eRAD PACS is a software-only medical device used to receive medical images, scheduling information and clinical reports, organize and store them in an internal format, and make the information available across a network via web and customized user interfaces.

eRAD PACS includes software intended for use by qualified professionals for the presentation, review and comparison of diagnostic medical images.

eRAD PACS is for hospitals, imaging centers, reading practices, radiologists, technicians, physicians and other users who require and are granted access to patient image, exam and report information.

The eRAD PACS viewer displays images from DICOM compliant modalities and other devices including CT, computed and digital radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light systems.

Lossy compressed images and digitized film images must not be used for primary diagnosis of mammography studies. When displaying mammography images for clinical interpretation, only monitors having regulatory clearance for mammography interpretation should be used.

Device Description

eRAD PACS is a software-only medical image management and processing system, comprised of a central systems manager component, diagnostic viewing components, and an archiving component.

The system is used for patients who undergo an imaging procedure deemed necessary by the patient's physician.

The data flow is as follows:

Patient and procedure information is optionally acquired by the central system manager to prepare for the acquisition of image objects.
-Image objects are acquired from the image sources, such as imaging modalities, PACS, data archives, and other devices.
After receiving the procedure information or the image objects, the central system manager searches for and retrieves relevant prior procedure data from the archiving component.
When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information from a workstation by selecting the item from the operator's worklist.
The image data is transmitted to and rendered on the user's workstation using the diagnostic viewing components.
-After reviewing the images in the diagnostic viewer, the user optionally creates a clinical report using a text editor or a commercially available speech recognition solution.
-Once the central system manager registers a report, the report is available for access by the referring physician, or it can be exported into a third-party information system.
At some configured point in time, the image data and the report information are delivered to the archiving component for backup and long-term storage.

AI/ML Overview

The provided document, a 510(k) premarket notification for eRAD PACS, does not contain explicit acceptance criteria or a detailed study proving the device meets these criteria in the way a clinical performance study for an AI/ML medical device would.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (eRAD PACS, K120995). The crucial statement regarding testing is:

"Thorough non-clinical system verification and validation testing was conducted in accordance with applicable standards and internal design procedures to verify that the eRAD PACS software product meets user needs and its intended use. Testing demonstrated that the eRAD PACS software product is substantially equivalent to the predicate device."

This indicates that the "study" conducted was primarily non-clinical verification and validation (V&V) testing for a software-only medical image management and processing system (PACS), not a clinical performance study involving human readers or standalone algorithm performance against a clinical ground truth.

Therefore, for the specific questions asked, a direct answer cannot be fully provided from the given text as the nature of the submission (510(k) for a PACS update) does not require the same type of clinical performance data as, for example, an AI algorithm for disease detection.

However, I can deduce and infer information based on the context of a PACS 510(k) submission:

Analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, AUC) for the eRAD PACS. Instead, the acceptance criterion for this 510(k) submission is implicitly "substantial equivalence" to the predicate device for its intended use, as verified by non-clinical V&V testing. This means the device must function as intended, handle images correctly, and meet the relevant technical specifications and standards (e.g., DICOM compliance).
Reported Device Performance: The document states: "Testing demonstrated that the eRAD PACS software product is substantially equivalent to the predicate device." This is the reported performance. Specific numerical metrics are not provided because the "performance" here refers to the system's ability to manage and display images functionally as a PACS, not to diagnostic accuracy.

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

The document mentions "non-clinical system verification and validation testing." For a PACS system, this typically involves testing with a diverse set of synthetic and real-world DICOM images to ensure proper handling, display, and archiving across various modalities.
Sample Size: Not specified. It would likely involve a large variety of DICOM images and system configurations to test different functionalities and edge cases.
Data Provenance: Not specified. Given it's V&V for a PACS, the "data" would be medical images (DICOM files) from various modalities. It is likely a mix of internally generated test data, publicly available datasets, and potentially de-identified clinical data, but this is not stated. The provenance (country, retrospective/prospective) of these images is not detailed.

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

Not applicable in the context of this 510(k) submission. Ground truth established by experts is typically for validation of diagnostic accuracy (e.g., for an AI algorithm interpreting images), not for the functional performance of a PACS.
For PACS V&V, the "ground truth" is that the system correctly displays the image, stores it accurately, and performs its functions as specified. This is verified by engineers and testers against technical specifications, not by clinical experts establishing diagnostic "ground truth."

4. Adjudication Method for the Test Set:

Not applicable. Adjudication (e.g., 2+1, 3+1) is a method used in clinical studies to establish a rigorous "ground truth" for diagnostic tasks, usually when there is observer variability. This is not mentioned as part of the PACS V&V.

5. MRMC Comparative Effectiveness Study:

No evidence. The document does not describe an MRMC study comparing human readers with and without AI assistance. This type of study is relevant for AI algorithms intended to aid diagnosis, not for a PACS system whose primary function is image management and display.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

Not applicable. The eRAD PACS is described as a "medical image management and processing system" and a "viewer" for qualified professionals. It is not an AI algorithm performing a diagnostic task independently. Its "performance" is in its ability to correctly manage and display images.

7. Type of Ground Truth Used:

Technical Specifications and DICOM Standards: For a PACS system, the "ground truth" for verification and validation is primarily defined by its technical specifications (e.g., image fidelity, display characteristics, network communication standards like DICOM, storage integrity) and user requirements. It's about whether the system functions correctly as an imaging management system, not about establishing clinical diagnostic truth from patient outcomes or pathology.

