The ArchForm Orthodontic Software System 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 treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

The use of the ArchForm Orthodontic Software System requires 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 ArchForm Orthodontic Software System 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's dentition 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 FDA document for the ArchForm Orthodontic Software System (K213916) describes its acceptance criteria implicitly through comparison with a predicate device and states that the software underwent performance testing. However, it does not contain specific quantitative acceptance criteria or detailed results of a study that proves the device meets those criteria.

Instead, the document primarily focuses on establishing "substantial equivalence" to a predicate device, the Orchestrate 3D Orthodontic Software (K181112). It asserts equivalence based on indications for use, technological features, and the successful completion of verification and validation testing as per FDA guidance for software in medical devices.

Therefore, many of the requested details about acceptance criteria metrics, sample sizes, expert qualifications, and study design for performance evaluation are not explicitly provided in the given text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Equivalence and Software Testing Success)
The direct "acceptance criteria" for metrics like accuracy, precision, sensitivity, or specificity are not explicitly stated in the provided document. The document implies that the device is acceptable if its functional characteristics and performance are comparable to the predicate device and if it passes software verification and validation testing.

Reported Device Performance
The document states: "The software passed the testing and performed per its intended use." No specific quantitative performance metrics (e.g., accuracy percentages, error margins, etc.) from this testing are reported in the provided text.

Based on the comparison table (pages 5-6), the "performance" is primarily described in terms of functional and technological similarity to the predicate device.

Characteristic	ArchForm Orthodontic Software System Performance (as reported)	Acceptance Criteria (Implied/Predicate Match)
Overall Performance	"The software passed the testing and performed per its intended use."	Device functions as intended and is "substantially equivalent" to predicate device (Orchestrate 3D Orthodontic Software - K181112) in terms of indications for use, technological features, and capabilities for orthodontic model management, inspection, analysis, treatment simulation, and virtual appliance design based on 3D dental models.
Functional Equivalence to Predicate	Same as Orchestrate 3D Orthodontic Software for: indications for use, device class, regulation number, product code, technological features (stand-alone software, imports digital scans, designs dental casts, useful for diagnosis, treatment planning, CAD design, virtual planning of tooth movement, supports STL files), supported anatomic areas (Maxilla/Mandible), managing patient/case base data, collection of study material, alignment of study material, measuring study material, analyzing study material, treatment simulation, virtual appliance design, surface scan for intraoral scanner, surface scan from STL file, Arch Shape analysis, Overbite/Overjet analysis, Occlusal Map, 3D Treatment Simulation, Orthodontic Appliance Virtual Preparation, Orthodontic Appliance Design, Orthodontic Appliance Export.	Must be substantially equivalent in indications for use and technological features to Orchestrate 3D Orthodontic Software (K181112). This includes having the same functional capabilities for orthodontic model management, systematic inspection, detailed analysis, treatment simulation, and virtual appliance design options (including dental casts for aligner trays or retainers) based on 3D dental models before, during, and after orthodontic treatment.
Software Verification & Validation (V&V)	Underwent "appropriate integration, verification, and validation testing" per FDA Guidance, and "passed the testing."	Software components and overall system meet specified requirements and perform reliably and safely for the intended use. (Specific V&V criteria are not detailed in this public summary.)
Minimum Hardware/Software Requirements Compatibility	Compatible with OS: Windows 10 and MacOS Catalina; RAM: 4 GB; Monitor Resolution: 1280 X 720; Video Card: HD620; Hard Drive Space: 128 GB; CPU: Intel 2nd Gen Core i5 or equivalent; Mouse: with wheel button.	Must specify and be compatible with standard hardware and software environments suitable for clinical use, and where possible, match or exceed predicate device requirements (predicate required 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 compatible 2.6 GHz/Dual or Quad Core 2.6 GHz). Note: ArchForm's minimum RAM and Video Card Memory appear lower than the predicate, but this is compared as "Same" in the table.

Study Details

The provided document refers to "appropriate integration, verification, and validation testing" as the study that proves the device meets (implied) acceptance criteria. However, it lacks granular details about this study.

