Dolphin Imaging 12.0 software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting 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 practitioners.

Device Description

Dolphin Imaging 12.0 software provides imaging, diagnostics, and case presentation capabilities for dental specialty professionals. The Dolphin Imaging 12.0 suite of software products is a collection of modules that together provide a comprehensive toolset for the dental specialty practitioner. Users can easily manage 2D/3D images and x-rays; accurately diagnose and treatment plan, quickly communicate and present cases to patients and can work efficiently with colleagues on multidisciplinary cases. The below functionalities make up the medical device modules:
Cephalometric Tracing: Digitize landmarks on a patient's radiograph, trace cephalometric structures, view cephalometric measurements, superimpose images for analysis and perform custom analysis.
Treatment Simulation (VTO): Simulate orthodontic and surgical treatment results using Visual Treatment Objective (VTO) and growth features.
Arnett/Gunson FAB Analyses: Perform face, airway, bite (FAB) analysis and simulate treatment for orthodontic and surgical cases based on the methodologies of Dr. William Arnett.
McLaughlin Dental VTO: Analyze and evaluate orthodontic and surgical visual treatment objective (VTO) based on the theories of Dr. Richard McLaughlin.
Implanner™: Plan dental implant procedures in 2D.
Dolphin 3D: Plan, diagnose and present orthodontic and surgical cases, airway analysis, study models, implant planning and surgery treatment simulation in 3D.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for "Dolphin Imaging 12.0." This document primarily focuses on establishing substantial equivalence to a predicate device (Dolphin Imaging 11.5) rather than presenting a detailed acceptance criteria and study proving device performance against such criteria for a novel AI/ML medical device.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance metrics (like accuracy, sensitivity, specificity, MRMC studies, standalone performance, and ground truth establishment), is not present in the provided document.

The document states: "No clinical testing was required to support substantial equivalence." This indicates that no new performance studies (clinical or non-clinical, beyond basic software and system testing) were conducted or needed for this specific 510(k) clearance, as the changes were deemed moderate and the device maintained the same "key medical device functionality" as its predicate.

The "Non-Clinical Performance Testing" section lists general software and system testing (Performance Testing, Manual Testing/Integration Testing, System and Regression testing) and adherence to recognized standards (Usability, Software Life Cycle, DICOM, Risk Management). These are standard validation practices for software modifications, not performance studies as typically understood for AI/ML devices with specific numerical acceptance criteria.

To directly answer your request based on the provided text:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

No specific acceptance criteria related to a numerical performance metric (e.g., accuracy, sensitivity, AUC) for a diagnostic AI/ML algorithm are mentioned or detailed in this 510(k) summary.

No study proving the device meets specific performance-based acceptance criteria (as would be typical for an AI/ML algorithm) is described. The 510(k) submission primarily relies on demonstrating substantial equivalence to a previously cleared predicate device due to software usability enhancements and system updates, rather than a new AI-driven diagnostic capability.

However, if we were to infer the closest thing to "acceptance criteria" and "proof" from the document's context of substantial equivalence and safe and effective functionality, it would be:

Acceptance Criteria (Implied): The Dolphin Imaging 12.0 software operates with the same core medical device functionalities (listed in the "Medical Device Features" table) as the predicate (Dolphin Imaging 11.5) without introducing new safety or efficacy concerns. Usability enhancements are functional and do not degrade existing performance. Compliance with specified industry standards (IEC, DICOM, ISO) is met.
Study Proving Acceptance (Implied): The "Non-Clinical Performance Testing" which included "Performance Testing," "Manual Testing/Integration Testing," and "System and Regression testing," alongside adherence to recognized standards, served to demonstrate that the updated software continued to function as intended and comparably to the predicate, with the added usability enhancements.

Responding to your specific numbered points, recognizing that this document is not for a novel AI/ML algorithm performance study:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as numerical performance targets. Implicitly, the device must maintain the "Medical Device Features" as the predicate and perform comparably, without issues.
Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity) are reported. The "performance" is demonstrated through verification that the software functions as expected and complies with relevant standards.

Acceptance Criterion (Implied)	Reported Device Performance (as evident from clearance)
Maintains all "key medical device functionality" of predicate.	Confirmed via internal testing and substantial equivalence claim.
Usability enhancements function as intended.	Confirmed via internal testing.
No new safety or efficacy concerns compared to predicate.	Concluded by FDA based on submission.
Compliance with IEC 62366 (Usability Engineering).	Stated as compliant.
Compliance with ANSI/AAMI/IEC 62304 (Software Life Cycle).	Stated as compliant.
Compliance with NEMA PS 3.1-3.20 (DICOM).	Stated as compliant.
Compliance with ISO 14971 (Risk Management).	Stated as compliant.

Sample size used for the test set and the data provenance: Not applicable/not provided. This was a software upgrade submission, not an AI/ML diagnostic performance study requiring a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. No ground truth was established from clinical data for a diagnostic performance study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
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 MRMC study was performed or required. The device is described as "assisting in treatment planning and case diagnosis," with results "dependent on the interpretation of trained and licensed practitioners," implying a human-in-the-loop system, but no study on human performance improvement with the updated software is detailed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study was performed or required.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided for a diagnostic performance study. The "ground truth" for the software's functionality was its adherence to specifications and its comparable behavior to the predicate device.
The sample size for the training set: Not applicable/not provided. This is not an AI/ML model being trained on a dataset.
How the ground truth for the training set was established: Not applicable/not provided.

