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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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