Dolphin Blue Imaging 2.0 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 Blue Imaging 2.0 is a software that provides imaging, diagnostics, and case presentation capabilities for dental specialty professionals. The Dolphin Blue Imaging 2.0 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 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:

Tracing Module
Measurements Module
Superimpositions Module

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets particular performance metrics. It focuses on regulatory aspects of the Dolphin Blue Imaging 2.0 software, asserting its substantial equivalence to predicate devices and outlining the general verification and validation processes followed.

However, based on the general information provided regarding verification and validation activities, we can infer some general acceptance an "Implied Acceptance Criteria" and what the document generally states regarding testing.

Implied Acceptance Criteria and Reported Device Performance

Since no specific quantitative performance metrics are provided as acceptance criteria, the table below reflects what can be inferred from the document's statements about successful verification and validation.

Acceptance Criteria (Inferred from documentation)	Reported Device Performance
Functions work as designed	Successfully verified
Performance requirements met	Successfully verified
Specifications met	Successfully verified
Hazard mitigations fully implemented	Successfully verified
Predetermined acceptance values met (for all testing)	Successfully met
System stability under specified workload	Verified through performance testing
Proper functioning of features (as end-user)	Verified through manual testing
Correct interconnections between applications/systems	Verified through integration testing
Compliance with ISO 14971 (Risk Management)	Adhered
Compliance with ISO 13485 (Quality Systems)	Adhered
Compliance with IEC 62304 (Medical Device Software Lifecycle)	Adhered
Compliance with DICOM (Digital Imaging and Communications in Medicine)	Designed in conformance with
Cybersecurity controls prevent unauthorized access, modifications, misuse, denial of use	Specific controls implemented
Cybersecurity controls prevent unauthorized use of stored, accessed, or transferred information	Controls enabled
Dolphin Blue Imaging 2.0 features mirror Dolphin Imaging features	Features were modeled after Dolphin Imaging features

Study Information

Sample Size used for the test set and the data provenance: Not explicitly stated within the provided text. The document refers to "Data sets are utilized while testing several categories" in the performance testing section but does not specify the size or provenance of these datasets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated within the provided text. The document mentions that "Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners," implying human interpretation is critical, but does not detail how ground truth was established for testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated within the provided text.
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: Not explicitly stated or indicated. The document focuses on the software's substantial equivalence and internal testing, not on human reader performance with or without AI assistance. The device is described as "assisting in treatment planning and case diagnosis," but no human-in-the-loop performance study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes various software tests (Unit, Performance, Manual, Integration, System, Regression testing) that would evaluate the algorithm's standalone performance in terms of functionality and adherence to specifications. However, it does not present a formal "standalone performance study" with specific metrics like sensitivity, specificity, or AUC against a ground truth. The focus is on verifying that the software "works as designed" and meets "performance requirements."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. The document mentions that cephalometric measurements are "calculated in real-time by the Dolphin Blue Ceph server" and that "Calculations take into consideration the race, gender, age, and customizable normal measurement values for a patient to indicate deviations from the accepted normal measurements." This suggests that the "ground truth" for calculations is based on established anatomical landmark locations and predefined normal measurement values, but the source or method of establishing these for the test set is not detailed.
The sample size for the training set: Not applicable and not stated. The document describes the software functionalities for image management, diagnostic tools (cephalometric tracing, measurements, superimpositions), and case presentation. It does not describe a machine learning or AI model that would require a distinct training set for itself, separate from the software's development and verification processes.
How the ground truth for the training set was established: Not applicable and not stated, as there is no mention of a distinct training set for an AI/ML model.

Summary

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November 1, 2022

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

Re: K221478

Trade/Device Name: Dolphin Blue Imaging 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: September 26, 2022 Received: September 27, 2022

Dear Erin 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,

For

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of 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) K221478

Device Name Dolphin Blue Imaging 2.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Beneficial Use (Per 31 CFR 801.2, subpart B)
On-Site Control Use (31 CFR 801.2, subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Patterson Companies logo. The logo consists of two curved shapes above the word "PATTERSON" in a sans-serif font. The curved shapes are arranged one above the other, with the top one slightly smaller than the bottom one. The word "PATTERSON" is in all caps and is followed by the registered trademark symbol.

