SmartCeph software is designed for use by dental practices for cephalometric tracing and presenting patient images which are utilized by dental professionals to assist in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners.

Device Description

SmartCeph is a software-only dental image device which allows the user to digitize landmarks on a patient's digital lateral cephalometric x- ray image, trace cephalometric structures, view cephalometric measurements, and superimpose images for analysis and presentation.

SmartCeph is imaging software designed for use in dentistry. The main SmartCeph software functionality includes image visualization, cephalometric tracing and measurements.

SmartCeph is used by dental professional for the visualization of patient images retrieved from a dental cephalometric imaging device scanner for assisting in case diagnosis, review and treatment planning for orthodontic and orthognathic applications. If a suitable JPEG image (specifically, a lateral cephalometric x-ray) has been imported into the software, the software can be utilized to define a number of structures and landmarks to establish specific anatomical features. The positions of specific landmarks are used to render tracing lines and calculate measurements used in orthodontic treatment planning. If multiple x-ray images for which cephalometric data has been digitized are imported, the resulting tracings can be overlaid to indicate changes and/or differences in the anatomy. The software operates upon standard Windows PC hardware and displays images on the PC's connected display/monitor.

SmartCeph is a standalone product but is designed to work cooperatively with Ortho2's dental practice management software that is used for scheduling and billing.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria and a study proving that the device meets these criteria. The document is a 510(k) summary for the SmartCeph device, primarily focusing on its substantial equivalence to a predicate device (Dolphin Imaging).

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated or in a table format. The document generally implies that the device should perform in a manner "substantially equivalent" to the predicate device, particularly for cephalometric tracing and measurement.
Reported Device Performance: The document states that "Ortho2, LLC has conducted extensive non-clinical (bench) performance testing and validation and verification testing of SmartCeph. All the different components of the SmartCeph have been stress tested to ensure that SmartCeph provides all the capabilities necessary to operate in a manner substantially equivalent to the Dolphin Imaging predicate." However, specific performance metrics (e.g., accuracy, precision, error rates) or a comparison against predefined criteria are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "non-clinical (bench) performance testing" but does not detail the dataset used for this testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document mentions that "Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners," indicating human oversight, but doesn't specify how ground truth was established for testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. 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

A MRMC comparative effectiveness study is not mentioned. The purpose of the substantial equivalence claim is often to avoid such extensive clinical studies if the device is similar enough to a legally marketed predicate. The device description emphasizes cephalometric tracing and measurement, which might lend itself more to objective performance metrics rather than reader improvement with AI assistance, especially since the document specifies that the "Diagnosis is not performed by this software but by doctors and other qualified individuals."

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

The document implies a standalone evaluation in the "non-clinical (bench) performance testing" and states that "SmartCeph is a standalone product." However, the performance metrics of this standalone evaluation are not detailed. It's described as "software-only" and performs digitizing landmarks, tracing, viewing measurements, and superimposing images.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided. Given the nature of cephalometric tracing, ground truth would typically involve expert manual annotations, but this is not confirmed in the text.

8. The sample size for the training set

This information is not provided. The document makes no mention of a training set or machine learning aspects, though a device performing "automatic structure drawing" (as mentioned in the comparison table) typically involves a training phase.

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

This information is not provided.

In summary, the document states that "extensive non-clinical (bench) performance testing and validation and verification testing" was conducted to ensure substantial equivalence. However, it does not provide the specific details about the acceptance criteria, study design (sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods) or reported performance metrics.

Summary

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October 17, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ortho2, LLC % W. Edward Johansen Official Correspondent 1239 Stanford Street, #205 SANTA MONICA CA 90404

Re: K190162

Trade/Device Name: SmartCeph Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 10, 2019 Received: September 12, 2019

Dear Mr. Johansen:

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/cfpmp/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 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

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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 medical devices and radiation-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

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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VI. Indications for Use

510(k) Number (if known)

K190162

Device Name SmartCeph

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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VII. 510(k) Summary