8. Sample Size for the Training Set:

Not applicable. The eRAD PACS described is not an AI/ML device that requires a "training set" in the machine learning sense. It's a software system built based on established programming principles and standards.

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

Not applicable. As a non-AI/ML PACS, there is no "training set" or corresponding ground truth establishment process in the way an AI model would have.

Summary based on context:

The eRAD PACS 510(k) submission describes an update to an existing PACS system, specifically a "restructure of the internal components for deployment in a cloud environment." For such a device, the regulatory burden focuses on ensuring that the changes do not undermine the safety and effectiveness established by the predicate device. This is achieved through non-clinical verification and validation testing against technical specifications and performance requirements of an image management system. It is not a clinical study involving diagnostic accuracy metrics or human reader performance.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.

eRAD, Inc. Jaye Marotta Q & R Leader 201 Brookfield Parkway Suite 160 Greenville, South Carolina 29607

October 31, 2024

Re: K241223

Trade/Device Name: eRAD PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management mnd processing system Regulatory Class: Class II Product Code: LLZ Dated: September 17, 2024 Received: September 23, 2024

Dear Jave Marotta:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software 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

Submission Number (if known)

K241223

Device Name

eRAD PACS

Indications for Use (Describe)

eRAD PACS includes software intended for use by qualified professionals for the presentation, review and comparison of diagnostic medical images.

eRAD PACS is for hospitals, imaging centers, reading practices, radiologists, technicians, physicians and other users who require and are granted access to patient image, exam and report information.

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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Image /page/4/Picture/0 description: The image shows the logo for eRad. The logo features a stylized letter 'e' in red, followed by the text 'RAD' in gray. To the left of the 'e' are three curved lines in shades of gray, resembling a stylized orbit or a visual representation of radiation. The overall design is clean and modern, suggesting a company involved in technology or medical imaging.

K241223

510(k) Executive Summary

Submitter:	eRAD, Inc.201 Brookfield Parkway, Suite 160Greenville, SC 29607
Contact Person:	Jaye MarottaQuality Systems ManagereRAD, Inc.O: 973-277-4773F: 864-751-7560JMarotta@erad.com
Official Correspondent:	Nathan HuntHead of Quality, Regulatory, and ComplianceDeepHealth, Inc.O: 864-234-7430F: 864-751-7560Nathan.Hunt@DeepHealth.com
Date Prepared:	04.25.2024
Classification Name:	System, Image Processing, Radiological
Common Name:	MIMPS, PACS
Proprietary Name:	eRAD PACS
Predicate Devices:	eRAD PACS, #K120995 (December 3, 2012)

Device Description:

eRAD PACS is a software-only medical image management and processing system, comprised of a central systems manager component, diagnostic viewing components, and an archiving component.

The system is used for patients who undergo an imaging procedure deemed necessary by the patient's physician.

The data flow is as follows:

Patient and procedure information is optionally acquired by the central system manager to prepare for the acquisition of image objects.
-Image objects are acquired from the image sources, such as imaging modalities, PACS, data archives, and other devices.
After receiving the procedure information or the image objects, the central system manager searches for and retrieves relevant prior procedure data from the archiving component.

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Image /page/5/Picture/0 description: The image shows the logo for eRAD, a medical imaging software company. The logo features a stylized letter "e" in a dark red color, followed by the letters "RAD" in gray. To the left of the "e" are three curved lines in shades of gray, resembling a stylized "C" shape. The logo is simple, modern, and professional, reflecting the company's focus on technology and healthcare.

When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information from a workstation by selecting the item from the operator's worklist.
The image data is transmitted to and rendered on the user's workstation using the diagnostic viewing components.
-After reviewing the images in the diagnostic viewer, the user optionally creates a clinical report using a text editor or a commercially available speech recognition solution.
-Once the central system manager registers a report, the report is available for access by the referring physician, or it can be exported into a third-party information system.
At some configured point in time, the image data and the report information are delivered to the archiving component for backup and long-term storage.

Intended Use:

eRAD PACS includes software intended for use by qualified professionals for the presentation, review and comparison of diagnostic medical images.

eRAD PACS is for hospitals, imaging centers, reading practices, radiologists, technicians, physicians and other users who require and are granted access to patient image, exam and report information.

The eRAD PACS viewer displays images from DICOM compliant modalities and other devices including CT, computed and digital radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound. x-ray angiography, x-ray fluoroscopy and visible light systems.

Substantial Equivalence:

The modifications to the eRAD PACS software device do not alter the fundamental scientific technology of the device. The modification made to the predicate device is a restructure of the internal components for deployment in a cloud environment.

Discussion of Non-Clinical Testing Performed:

Thorough non-clinical system verification and validation testing was conducted in accordance with applicable standards and internal design procedures to verify that the eRAD PACS software product meets user needs and its intended use. Testing demonstrated that the eRAD PACS software product is substantially equivalent to the predicate device.

Conclusions:

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Image /page/6/Picture/0 description: The image shows the logo for eRAD, a medical imaging software company. The logo features a stylized letter "e" in red, followed by the word "RAD" in gray. To the left of the "e" are three curved lines in shades of gray, resembling sound waves or a stylized "C". The overall design is modern and professional, reflecting the company's focus on technology and healthcare.

The information provided in this premarket notification submission has shown that the eRAD PACS software product is substantially equivalent to the predicate device and is as safe and effective as the predicate for its intended use.

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).