Search Results

The MammoReport\textsuperscript{Plus} is a medical diagnostic workstation for viewing, manipulation, communication, reporting and storage of medical images and data on exchange media including mammography images. It interfaces to various image storage and printing devices using DICOM or similar interface standards.

The MammoReport 145 used with FDA cleared monitors may be used by trained physicians for display, manipulation and interpretation of lossless compressed or noncompressed mammography images and diagnostic mammography, as well as any other DICOM multi-modality image. CAD markers created by FDA approved devices may be displayed.

The MammoReport" is essentially a software product. The software is used to accept images and CAD markers, directly intended for display (e.g. DICOM MG for presentation). The MammoReport"148 is a multi-modality review workstation used for presentation and manipulation of medical images including digital mammography images. It includes two high-resolution gray scale monitors (FDA approved/cleared for Mammography), or any FDA-cleared mammography monitor, 3button mouse, keyboard and keypad. The system will use lossless compression or no compression at all when displaying mammography images.

The provided documentation for the Siemens MammoReportPlus (K042868) is a 510(k) summary and clearance letter for a Picture Archiving and Communications System (PACS) workstation. It focuses on demonstrating substantial equivalence to predicate devices for viewing and manipulating medical images, including digital mammography.

Crucially, this submission does not contain a study that establishes acceptance criteria for device performance related to diagnostic accuracy or clinical effectiveness, nor does it report such performance metrics. The device is a display and manipulation workstation, not an AI or CAD diagnostic tool itself. The clearance is based on its ability to display images and CAD markers from other FDA-approved devices.

Therefore, based on the provided text, I cannot generate the requested table and study details as they are not present in this 510(k) submission.

Here's a breakdown of why the requested information cannot be extracted:

• Acceptance Criteria & Reported Performance (Table): The document does not define performance metrics like sensitivity, specificity, or FROC curves for the MammoReportPlus itself, as it is a viewing workstation. Its "performance" is implicitly tied to its ability to display images accurately and functionally, mirroring predicate devices.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (for diagnostic performance): These aspects are relevant for evaluating a diagnostic AI algorithm or a CAD system. They are not applicable to a PACS workstation like MammoReportPlus. The document does mention the display of "CAD markers created by FDA approved devices," but it does not evaluate the performance of those CAD markers or the workstation's impact on human readers' diagnostic accuracy.
• Training Set Sample Size & Ground Truth: Similarly, since this is not an AI algorithm, there is no "training set" in the context of diagnostic performance.

Summary of available information:

• Device Name: MammoReportPlus Softcopy Workstation
• Product Classification: Picture Archiving and Communications System
• Classification Code: LLZ, 21 CFR 892.2050 (Radiology Class II)
• Intended Use: Viewing, manipulation, communication, reporting, and storage of medical images and data, including mammography images. Used by trained professionals (physicians, radiologists, nurses, medical technicians, assistants) with FDA cleared monitors for display and interpretation of lossless compressed or non-compressed mammography and other DICOM multi-modality images. Displays CAD markers from FDA approved devices.
• Predicate Devices:
  • Siemens MAMMOMAT Novation FFDM system (P030010) - mammoReport was originally part of this overall system
  • Leonardo Multimodality Workstation (K040970) - for multimodality viewing with Windows OS and Siemens syngo GUI
  • Sectra IDS5 Workstation (K040376) - for receiving and displaying CAD markers, and viewing multimodality/mammography images
• Technological Characteristics: The device is a software product combining multimodality viewing capabilities, a Windows-based operating system with a Siemens syngo graphical user interface (GUI), and the ability to receive and display CAD markers from approved devices.
• Monitors: Uses two high-resolution gray scale monitors (FDA approved/cleared for Mammography) or any FDA-cleared mammography monitor, including TFT displays.
• Compression: Uses lossless compression or no compression for displaying mammography images.

In essence, the 510(k) for MammoReportPlus demonstrates that it is substantially equivalent to existing PACS workstations in its ability to securely and accurately display and manipulate medical images, including those from mammography, and to display CAD markers generated by other approved diagnostic tools. It does not provide data on the diagnostic performance of the workstation itself or its impact on reader performance.

Ask a specific question about this device