Here's what can be answered and what information is missing:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document does not provide a number of dental models or patient cases used for testing.
- Data Provenance: Not specified. There is no information about the country of origin of the data or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only states that the software's use "requires the user to have the necessary training and domain knowledge in the practice of orthodontics." It does not clarify if orthodontic experts were involved in establishing ground truth for testing, or if so, their specific qualifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The document does not describe any adjudication methods used for establishing ground truth or evaluating the software's performance against a reference.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done or reported. The document describes the device as a "front-end software tool" for orthodontists, implying human-in-the-loop use, but it does not present any study results on human performance with or without the software's assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies that "appropriate integration, verification, and validation testing" was performed on the software itself to ensure it "performed per its intended use." This likely refers to standalone functional and performance testing of the algorithms. However, no specific quantitative results from such a standalone performance study are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly specified. Given the nature of the software (orthodontic treatment simulation and appliance design), ground truth for its internal testing would likely involve comparisons against:
  - Pre-defined anatomical landmarks and measurements.
  - Expected tooth movements and arch forms according to orthodontic principles.
  - Reference 3D dental models or simulations.
  - Expert assessment of simulated treatment plans.
  - However, the document does not detail how this ground truth was established.
The sample size for the training set:
- Not specified. The document does not provide any information about a training set, suggesting that if machine learning is involved, details were not included in this summary, or the software relies on rule-based or deterministic algorithms rather than trainable models.
How the ground truth for the training set was established:
- Not applicable / Not specified, as no training set information is provided.

Summary

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December 16, 2021

ArchForm, Inc % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K213916

Trade/Device Name: ArchForm Orthodontic Software System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: December 13, 2021 Received: December 15, 2021

Dear Dave Yungvirt:

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

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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,

Michael E. Adjodha, M.ChE. Assistant 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) K213916

Device Name ArchForm Orthodontic Software System

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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Submitter: ArchForm, Inc.

K213916

510(k) Summary

ArchForm Orthdontic Software System

Submitter:	ArchForm,Inc.8421 Blue Heron DriveBakersfield, CA 93312
Contact Person:	Andrew S. MartzPhone: 661-304-8575andrew@archform.co
Date Prepared:	December 10, 2021
Trade Name:	ArchForm Orthodontic Software System
Classification Name:	Orthodontic Plastic Brackets (Software)
Device Class:	Class II
Regulation Number:	21 CFR 872.5470
Product Code:	PNN
Review Panel:	Dental
Predicate Device:	Orchestrate 3D Orthodontic Software - K181112
Device Description:	The ArchForm Orthodontic Software System is an orthodonticappliance design and treatment simulation software. This softwareis for use by Dental professionals to diagnose and design solutionsfor patients. Digital scans (3D) of a patient's dentition can be loadedinto the software and the dental professional can then createtreatment plans for each individual patient and their needs. Thesystem can be used to fabricate dental casts using standardstereolithographic (STL) files for use in 3D printers. Dental castsprinted can then be used to manufacture sequential aligner traysand retainers.
Indications for Use:	The ArchForm Orthodontic Software System is indicated for use asa front-end software tool for management of orthodontic models,systematic inspection, detailed analysis, treatment simulation and
Submitter:ArchForm, Inc.	ArchForm Orthodontic Software SystemPremarket Notification: Traditional 510(k)
	of an orthodontic treatment. It can also be applied during thetreatment to inspect and analyze the progress of the treatment. Itcan be used at the end of the treatment to evaluate if the outcomeis consistent with the planned/desired treatment objectives.
	The use of the ArchForm Orthodontic Software System requires theuser to have the necessary training and domain knowledge in thepractice of orthodontics, as well as to have received a dedicatedtraining in the use of the software.
Substantial EquivalenceDiscussion:	The ArchForm Orthodontic Software System is functionallyequivalent to the Orchestrate 3D Orthodontic Software predicatedevice (K181112) cleared November 26, 2018). The followingtable demonstrates that the functional characteristics of theArchForm Orthodontic Software System are substantiallyequivalent to the predicate device.
Comparison of Indications for	Use to Predicate Device: Based on the comparison below, the indications for use of theArchForm Orthodontic Software System is similar to that of theOrchestrate 3D Orthodontic Software. Therefore, the ArchFormOrthodontic Software System can be considered substantiallyequivalent to its predicate device.
Comparison of Technological Featuresto Predicate Device:	Based on the comparison below, the design, construction, andperformance characteristics of the ArchForm Orthodontic SoftwareSystem is similar to that of Orchestrate 3D Orthodontic Software.Therefore, the ArchForm Orthodontic Software System can beconsidered substantially equivalent to its predicate device.
Summary of Performance Data and	Substantial Equivalence: Utilizing FDA Guidance document "Guidance for the Content ofPremarket Submissions for Software Contained in MedicalDevices" (issued May 11, 2005), the ArchForm Orthodontic

