LII score of 1.5 or less. While the time to treatment until success was longer for the subject device, once accounting for actual hours of device use, the Aerodentis System provided statistically significantly higher rates of tooth movement. This allows the user to achieve tooth alignment while being free of all appliances during normal working hours.

Conclusion:

The Aerodentis System is substantially equivalent to the Invisalign 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.