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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.

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eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. eRAD PACS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.

eRAD PACS is a PACS system, comprised of acquisition components (GatewayServer and SendServer), a central system manager component (SmartServer), a diagnostic workstation component (Workstation and Viewer), (and an archiving component (ArchiveServer). The data flow is such that patient and on and 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 information of and retrieves relevant procedure data from the archive 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 by oreading and the user's workstation using the diagnostic workstation 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 dictation and transcribe it to text. Once eRAD PACS's central system manager registers a and 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.

eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in internal format, and to make that information available across a network via web and customized user interfaces.

This document describes the eRAD PACS (Picture Archiving and Communications System), a medical device intended for managing and displaying medical images and related information. However, the provided text does not contain information about specific acceptance criteria for device performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.

The document focuses on:

• Company Identification and Submission Details: Basic administrative information.
• Device Name and Substantial Equivalence: Classifies the device as a PACS soft-copy reading and acquisition system and asserts its substantial equivalence to other legally marketed PACS devices (Stentor's iSite, Toshiba's TICS, Ultravisual's Vortex, Dynamic Imaging's INTEGRADWeb MPR/MIP).
• Device Description and Intended Use: Explains the components and workflow of eRAD PACS (acquisition, central system manager, diagnostic workstation, archiving) and its purpose in hospitals, imaging centers, and radiology practices.
• Software Development: States that the software is designed, developed, tested, and validated according to written procedures.
• Safety and Effectiveness: Claims that the device has a "minor" level of concern and raises no new safety or effectiveness issues compared to predicate devices.
• FDA Communication: A letter from the FDA confirming the device's substantial equivalence and permitting its marketing.

Therefore, based solely on the provided text, I cannot provide the requested information regarding acceptance criteria or the study proving their fulfillment. The document does not describe:

1. A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., image quality, processing speed, diagnostic accuracy) or their targets are mentioned.
2. Sample size for the test set and data provenance: No test sets, patients, or images used for evaluation are described.
3. Number of experts and their qualifications for ground truth: No expert involvement in establishing ground truth is mentioned.
4. Adjudication method for the test set: No adjudication process is described.
5. MRMC comparative effectiveness study: No study involving human readers with or without AI assistance is mentioned.
6. Standalone performance study: No study evaluating the algorithm's performance independent of human readers is described.
7. Type of ground truth used: No mention of expert consensus, pathology, or outcomes data being used as ground truth.
8. Sample size for the training set: No training set or its size is mentioned.
9. How ground truth for the training set was established: Not applicable, as no training set is mentioned.

The document discusses "testing" and "validation" as part of software development, but it does not detail the nature of these tests, their specific objectives, the data used, or the performance metrics achieved. It primarily focuses on the device's functional equivalence to existing PACS systems and adherence to general safety and software development practices.

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