510k Number: K190162

A. Applicant Information

Date Prepared: October 9, 2019

Corporate Name: Ortho2, LLC

Address: 1107 Buckeye Avenue, Ames, lowa 50010

Device Trade Name: SmartCeph

Manufacturer: Ortho2, LLC

Classification Name: Picture Archiving and Communications System

Product Code: LLZ

Classification: Class II

Panel: Radiology

Regulation Number: 21 C.F.R. 892.2050

Submitter: Amy Schmidt, President

Telephone Number: (515) 233-1026

Contact Person: W. Edward Johansen, Official Correspondent

Telephone Number: (310) 795-7425

B. Predicate Device

SmartCeph is substantially equivalent to the following FDA cleared Dolphin Imaging predicate with regards to indications for use, intended use, performance and technological characteristics:

Proprietary Name: Dolphin Imaging

Corporate Name: Patterson Dental Supply, Inc. doing business as Dolphin Imaging & Management

510(k) Number: K110430

Classification Name: Picture Archiving and Communications System

Product Code: LLZ

Classification: Class II

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Panel: Radiology

Regulation Number: 21 C.F.R. 892.2050

C. Device Description

SmartCeph is imaging software designed for use in dentistry. The main SmartCeph software functionality includes image visualization, cephalometric tracing and measurements.

SmartCeph is a standalone product but is designed to work cooperatively with Ortho2's dental practice management software that is used for scheduling and billing.

D. Intended Use/Indications for Use

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E. Technical Characteristics

SmartCeph is a software only device that handles digital medical images. SmartCeph neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.

SmartCeph allows the user to digitize landmarks on a patient's digital lateral cephalometric x-ray image, trace cephalometric structures, view cephalometric measurements, and superimpose images for analysis and presentation.

SmartCeph is a Windows Executable written in C# language, that is intended for use on modern Windows PCs. SmartCeph operates on most computer workstations capable of running the Microsoft Windows 7 Professional operating system, and above, with a minimum of 2GB RAM, 128MB Video RAM, DirectX 9 Tier1, resolution of 1600 x 900, and a Windows Experience Index of 4 or better. SmartCeph also requires Microsoft .NET Framework 3.5 SP1 or greater.

F. Recognized Standards

SmartCeph is software that conforms to the following recognized standards.

ISO 14971 Medical Devices-Application of Risk Management to Medical Devices

IEC 62304 Medical Device Software Life Cycle Processes

G. Comparing the Dolphin Imaging Predicate to SmartCeph

Below the Comparison Table compares the Dolphin Imaging predicate to SmartCeph.

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Comparison Table

501(k) Number	K110430	K190162
Trade/Device Name	Dolphin Imaging	SmartCeph
Intended Use	Dolphin Imaging issoftware that isdesigned for use byspecialized dentalpractices for capturing,storing and presentingpatient images andassisting in treatmentplanning and casediagnosis. Resultsproduced by thesoftware's diagnosticand treatment planningtools are dependent onthe interpretation oftrained and licenseddental practitioners.	SmartCeph software isdesigned for use bydental practices forcephalometric tracingand presenting patientimages which areutilized by dentalprofessionals to assist intreatment planning andcase diagnosis. Resultsproduced by thesoftware's diagnosticand treatment planningtools are dependent onthe interpretation oftrained and licenseddental practitioners.
Operation System	Windows or Mac OS	Windows
User Interface	Mouse, Keyboard	Mouse, Keyboard
Indication for Use	Dolphin Imagingsoftware is designedfor use by specializeddental practices forcapturing, storing andpresenting patientimages and assistingin treatment planningand case diagnosis.Results produced bythe software'sdiagnostic andtreatment planningtools are dependent onthe interpretation of	SmartCeph software isdesigned for use bydental practices forcephalometric tracingand presenting patientimages which areutilized by dentalprofessionals to assistin treatment planningand case diagnosis.Results produced by thesoftware's diagnosticand treatment planningtools are dependent onthe interpretation of
	trained and licensedpractitioners.	trained and licensedpractitioners.
Technology Platform	PC and MAC based	PC
Image rendering	2D and 3D	2D
Image manipulation	Preview, Rotate,Enhance, Zoom,Brightness, Contrast,Sharpness	Preview, Rotate,Enhance, Zoom,Brightness, Contrast,Sharpness
Basic Imagemeasurement	Distance, angle	Distance, angle
Standalone software	Yes	Yes
Cephalometricmeasurement	Distance, angle, ratio,difference	Distance, angle, ratio,difference
Cephalometrictracing	Manual point pickingand automaticstructure templatesSoftware providespredefined landmarksand tracing structures.Can trace on 3Dvolume and 2D photo.	Manual point picking,auto and manualstructure drawing.Software providespredefined landmarks,structures and allowsuser to define theirown.
Cephalometricanalysis	Provide both 3D and2D analysis. 3Danalysis is performedon 3D volume. 2Danalysis is performedon 2D photo or x-ray.Standard orthodontictracing analyses anduser-configurableanalysis:Lateral Analyses:- Ricketts- McNamara- Steiner (Tweed)- Jarabak- Roth	Provides 2D analysison photo or lateral x-ray. User-configurableand standardorthodontic tracinganalyses including:ABO AnalysisAlabamaDownsMcLaughlinMcNamaraRickettsSteinerTweedWITS