1031 Mendota Heights Road Saint Paul, MN 55120 800.328.5536

510(K) SUMMARY

Dolphin Blue Imaging 2.0 K221478

Applicant Information:

Patterson Companies 1031 Mendota Heights Road, Saint Paul, MN 55120 Telephone: (608) 345-4888 Contact: Erin Daly Date Prepared: September 9, 2022

Trade Name/ Classification: Proprietary Name: Dolphin Blue Imaging 2.0 Classification Name/ Class: Medical image management and processing system Common Name: Medical image management and processing system Regulation Number: 21 CFR 892.2050 Product Code: LLZ Classification Panel: Radiology Devices

Predicate Device:

Dolphin Blue Imaging 2.0 is substantially equivalent to the following FDA approved predicate devices with regard to indications for use, performance, and technological characteristics.

510K Number: K110430 Trade Name: Dolphin Imaging Manufacturer: Patterson Dental Supply, Inc. Classification: II Regulation Number: 892.2050 Product Code: LLZ Classification Panel: Radiology Device

Reference Device:

510K Number: K132342 Trade Name: XVWeb Manufacturer: Apteryx, Inc. Classification: II Regulation Number: 892.2050 Product Code: LLZ Classification Panel: Radiology Device

Device Name	Dolphin Blue Imaging2.0(Proposed device)	Dolphin Imaging(Primary Predicate)	Apteryx(Reference Predicate)
510(k)	K221478	K110430	K132342
Classification	Device Class: IIClassification Code:LLZ	Device Class: IIClassification Code:LLZ	Device Class: IIClassification Code: LLZ
Intended Use	Dolphin Blue Imaging2.0 software is designedfor use by specializeddental practices forcapturing, storing and	Dolphin Imagingsoftware is designedfor use by specializeddental practices forcapturing,	XVWeb is a Picture Archivingand Communications System(PACS) that enables dentalfacilities to query and accessdigitally stored hard and soft

	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.	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.	tissue intraoral /extraoral radiological images using an internet/web browser. A web-based interface provides users the needed functionality to display patient images and studies in commercially available web browsers. Patient images/studies can be accessed by users locally within the system or across a wide-area network at distributed locations. Acquisition can be included via integration with a DICOM-compatible imaging application or server configured to forward images to the XV Web database. The system allows users to: manipulate (e.g. rotate, flip, etc.): enhance (e.g. increase or decrease brightness/contrast, gamma correction); add labels (e.g. measurements, lines, arrows, etc.), annotations to patient images/studies and other relevant operations for diagnostic purposes. XVWeb is designed for medium-to-large dental practices and is intended for trained dental professionals and technicians to access, manipulate, and enhance dental images for diagnostic purposes only.
Features
Imagemanipulation	Yes	Yes	Yes
Image printing	Yes	Yes	Yes
Cephalometrictracing andanalysis	Yes	Yes	N/A
Tracing/Imagesuperimposition	Yes	Yes	N/A
General
Windowscompatible	Yes	Yes	Yes
TWAINcompatible	Yes	Yes	Yes
Predefined andcustom analysistools	Yes	Yes	N/A
Digital imagingsoftwareintegrationcapability	Yes	Yes	Yes
Practicemanagementsoftwareintegrationcapability	Yes	Yes	Yes
TechnicalCharacteristics
Web-basedapplication	Yes	No	Yes
Interface Securedata transmission(HTTPS)	Yes	No	Yes
DatabaseManagement andStorage Secureserver andInfrastructure	Yes	Yes	Yes
Cloud Services	Yes	Yes	Yes

Table 1- Substantial Equivalence Summary

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Image /page/4/Picture/0 description: The image shows a blue logo with two curved shapes that mirror each other. The shapes are positioned horizontally, with one above the other, creating a symmetrical design. The logo appears to be simple and modern, with a focus on the curved lines.

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Image /page/5/Picture/0 description: The image shows a blue logo. The logo is composed of two curved shapes that are mirror images of each other. The shapes are arranged in a way that they almost form a circle, but with a gap in the middle. The logo is simple and modern, and the blue color gives it a sense of calmness and stability.

Description of Device:

Tracing Module

If a patient record contains a suitable image, cephalometric digitizing can be utilized to establish the locations of specific anatomical features. The inter-relational positions of these landmarks are used to render tracing lines and calculate cephalometric measurements, which are used in diagnosing patients and planning orthodontic and/or surgical procedures. An extensive library of existing cephalometric analyses is included with the software. The Blue Imaging server is used to manipulate the cephalometric landmark data. Storage in the patient's data record is done by utilizing Dolphin Data Storage.

Measurements Module

For images containing cephalometric tracing data, the user can view a list of measurements calculated according to the specific cephalometric analysis selected to view. Since digitized images contain only the locations of specific points (landmarks) on the patient anatomy, measurements lists are calculated in real-time by the Dolphin Blue Ceph server. Calculations take into consideration the race, gender, age, and customizable normal measurement values for a patient to indicate deviations from the accepted normal measurements.

