The Progressive Orthodontics App is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, which may be used for sequential aligner trays or retainers. These applications are based on 3D scans of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

The use of the Progressive Orthodontics App requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Device Description

The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient's dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment. This is a software only device. Physical outputs such as aligners are not included in the scope of the clearance.

AI/ML Overview

The provided text is a 510(k) summary for the Progressive Orthodontics App. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics against acceptance criteria. Therefore, several requested pieces of information are not explicitly detailed in this type of submission.

Here's an attempt to answer your questions based on the provided text, along with indications where the information is not present:

1. Table of acceptance criteria and reported device performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics in a table. It only states that "All test results met acceptance criteria" (Page 7) and "The software passed the testing and performed per its intended use" (Page 8) after verification and validation.

2. Sample size used for the test set and data provenance

This information is not present in the provided document. The 510(k) summary mentions "integration, verification, and validation testing" (Page 8) but does not detail the size of the dataset used for these tests, nor its provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and their qualifications

This information is not present. The document doesn't describe the process of establishing ground truth for any testing performed.

4. Adjudication method for the test set

This information is not present. No details are provided on how disagreements in ground truth (if experts were involved) were resolved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size

No, a multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or at least not reported in this 510(k) summary. The document focuses on demonstrating substantial equivalence through software verification and validation, not on clinical comparative effectiveness.

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

The document states, "The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients." (Page 4). It further states that "The use of the Progressive Orthodontics App requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software." (Page 5). This strongly implies human-in-the-loop performance, as the software is a "front-end software tool" to assist professionals. While "standalone software module" is listed as a principle of operation (Page 6), this refers to the software existing independently, not necessarily operating without human interpretation or control. No "algorithm only" performance data is presented.

7. The type of ground truth used

The document does not specify the type of ground truth used for any testing. Since the product is a design and simulation tool, not a diagnostic one providing automated interpretations, the concept of "ground truth" for its performance evaluation (e.g., accuracy of measurements, validity of simulations) would likely involve comparison to established orthodontic principles, validated physical models, or expert consensus on design parameters, but this is not detailed.

8. The sample size for the training set

This information is not present. The 510(k) summary does not mention any "training set" for the software, suggesting that if machine learning or AI models are involved, their development and training details were not part of this specific submission summary. The product is described more as a design and simulation tool rather than an AI-driven image analysis or diagnostic tool.

9. How the ground truth for the training set was established

This information is not present, as no training set is mentioned in the document.

Summary

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October 11, 2024

Progressive Aligners Inc. Fouad Alaeddin Chief Financial Officer 135 Columbia Aliso Viejo, California 92656

Re: K241153

Trade/Device Name: Progressive Orthodontics App Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: September 26, 2024 Received: September 27, 2024

Dear Fouad Alaeddin:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT 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

Submission Number (if known)

K241153

Device Name

Progressive Orthodontics App

Indications for Use (Describe)

The Progressive Orthodontics App is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, which may be used for sequential aligner trays or refainers. These applications are based on 3D scans of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

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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K241153

510(k)

510(k) Summary

Submitter:	Progressive Aligners Inc.135 Columbia Ste 101Aliso Viejo, CA 92656
Company Contact Person:	Dr. Collins Harrell, Clinical Director
	Phone: (949) 547-0619
	Email: Collins@posortho.com
Submission Correspondent:	Fouad Alaeddin, CPA, CFO and Regulatory Affairs
	Phone: (949) 468-7951
	Email: Fouad@posortho.com
Date Prepared:	October 10, 2024
Proprietary Name:	Progressive Orthodontics App
Common/Usual Name:	Orthodontic Software
Classification Name:	Orthodontic Plastic Bracket
Product Code:	PNN, LLZ
Device Class:	Medical Device, Class II
Regulation Number:	21 CFR 872.5470
Predicate Device:	Orchestrate 3D Orthodontic Software (K181112)

Device Description:

Predicate Device:

Indication of Use:

The use of the Progressive Orthodontics App reguires the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the Software .

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Comparison to Predicate Device:

The proposed Progressive Orthodontics App has similar indications for use and uses the same fundamental technology as the legally marketed predicate device to which substantial equivalency is claimed, the Orchestrate 3D Orthodontic Software (K181112)