	SassouniMcLaughlinDowns-NorthwesternBjorkAlexander (Vari-Simplex)HoldawayAlabamaBurstone
Tracingsuperimposition	Yes	Yes
Wiggle gram	Yes. Allow user toenter norms andstandard deviations.	Yes
2D growth simulation	Yes. Growth forecaston traced x-ray ortracing overlaid onphoto	No
Treatment planningand simulation	Orthodontic andorthognaticapplications usingmaxillary, mandible,and chin cuts	Orthodontic andorthognaticapplications usingpredefined andcustom analysis. No

	User can translate, rotate the cuts.	simulation.
Soft tissuedeformation	Yes. 2D and 3D	No
Photo wrapping	Can wrap 2D and 3Dphotos on volumeimage	No
Implant module	Yes (IMPLANNER)	No
Scanner connection	Yes	No
DICOM support	Yes	No
Regulation Number	21 CFR 892.2050	21 CFR 892.2050
Regulation Name:system	Picture archiving andcommunicationssystem	Picture archiving andcommunicationssystem
Regulatory Class	Class II	Class II
Product Code	LLZ	LLZ
Manufacturer	Patterson DentalSupply, Inc. doingbusiness as DolphinImaging & Management	Ortho2, LLC

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H. Substantial Equivalence Rationale

Although there are some differences between SmartCeph and the Dolphin Imaging predicate, comparing the non-clinical (bench) performance testing of SmartCeph for its device description, its technical characteristics, its intended use and its indications of use to similar aspects of the Dolphin Imaging predicate demonstrates that SmartCeph is substantially equivalent to the Dolphin Imaging predicate.

There are some differences between SmartCeph and the Dolphin Imaging predicate in that SmartCeph does not acquire images, but rather receives images.

SmartCeph does not contain the functionalities contained in the Dolphin lmaging major components (modules) of: ImagingPlusTM , Treatment Simulation, Arnett/Gunson FAB, McLauglin Dental VTO, ImplannerTM, Dolphin 3D, or the Dolphin Letter System.

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SmartCeph does not provide simulations of orthodontic or surgical treatment results.

SmartCeph does not perform face, airway, bite, or tooth position analyses and it does not provide for simulated dental implants.

SmartCeph does not accept or process 3D volumetric data in any way, and it does not contain a letter generating system.

The lack of these features does not impact cephalometric tracing, viewing cephalometric measurements, receiving images and superimposing images for analysis and presentation.

None of the above-mentioned differences changes any of the Safety or Effectiveness or Indications for Use of SmartCeph as compared to the Ceph Tracing module of the Dolphin Imaqing predicate.

The comparison table compares SmartCeph to the Dolphin Imaging predicate with respect to intended use, indications of use, environment of use, limitations of use, technical performance and technological characteristics. The comparison chart provides additional information regarding the basis for the determination of substantial equivalence.

I. Summary of Non-Clinical (bench) Performance Testing

Ortho2, LLC has conducted extensive non-clinical (bench) performance testing and validation and verification testing of SmartCeph. All the different components of the SmartCeph have been stress tested to ensure that SmartCeph provides all the capabilities necessary to operate in a manner substantially equivalent to the Dolphin Imaging predicate.

J. Conclusion

Based on the comparison of intended use, indications for use and technological characteristics SmartCeph is substantially equivalent to the Dolphin Imaging predicate. Ortho2, LLC has conducted extensive non-clinical (bench) performance, validation and verification testing indicating that SmartCeph provides reliable post- processing information to ensure that SmartCeph provides all the capabilities necessary to operate in a manner substantially equivalent to the Dolphin Imaging predicate.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).