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Image /page/6/Picture/0 description: The image shows a logo with two curved shapes facing each other. The shapes are blue and appear to be symmetrical. The logo is simple and modern, with a focus on the curved shapes.

Superimpositions Module

If a patient record contains multiple x-ray images for which cephalometric data has been digitized, the resulting tracings can be overlaid to indicate changes and/or differences in the anatomy. These overlays (superimpositions) are displayed and manipulated within the Dolphin Blue Ceph user interface. The Dolphin Blue Ceph server is responsible for calculating and rendering superimpositions in real-time.

The computer hardware used to access the web application must meet the following requirements:

. Operating System: Windows 10 or newer, Mac OS X (10.1 Yosemite) or newer
Intel Core i5 Processor .
8 GB RAM .
500 GB Hard Drive .
Gigabit Ethernet Adapter .
Screen Resolution 1366x768 .
Intel USB Chipset with USB 2.0 Ports (the number of ports needed will be based on what hardware will be used . on the workstation)
. Web Browser:
- Google Chrome (Latest version & latest 1) o
- O *Recommended
- Microsoft Edge (Latest version & latest 1) o
- Mozilla Firefox (Latest version & latest 1) O

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Image /page/7/Picture/0 description: The image shows a blue logo that consists of two curved shapes. The shapes are mirror images of each other and are positioned so that they appear to be facing each other. The logo is simple and modern in design. The blue color is bright and eye-catching.

Indications For Use:

Performance Data/Safety and Effectiveness:

Software Documentation for a Moderate Level of Concern software Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is included as part of this submission.

Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values. Traceability of the requirements specified in the requirement specifications and functions is ensured during component integration, software validation and system testing.

Risk Management has been ensured via risk analyses in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Patterson Companies adheres to recognized and established industry standards for development including EN ISO 13485 and IEC 62304.

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

Cybersecurity information in accordance with FDA Guidance documents issued October 2, 2014, has been provided. The software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse, or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed, or transferred between the software and external devices.

The device is designed and manufactured in accordance with Quality System Regulations as outlined in 21 CFR 820.30.

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

Dolphin Blue Imaging 2.0 is designed in conformance with the following FDA recognized standards:

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Image /page/8/Picture/0 description: The image shows a logo with two curved shapes that are mirror images of each other. The shapes are blue and appear to be flowing or swirling around a central point. The logo is simple and modern, and the blue color gives it a sense of calmness and stability. The logo is likely used by a company or organization that wants to convey a message of innovation, collaboration, or balance. The logo is visually appealing and easy to remember.

All Specifications of Dolphin Blue Imaging 2.0 are verified by several tests before release. Non-clinical testing, including verification tests, evaluated:

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

Unit Testing

Engineers perform unit testing before checking in code changes, to validate for the intended functionality. Code changes are validated for compilation upon check-in via an automated build process.

Performance Testing

Performance testing verifies the system stability and response under a specified workload and is conducted for each release. Data sets are utilized while testing several categories and evaluating if the page counts verify the system stability.

Manual Testing

Manual testing verifies the functions and features of the Dolphin Blue Imaging 2.0 product as an end-user would use the application to verify the software is working as designed and required. Manual tests are pre-defined

Integration Testing

Integration testing verifies the interconnections between applications and systems function correctly and evaluates whether systems or components pass data and control correctly to one another.

System and Regression Testing

System and regression testing are executed as part of the final testing on a release of a product. The plan includes the following as applicable:

a) System Tests executed as regression tests
b) Integration Tests executed as regression tests
c) other tests, such as exploratory testing executed as regression tests

Substantial Equivalence Conclusion:

Dolphin Blue Imaging 2.0 software was designed, tested, and validated according to written procedures. These procedures specify individuals within the organization responsible for developing product specifications, coding, testing, validating, and maintenance. Dolphin Blue Imaging 2.0 has successfully completed integration testing/verification testing and beta validation. In addition, potential hazards have been evaluated and controlled to an acceptable level.

Dolphin Blue Imaging 2.0 has similar function of Cephalometric tracing and tracing/image superimposition like its predicate device. Dolphin Imaging is a desktop-based software and Dolphin Blue Imaging 2.0 a web-based software, the difference does not raise any new questions regarding safety or effectiveness of the device. Dolphin Blue Imaging 2.0 features were modeled after Dolphin Imaging features. Thus, Dolphin Blue Imaging 2.0 is substantially equivalent to the predicate devices.

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).