Summary

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August 8, 2022

Image /page/0/Picture/1 description: The image shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Patterson Dental Supply, Inc. % Ms. Erin Daly Sr. Regulatory Manager Dolphin Imaging & Management Solutions 9200 Oakdale Avenue, Ste 500 CHATSWORTH CA 91311

Re: K222072

Trade/Device Name: Dolphin Imaging 12.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 13, 2022 Received: July 14, 2022

Dear Ms. Daly:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (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 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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health 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)

K222072

Device Name Dolphin Imaging 12.0

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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510(K) SUMMARY

Dolphin Imaging 12.0 K22072

Administrative Information

Date Prepared:	13 July 2022
Submitter's Name and Address:	Patterson Companies1031 Mendota Heights RoadSaint Paul, MN 55120Contact: Erin DalyTelephone: (608) 345-4888
Trade or Proprietary Name:	Dolphin Imaging 12.0
Common or Usual Name:	Dental imaging software
Classification Name:	Medical image management and processing system
CFR Reference:	21 CFR 892.2050
Product Code:	LLZ
Regulatory Class:	Class II
Predicate Device:	K110430 - Dolphin Imaging
Reference Device(s):	Not applicable
Predicate Device Trade or ProprietaryName:	Dolphin Imaging 11.5K110430
Common or Usual Name:	Dental imaging software
Classification Name:	Medical image management and processing system
CFR Reference:	21 CFR 892.2050
Product Code:	LLZ

Product Description

Regulatory Class:

Class II

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Module	Overview
Cephalometric Tracing	Digitize landmarks on a patient's radiograph, trace cephalometricstructures, view cephalometric measurements, superimpose images foranalysis and perform custom analysis.
Treatment Simulation (VTO)	Simulate orthodontic and surgical treatment results using Visual TreatmentObjective (VTO) and growth features.
Arnett/Gunson FAB Analyses	Perform face, airway, bite (FAB) analysis and simulate treatment fororthodontic and surgical cases based on the methodologies of Dr. WilliamArnett.
McLaughlin Dental VTO	Analyze and evaluate orthodontic and surgical visual treatment objective(VTO) based on the theories of Dr. Richard McLaughlin.
Implanner™	Plan dental implant procedures in 2D.
Dolphin 3D	Plan, diagnose and present orthodontic and surgical cases, airway analysis,study models, implant planning and surgery treatment simulation in 3D.

Dolphin Imaging 12.0 is a software of Moderate level of concern. Dolphin Imaging maintains all the same key medical device functionality as the predicate Dolphin Imaging 11.5 (K110430). Usability enhancements to the Cephalometric Tracing and Analysis, Treatment Simulation (VTO), and Dolphin 3D modules are included in Dolphin Imaging 12.0, as well as system updates to allow use with current operating software and hardware capabilities

Indications for Use

Comparison to Predicate

Parameter	Subject Device	Predicate
	K222072 Dolphin Imaging 12.0	K110430 – 11.5 Dolphin Imaging
Intended Use	Dolphin Imaging 12.0 software isdesigned for use by specialized dentalpractices for capturing, storing andpresenting patient images and assistingin treatment planning and casediagnosis. Results produced by thesoftware's diagnostic and treatmentplanning tools are dependent on theinterpretation of trained and licensedpractitioners.	Dolphin Imaging software is designedfor use by specialized dental practicesfor capturing, storing and presentingpatient images and assisting intreatment planning and case diagnosis.Results produced by the software'sdiagnostic and treatment planning toolsare dependent on the interpretation oftrained and licensed practitioners.
Classification	Class II	Class II
Classification Code	LLZ	LLZ
Type of Use (Rx / OTC)	Rx	Rx
User	Orthodontic, oral maxillofacial surgery,and dental-specialty practices.	Orthodontic, oral maxillofacial surgery,and dental-specialty practices.
User Interface/OS	Local PC workstation with 64-bitMicrosoft Windows OS	Local PC workstation with MicrosoftWindows OS
Medical Device Features

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2D Image Digitize andMeasurements	Yes	Yes
2D Image Superimposition	Yes	Yes
2D Growth Forecast	Yes	Yes
2D Treatment Simulation	Yes	Yes
2D Custom Analysis Editor	Yes	Yes
3D Image Digitize andMeasurements	Yes	Yes
3D Airway Analysis	Yes	Yes
3D Image (Volume)Superimposition	Yes	Yes
3D Implant Simulation	Yes	Yes
2D/3D Orthognathic SurgicalPlanning	Yes	Yes

Non-Clinical Performance Testing

Dolphin Imaging 12.0 complies with applicable FDA recognized standards:

Usability (IEC)	Medical devices- Part 1: Application of usability engineering to
IEC 62366	medical devices
Software (IEC)ANSI/AAMI/IEC 62304: 2006 & A1:2016	Medical device software- Software life cycle process
DICOM (NEMA)NEMA PS 3.1-3.20 (2016)	Digital Imaging and Communications in Medicine (DICOM)
Risk Management	Medical devices- Application of risk management to medical
ISO 14971:2019	devices

Dolphin Imaging 12.0 design and performance verification involved the following tests:

Performance Testing ●
Manual Testing/ Integration Testing ●
. System and Regression testing

Clinical Performance Testing

No clinical testing was required to support substantial equivalence.

Conclusions

Dolphin Imaging 12.0 is substantially equivalent to the predicate device, Dolphin Imaging, and differences do not raise any concerns about safety or efficacy of the device.

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).