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Software System underwent appropriate integration, verification,
and validation testing. The software passed the testing and performed per its intended use.

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Substantial Equivalence Comparison

Characteristic	ArchForm Orthodontic Software System	Orchestrate 3D Orthodontic Software	Comparison
510(k) Number	TBD (K213916)	K181112	N/A
Class	Class II	Class II	Same
DeviceClassificationName	Orthodontic Plastic Brackets (Software)	Orthodontic Plastic Brackets (Software)	Same
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470	Same
Product Code	PNN	PNN	Same
Indications forUse	...is indicated 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, whichmay be used for sequential aligner trays orretainers. These applications are based on3D models of the patient's dentition beforethe start of an orthodontic treatment. It canalso be applied during the treatment toinspect 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 ArchForm OrthodonticSoftware System requires the user to havethe necessary training and domainknowledge in the practice of orthodontics, aswell as to have received a dedicated trainingin the use of the software.	...is indicated 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, whichmay be used for sequential aligner trays orretainers. These applications are based on3D models of the patient's dentition beforethe start of an orthodontic treatment. It canalso be applied during the treatment toinspect 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 Orchestrate 3D OrthodonticSoftware System requires the user to havethe necessary training and domainknowledge in the practice of orthodontics,as well as to have received a dedicatedtraining in the use of the software.	Same
TechnologicalFeatures	Stand Alone Software 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 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
Characteristic	ArchForm Orthodontic Software System	Orchestrate 3D Orthodontic Software	Comparison
MinimumHardware /SoftwareRequirements	OS: Windows 10 and MacOS Catalina RAM: 4 GB Monitor Resolution: 1280 X 720 Video Card: HD620 Hard Drive Space: 128 GB CPU: Intel 2nd Gen Core i5 processor or equivalent Mouse: with wheel 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 compatible 2.6 GHz/Dual or Quad Core 2.6 GHz Mouse: with scrolling wheel or button*	Same
SupportedAnatomicAreas	Maxilla/Mandible	Maxilla/Mandible	Same
Intended UseManagingPatient andcase base data	Yes	Yes
Collection ofstudymaterial	Yes	Yes
Alignment ofstudymaterial	Yes	Yes
Measuringstudymaterial	Yes	Yes
AnalyzingStudyMaterial	Yes	Yes	Same
TreatmentSimulation	Yes	Yes
VirtualApplianceDesign	Yes	Yes
Surface scanforintraoralscanner	Yes	Yes
Surface scanfrom STL file	Yes	Yes
Characteristic	ArchForm Orthodontic Software System	Orchestrate 3D Orthodontic Software	Comparison
Analysis andTreatment
Arch Shape	Yes	Yes
Overbite /Overjet	Yes	Yes
Occlusal Map	Yes	Yes
3D TreatmentSimulation	Yes	Yes
OrthodonticApplianceVirtualPreparation	Yes	Yes	Same
OrthodonticApplianceDesign	Yes	Yes
OrthodonticApplianceExport	Yes	Yes

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Submitter: ArchForm, Inc.

ArchForm Orthodontic Software System

Premarket Notification: Traditional 510(k)

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Submitter: ArchForm, Inc.

ArchForm Orthodontic Software System

Premarket Notification: Traditional 510(k)

Conclusion: Based on comparison of indications for use, technological features, performance testing, and software validation testing, the ArchForm Orthodontic Software System has 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.