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 Orchestrate 3D 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 Orchestrate 3D Orthodontic Software is an orthodontic appliance design and treatment simulation software. This software is for use by Dental professionals to diagnose and design solutions for patients. Digital scans (3D) of a patient denture can be loaded into the software and the dental professional can then create treatment plans for each individual patient and their needs. The system can be used to fabricate dental casts using standard stereolithographic (STL) files for use in 3D printers. Dental casts printed can then be used to manufacture sequential aligner trays and retainers.

AI/ML Overview

The provided text describes the "Orchestrate 3D Orthodontic Software," which is an orthodontic appliance design and treatment simulation software. The document is an FDA 510(k) summary demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity). Instead, the performance is demonstrated through a comparative analysis with a predicate device and a general statement about software testing.

Acceptance Criteria Category	Specific Criteria (Implicit/General)	Reported Device Performance
Functional Equivalence	Indicated for similar use cases	"The Orchestrate 3D Orthodontic Software 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..." This is deemed "Similar" to the predicate.
Technological Features	Possesses similar core features and capabilities	"Stand Alone Software Module," "Imports Digital Patient Scans," "Can be used to design Dental Casts," "Useful for Diagnosis, treatment planning, and CAD design," "Virtual Planning of tooth movement," "Supports STL Files." These are deemed "Same" as the predicate.
Hardware/Software Requirements	Compatible with standard computing environments	"OS: Windows 10 64-bit, RAM: 8 GB, Monitor Resolution: 1280 X 800, Video Card Memory: 1 GB, Hard Drive Space: 10 GB, CPU: Intel compatible 2.6 GHz/Dual or Quad core 2.6 GHz, Mouse: Any Mouse with scrolling wheel or button." These are deemed "Same" as the predicate.
Login Method	Secure user access	"None Required; Uses Windows 10 Log in Security for User ID." Deemed "Similar; No effect to the indication for use."
Software Validation/Performance	Software performs per its intended use and passes testing	"The software passed the testing and performed per its intended use."

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

The document does not report any specific sample size for a test set used to evaluate the device's performance in terms of clinical or technical accuracy. The comparison provided is at a feature and functional level with a predicate device.

There is no mention of data provenance (e.g., country of origin, retrospective or prospective) for any test data, as no specific performance study on patient data is detailed.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention any experts or adjudication processes used to establish a ground truth for a test set. The review primarily focuses on software functionality and its comparison to a legally marketed predicate device.

4. Adjudication Method:

Since no test set evaluating clinical performance against a ground truth is described, no adjudication method (e.g., 2+1, 3+1, none) is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not mentioned or presented in the provided text. The document does not discuss human reader performance with or without AI assistance. The software is described as a "front-end software tool" for professionals, implying it aids existing clinical workflows rather than directly replacing or augmenting human diagnostic performance in a quantifiable, comparative manner in this submission.

6. Standalone Performance Study:

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not explicitly described or presented in terms of clinical metrics. The document states that the "software passed the testing and performed per its intended use," but this refers to general software verification and validation, not a standalone clinical performance study on a dataset.

7. Type of Ground Truth Used:

No specific ground truth (expert consensus, pathology, outcomes data, etc.) was mentioned as being used to validate the performance of the Orchestrate 3D Orthodontic Software. The validation presented focuses on functional equivalence to a predicate device and general software testing.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. As a software tool for design and simulation, rather than an AI/ML algorithm that learns from data, the concept of a "training set" in the context of typical AI device submissions may not directly apply or is not detailed here.

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

Since no training set is mentioned, there is no information on how its ground truth might have been established.

In summary, the provided FDA 510(k) summary for Orchestrate 3D focuses on establishing substantial equivalence to a predicate device (3Shape Ortho System) through a comparison of indications for use, technological features, and the results of general software verification and validation testing. It does not contain details about clinical performance studies with specific acceptance criteria, test sets, ground truth establishment, or expert evaluations commonly found in submissions for AI/ML-driven diagnostic devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

Orchestrate 3D % Bill Jacqmein Consultant JCO Consulting 11218 Zest Court NE Blaine, Minnesota 55449

Re: K181112

Trade/Device Name: Orchestrate 3D Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Second Product Code: LLZ Dated: October 17, 2018 Received: October 23, 2018

Dear Bill Jacqmein:

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.

11.26.18

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-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.

Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 07:57:41 -05'00'

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) K181112

Device Name Orchestrate 3D

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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Section 5. 510(k) Summary

K181112

510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter:		Orchestrate 3D1747 North Riverside AveRialto, CA 92376
Company ContactPerson:		Todd Ehrler, DDS, MS
	Phone:Email:	(888) 755.8320Todd.Erhler@orchestrate3d.com
SubmissionCorrespondent:		Bill Jacqmein, Regulatory Affairs Consultant
	Address:Phone:Email:	11218 Zest Ct. NE, Blaine, MN 55449(404) 216-6190bjacqmein@rcqsolutions.com
Date Prepared:		October 17, 2018
Proprietary Name:		Orchestrate 3D Orthodontic Software
Common Name:		Orthodontic Plastic Brackets (Software)
Product Code:		PNN – Orthodontic Plastic Brackets, LLZ – System, ImageProcessing, Radiological
Device Classification:		Class II, 21 CFR 872.5470
Primary PredicateDevices:		3Shape Ortho System (K171634)

Device Description:

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Indications for Use:

The Orchestrate 3D Orthodontic Software 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, including dental casts, which may be used for sequential aligner trays or retainers. These applications are based on 3D models 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.

