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.

Device Description

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.

AI/ML Overview

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.

Summary

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Siemens Medical Solutions, Inc Traditional 510(k) for MammoReportPlus

Ko42868

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MammoReportPlus JAN - 6 2005 510(k) Summary

Product Name:	MammoReportPlus
Product Classification Name:	Picture Archiving and Communications System
Product Classification Code:	LLZ CFR Section: 892.2050
Classification Panel:	Radiology Class II
Manufacturer:	Siemens AGMedical SolutionsHenkestrasse 127D-91052 ErlangenGermany
Contact Person:	Debbie Peacock, Technical Specialist Regulatory AffairsTelephone: (610) 448-1773Fax: (610) 448-1787
Date Prepared:	October 15, 2004

MammoReport" ws soft copy review station (originally a part of the Predicate Device: overall system, P030010, Siemens MAMMOMAT Novation FFDM system cleared on 8/20/04).

Device Description: 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.

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Ko42 868

Siemens Medical Solutions, Inc Traditional 510(k) for MammoReportPlus

The minimum computer requirements are:

. Windows XP Operating system
. Intel CPU with a clock rate of 2.2 GHz or greater
. 2.0 GB RAM or greater
. 70 GB hard drive or greater, operation at 160 Mbs or greater
CD-ROM/R/RW, DVD
10/100/1000 Base Network interface .

Summary of Technological Characteristics of the Devices Compared to the Predicate

The proposed syngo MammoReport" 108 soft copy review station combines the same ability for multimodality viewing with the Windows based operating system using a Siemens syngo graphical user interface (GUI) as is contained in the cleared predicate Leonardo Multimodality Workstation (K040970).

In addition, the proposed device contains the same ability to receive and display CAD markers from an approved device, as well as the ability to view multimodality and mammography images as the cleared predicate device, the Sectra IDS5 Workstation (K040376).

In addition to the cleared CRT monitors previously described in the original Siemens Mammomat Novation PMA submission, P030010, any FDA cleared TFT displays may be used as described in this PMN.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 6 2005

Ms. Debra Peacock Technical Specialist, Regulatory Submissions Siemens Medical Systems, Inc. 51 Valley Stream Parkway, E-50 MALVERN PA 19355

Re: K042868 Trade/Device Name: MammoReportPlus Softcopy Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 9, 2004 Received: December 10, 2004

Dear Ms. Peacock:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807), labeling / to 5 requirements, moraling practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter with cation. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you atte office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours,

Nancy C. Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use 1.1

510(k) Number (if known): K042868

Device Name: MammoReport\textsuperscript{Plus} Softcopy Workstation

Indications for Use

The MammoReport"]]s 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.

Trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants, typically use the MammoReport"his

(Please do not write below this line - continue on another page if needed)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042868
Prescription Use V OR Over-The-Counter Use __
(Per 21 CFR 801.109)

CONFIDENTIAL

Regulation Number and Section

§ 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).