(245 days)
eRAD PACS/ eRAD RIS/PACS is a PACS software product used to receive DICOM images, scheduling information and textual report, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces.
The eRAD PACS/ eRAD RIS/PACS viewer software is intended for use as a primary diagnostic and analysis tool for diagnostic images. eRAD PACS/ eRAD RIS/PACS is for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
The eRAD PACS/ eRAD RIS/PACS viewer displays images from CT, computed radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light modalities.
Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA.
eRAD PACS/ eRAD RIS/PACS Software Product is a PACS system, comprised of acquisition components, a central systems manager component, diagnostic viewing components, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. After receiving the procedure information or after receiving image objects, the central system manager searches for and retrieves relevant prior procedure data from the archiving a component. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the item from the operator worklist. The image data is transmitted to and rendered on the user's workstation using the diagnostic viewing components. After using the workstation to view the images, the user optionally dictates a report into the system, after which, a user can play back the diction and transcribe it to text. Once eRAD PACS's central system manager registers a report, the report is available for access by the referring physician, or it can be exported into an information system. At some configured point in time, the image data and the report information is delivered to the archiving component for backup and long-term storage.
The provided 510(k) submission for K120995 (eRAD PACS/eRAD RIS/PACS Software) does not contain acceptance criteria or a detailed study proving the device meets specific performance criteria in the way a clinical performance study for an AI/CADe device would.
This submission is for a Picture Archiving and Communications System (PACS), which is a foundational medical imaging infrastructure. The "testing" referred to is about demonstrating that the modified software (making it available in a software-only option) is substantially equivalent to its predicate devices and functions as intended, not about its diagnostic performance against specific clinical endpoints.
Therefore, many of the requested elements for a clinical performance study are not applicable to this documentation.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of a clinical performance study. The 510(k) focuses on substantial equivalence for a PACS system, not on specific diagnostic performance metrics like sensitivity or specificity. The "performance" assessment is about system functionality and equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical "test set" in the context of diagnostic performance (e.g., a set of patient images with confirmed diagnoses) is described. The non-clinical testing mentioned refers to system verification and validation against design requirements.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, as it pertains to diagnostic accuracy, is not established or discussed in this submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or ground truth adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC study was not done, as this submission is not about the diagnostic performance of an AI/CADe tool requiring human-in-the-loop assessment.
6. Standalone (Algorithm Only) Performance Study
No. A standalone performance study for an algorithm's diagnostic capabilities was not performed. The device is a PACS system, intended for displaying and managing images for human interpretation, not an automated diagnostic algorithm.
7. Type of Ground Truth Used
Not applicable. No ground truth for diagnostic purposes is mentioned. The testing focused on functional verification and validation of the PACS system.
8. Sample Size for the Training Set
Not applicable. The device is a PACS system, not an AI or machine learning algorithm that requires a training set in the diagnostic performance sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided documentation.
Summary of what the submission does say about "testing":
- Discussion of Non-Clinical Testing Performed: "Thorough non-clinical system verification and validation testing was conducted in accordance with applicable international standards and internal design requirement to verify that the eRAD PACS/ eRAD RIS/PACS Software Product meet user needs and indications for use. Testing demonstrated that the eRAD PACS/ eRAD RIS/PACS Software Product were substantial equivalent to their predicate devices." (Page 2)
- Conclusions: "The information provided in this premarket notification submission has shown that the eRAD PACS/ eRAD RIS/PACS Software Product is substantially equivalent to the predicate devices and are safe and effective for its intended use." (Page 3)
In essence, this 510(k) focuses on demonstrating that the eRAD PACS is functionally equivalent to its predicate, safe, and effective for its intended use as a PACS system, not on providing evidence of diagnostic accuracy comparable to an AI/CADe device.
§ 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).