Comparison to Predicate Devices:

Orchestrate 3D Orthodontic Software is functionally equivalent to the following predicate device: 3Shape Ortho System (K171634) cleared January 17th, 2018).

The following table demonstrates the functional specifications of Orchestrate 3D Orthodontic Software are substantially equivalent to the predicate devices.

Specification	Orchestrate 3D Orthodontic Software	3Shape Ortho System (K171634)	ComparisonResult
Indication forUse	The Orchestrate 3D Orthodontic Software 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, including dental casts, which may be used for sequential aligner trays or retainers. These applications are based on 3D models 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 Orchestrate 3D requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have	The 3Shape Ortho System™ is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Custom Metal Bands, Export of Models, Indirect Bonding Transfer Media) based on 3D models 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 Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have	Similar

Table 1: Functional Specification Comparison

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	received a dedicated training in theuse of the software.	received a dedicated training in theuse of the software.
TechnologyFeatures	Stand Alone Software Module Imports Digital Patient Scans Can be used to design Dental Casts Useful for Diagnosis, treatment planning, and CAD design Virtual Planning of tooth movement Supports STL Files	Stand Alone Software Module Imports Digital Patient Scans Can be used to design Dental Casts Useful for Diagnosis, treatment planning, and CAD design Virtual Planning of tooth movement Supports STL Files	Same
MinimumHardware/SoftwareRequirements	OS: Windows 10 64-bit RAM: 8 GB Monitor Resolution: 1280 X 800 Video Card Memory: 1 GB Hard Drive Space: 10 GB CPU: Intel compatible 2.6 GHz/Dual or Quad core 2.6 GHz Mouse: Any Mouse with scrolling wheel or button	OS: Windows 7, 8, 10 64-bit RAM: 8 GB Monitor Resolution: 1280 X 800 Video Card Memory: 1 GB Hard Drive Space: 10 GB CPU: Intel Core i5 or equivalent Mouse: with wheel button	Same
Login Method	None Required; Uses Windows 10Log in Security for User ID	Username and Password	Similar; No effect to theindication for use

Feature Comparison	Orchestrate 3D	3Shape (K171634)
Supported anatomicareas	Maxilla/Mandible	Maxilla/Mandible
Intended Use
Managing Patient andcase base data	Yes	Yes
Collection of studymaterial	Yes	Yes
Alignment of studymaterial	Yes	Yes
Measuring studymaterial	Yes	Yes
Analyzing StudyMaterial	Yes	Yes
Treatment Simulation	Yes	Yes
Virtual ApplianceDesign	Yes	Yes
Supported PC formats	Windows	Windows
Managing patient and case base data
Creating, editing,deleting and copyingpatient data	Yes	Yes
Creating, editing,deleting and copyingcase data	Yes	Yes
Collection of study material
Surface scan for	intraoral scanner	Yes	Yes
Surface scan from STLfile		Yes	Yes
CT image data(DICOM)		No	Yes
2D overlay (PNG, JPG,BMP)		No	Yes
Alignment of study material
Aligning surface scanand CT image		No	Yes
Aligning CephalometricImages		No	Yes
Alignment of 2Doverlays		No	Yes
Ability to check/adjustDICOM visibility		No	Yes
DICOM scanSegmentation		No	No
2D Measurement toolbox		No	Yes
3D Measurement toolbox		No	Yes
Analyzing study material
Arch shape		Yes	Yes
Wire length		No	Yes
Tooth width		No	Yes
Bolton		No	Yes
Space Analysis		No	Yes
Overjet/Overbite		Yes	Yes
Occlusion Map		Yes	Yes
Treatment Simulation
2D		No	Yes
3D		Yes	Yes
Virtual Appliance Design
Orthodontic ApplianceSearch		No	Yes
Orthodontic ApplianceVirtual Preparation		Yes	Yes
Orthodontic ApplianceDesign		Yes	Yes
Orthodontic applianceExport		Yes	Yes

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Comparison of Indications for Use to Predicate Devices:

Based on the above comparison, the indications for use of the Orchestrate 3D Orthodontic Software is similar to that of the 3Shape Software. The Orchestrate 3D Orthodontic Software can be considered substantially equivalent to its predicate device.

Comparison of Technological Features to Predicate Devices:

Based on the above comparison, the design, construction, and performance characteristics of the

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Orchestrate 3D Orthodontic Software is similar to that of 3Shape Software. Therefore, the Orchestrate 3D Orthodontic Software can be considered substantially equivalent to its predicate devices.

Summary of Performance Data and Substantial Equivalence:

Utilizing FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2015), the Orchestrate 3D Orthodontic Software underwent appropriate integration, verification 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 validation testing, the Orchestrate 3D Orthodontic Software 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.