	Predicate DeviceOrchestrate 3D Orthodontic Software	Subject DeviceProgressive_Orthodontics App
	(K181112)	(K241153)
Indication of Use	The Orchestrate 3D Orthodontic Software isindicated for use as a front-end softwaretool for management of orthodontic models,systematic inspection, detailed analysis,treatment simulation and virtual appliancedesign options, including dental casts,which may be used for sequential alignertrays or retainers. These applications arebased on 3D models of the patient'sdentition before the start of an orthodontictreatment. It can also be applied during thetreatment to inspect and analyze theprogress of the treatment. It can be usedat the end of the treatment to evaluate ifthe outcome is consistent with theplanned/desired treatment objectives.The use of the Orchestrate 3D requires theuser to have the necessary training anddomain knowledge in the practice oforthodontics, as well as to have received adedicated training in the use of the software.	The Progressive Orthodontics App isindicated for use as a front-end softwaretool for management of orthodonticmodels, systematic inspection, detailedanalysis, treatment simulation and virtualappliance design options, which may beused for sequential aligner trays orretainers. These applications are based on3D scans of the patient's dentition beforethe start of an orthodontic treatment. Itcan also be applied during the treatmentto inspect and analyze the progress of thetreatment. It can be used at the end of thetreatment to evaluate if the outcome isconsistent with the planned/desiredtreatment objectives.The use of the Progressive Orthodontics Apprequires the user to have the necessarytraining and domain knowledge in thepractice of orthodontics, as well as to havereceived a dedicated training in the use of thesoftware .
	Predicate Device Orchestrate 3DOrthodontic Software(K181112)	Subject DeviceProgressive Orthodontics App(K241153)
Intended Use	• Used by dental professionals inorthodontic treatment planning(before, during and aftertreatment)• Management of patients andmodels• Inspection, measurement andanalysis of orthodontic models• Treatment simulation• Virtual appliance preparation,handling and export• Provides digital file	• Used by dental professionals inorthodontic treatment planning(before, during, and aftertreatment)• Management of patients andmodels• Inspection, measurement, andanalysis of orthodontic models• Treatment simulation• Virtual preparation of dentalappliances• Provides digital file
SoftwareEnvironment of Use	Dental office	Dental office
Software IntendedUser	Dental professional	Dental professional
Intended PatientPopulation	Patients with malocclusion	Patients with malocclusion
Target AnatomicArea	Maxilla, Mandible	Maxilla, Mandible
Type of PatientContact	None	None
Principle ofOperation	• Stand Alone Software Module• Imports Digital Patient Scans• Can be used to design Dental Casts• Useful for Diagnosis,treatment planning, andCAD design• Virtual Planning of toothmovement• Supports STL Files	• Stand Alone Software Module• Imports Digital Patient Scans• Can be used to design Dentalappliances• Useful for Diagnosis,treatment planning, and CADdesign• Virtual Planning of tooth movement• Supports STL Files
Technical attributes	• OS: Windows 10 64-bit• RAM: 8 GB• Monitor resolution: 1280X800• Video Card Memory: 1 GB• Available HDD Space: 10 GB• CPU: Intel compatible 2.6GHz/Dual or Quad core 2.6 GHz• Mouse: Any Mouse withscrolling wheel or button	• OS: Windows 10 64-bit, 11 64-bit• RAM: 10 GB or higher• Monitor Resolution: 1280x800• Video Card Memory: 2 GB• Available HDD Space: 10 GB or more• CPU: IntelCore i5 2.6 GHz• Mouse: Any mouse withscrolling wheel or button
	Predicate DeviceOrchestrate 3D Orthodontic Software(K181112)	New DeviceProgressive Orthodontics App(K241153)
Management ofpatient/case basedata	Allows creating, editing, deleting, copying patient/case data	Allows creating, editing, deleting, copying patient/case data
Collection of Input	• Surface scan for intra-oral scanner• Surface scan from STL file• 2D overlay: PNG, JPG, BMP	• Surface scan for intra-oral scanner• Surface scan from STL or OBJ file• 2D overlay: PNG, JPG, BMP
Alignment of Input	Aligning surface scan image• Alignment of 2D overlays (e.g., ideal arch)	Aligning surface scan image• Alignment of 2D overlays (e.g., ideal arch)
Measurement of	3D measurement toolbox	3D measurement toolbox
Analysis of Input	• Arch shape Occlusion Map• Overjet/overbite	• Arch shape Occlusion Map• Tooth width Overjet/Overbite
Treatmentsimulation	3D simulation	3D simulation
Virtual ApplianceDesign	• Treatment Plans• Dental Casts	• Treatment plans• Appliances designs

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NON-CLINICAL TESTS:

Software and integration verification and validation testing were performed in accordance with the FDA Guidance Document, "Content of Premarket Submissions for Device Software Functions" (issued June 14, 2023) and FDA Guidance Document, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued September 27, 2023)"and IEC 62304 – Software Life Cycle Processes. All test results met acceptance criteria, demonstrating the Progressive Orthodontics software performs as intended, raises no new questions of safety or effectiveness and is substantially equivalent to the predicate device.

CONCLUSION:

Progressive Aligners, Inc. considers the Progressive Orthodontics App to be substantially equivalent to the predicate device.

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Comparison of Indications for Use to Predicate Device:

Based on the above comparison, the indications for use of the Progressive Orthodontics App is similar to that of the Orchestrate 3D Orthodontic Software, except for the dental casts that are not produced by the Progressive Orthodontics App. This difference is not critical to the intended use and does not constitute a new intended use, Therefore, the Progressive Orthodontics App can be considered substantially equivalent to its predicate device.

Comparison of Technological Features to Predicate Device:

Based on the above comparison, the design, construction, and performance characteristics of the Progressive Orthodontics App is similar to that of Orchestrate 3D Orthodontic Software. Therefore, the Progressive Orthodontics App can be considered substantially equivalent to its predicate device.

Summary of Performance Data and Substantial Equivalence:

Utilizing FDA Guidance document "Content of Premarket Submissions for Device Software Functions" (issued June, 14, 2023), and "The 510(k) Program:Evaluating Substantial Equivalence in Premarket Notifications {510(k}} ," the Progressive Orthodontics App underwent appropriate integration, verification, and validation testing. The software passed the testing and performed per its intended use.

Conclusion:

Based on comparison of indications for use, technological features, performance testing, and software verification and validation testing, the Progressive Orthodontics App have been shown to be appropriate for its indications for use and is substantially equivalent to the legally marketed predicate device.

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.