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DR Systems Z3D is intended to provide reading physicians, and other appropriate healthcare professionals tools to aid in interpreting medical images, including:

· Displaying DICOM compliant medical image volumes, such as CT, MRI, and PET.

· Reformatting images, including creation of MPRs, MinIPs, color/monochrome 3D volume rendered images

· Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path.

· Creating series of DICOM images and individually captured images that can be displayed and stored in a PACS.

• Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.

DR Systems Z3D (Zero Download 3D) advanced imaging solution supports MIP (maximum intensity project), MPR (multiplanar reconstruction), 3D volume rendering, and cardiac calcium scoring. The system employs server-based rendering and browser-based viewing. Reading physicians, referring physicians, and other appropriate healthcare personnel and can employ advanced image processing and display from local or remote locations.

Viewing Modes:
Multiplanar reconstruction Two 3-D viewing modes, one showing 4 images, and one showing 6 images Cardiac calcium scoring

DR Systems Z3D is similar to the predicate device, Voxar 3D. Both are PACS system accessories that allow the user to view and manipulate 3D image data sets. DR Systems Z3D does not have an AvelP analysis tool. The principles of operation and technological characteristics of the new and predicate device are the same.

The provided text does not contain information about acceptance criteria for device performance or a study that specifically proves the device meets those criteria, especially in the context of clinical accuracy or effectiveness. The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device through nonclinical testing.

Here's what can be extracted from the document regarding testing and device characteristics, but it lacks the specific details requested concerning acceptance criteria and clinical study results:

Information on Nonclinical Testing (Verification, Validation, Usability):

• Nonclinical Testing: "DR Systems Z3D was designed, developed and tested according to DR System's written procedures. Testing included verification, validation and evaluation of human factors and usability." (Page 5)
• Quality Assurance Measures applied:
  • Risk analysis
  • Requirements reviews
  • Design reviews
  • Performance testing (verification)
  • Simulated use testing (validation and human factors and usability) (Page 5)

Missing Information:

The document explicitly states "Clinical Testing: N/A" (Page 6). This means there was no clinical study performed to evaluate the diagnostic accuracy or clinical effectiveness of the device when used by healthcare professionals. Therefore, the following requested information cannot be provided from this document:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

In summary: The provided 510(k) submission for the DR Systems Zero Download 3D Viewer (Z3D) focuses on demonstrating substantial equivalence through nonclinical testing (verification, validation, usability, risk analysis) and does not include details on acceptance criteria for clinical performance, clinical study results, or the other specific points requested about clinical validation.

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The DR Systems PACS, Release 6.1 is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. The DR Systems PACS interfaces to various storage and printing devices using DICOM or similar interface standards.

The DR Systems PACS displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MRI, CT, US, PET, DXA (bone densitometry), imaging, computed radiography, digital radiography, digitized films, digital photographs, mammographic images, and processed data from FDAcleared third party image processing systems, including FDA-cleared systems for computer-aided detection and advanced image processing (e.g. 3-D processed images such as those produced by Voxar Corp.).

Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.

The DR Systems Dominator Reading Station is a multi-modality PC-driven review workstation. It includes a color flat panel monitor and two or more high-resolution monitors, which may be high resolution CRT's or flat panel monitors. A standard keyboard is provided as well as a standard mouse. Optionally, a microphone may be attached.

DR Systems also provides components as described in the DR Systems User Guide, including:

• Ambassador Viewing Station Software typically used by referring doctors for viewing images, playing audio, or viewing reports, but not used for primary reading.
• Communicator Web Distribution Server.
• Guardian Archive System and optional DVD jukebox or EMC Centera archive.
• Catapult Technologist Workstation—for image and data input and editing as required.
• Universal Manager Workstations-primarily used by clerks for medical records and report management.

The DR Systems PACS, Release 6.1, provides the following features to the radiologist:

• DR Systems viewing software provides simple tools to enable display of any digital image at the same resolution as the initial acquired digital image, independent of the monitor matrix size.
• DR Systems provides several DICOM-compliant methods of lossless and lossy image compression (JPEG2000 and JPEG).
• The DR Systems PACS outputs DICOM medical image data to printers that adhere to appropriate regulatory standards.
• DR Systems archives medical imaging data in DICOM format on appropriate media (DVD, RAID servers, EMC Centera or other computer storage systems) that are designed to prevent data loss.
• DR Systems provides a software warning that identifies any image series where any image was not viewed prior to marking an examination as read, in order to prevent the reading physician from completing interpretation of an exam while inadvertently failing to view all images.
• DR Systems enables storage and reading of digitized images, including film-screen mammograms.

This document is a 510(k) Summary of Safety and Effectiveness for the DR Systems PACS, Release 6.1. It primarily focuses on demonstrating substantial equivalence to predicate devices for its intended use as a medical image and information management system, rather than presenting a study with specific acceptance criteria and performance metrics for a novel diagnostic algorithm.

Therefore, the requested information about acceptance criteria and a study proving a device meets them is not present in this document. The submission aims to show that the DR Systems PACS, Release 6.1, functions similarly to other PACS systems already on the market (Seno Advantage Windows Review Workstation and Sectra IDS5 Radiology Workstation).

Here's a breakdown of why the specific requested information cannot be provided from this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria for a diagnostic algorithm. It describes the features and functionalities of a PACS system.
2. Sample size used for the test set and the data provenance: Not applicable, as no diagnostic performance study is described. The "test and design considerations, and planned verification and validation testing processes" mentioned are generic for a PACS system's functionality and safety, not for a specific algorithmic performance test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no diagnostic performance study requiring ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. 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 applicable. This device is a PACS system, not an AI-powered diagnostic algorithm designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a PACS system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable, as this document does not describe a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission is for a Picture Archiving and Communication System (PACS) and focuses on its functional equivalence to existing PACS devices. It does not contain information related to the performance of a diagnostic algorithm against specific acceptance criteria, or details regarding study design, ground truth establishment, or reader studies.

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