The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be interpreted by either hard copy film or soft copy workstation.

With Biopsy Option:

The InSpect feature for MAMMOMAT Revelation with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.

Device Description

MAMMOMAT Revelation is a floor-mounted, full field digital mammography system for screening, diagnostic, and biopsy procedures on standing, seated, or recumbent patients. The system consists of an examination stand with x-ray generator, a gantry with tube housing assembly, and mammography support table, including detector and an acquisition workstation with a radiation shield. The MAMMOMAT Revelation comes with a variety of compression plates and a biopsy attachment for diagnostic adjunct procedures.

The MAMMOMAT Revelation features an updated system software to VC20, including new detector software for faster system calibration, and improvements to the contrast enhanced mammography feature and biopsy workflow. Improvements include adjustments to the image processing for contrast enhanced mammography to present a more homogeneous image. The biopsy attachment was complemented with a spacer plate to be used for easier access to the biopsy region.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the MAMMOMAT Revelation device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Detector Characteristics	Same or better than predicate (as described in FDA's Class II Special Controls Guidance Document: Full-Field Digital Mammography System)	Passed
Dual Energy Imaging	Image quality equivalent to images acquired with VC10	Passed
Targeting Accuracy (Biopsy Device)	The needle tip must be no more than +/-1 mm in x, y, z direction from the selected target point.	Within 1 mm of target
Biopsy Procedure with Spacer Plate	Same results with and without spacer plate	Passed
Cleaning of the Spacer Plate	According to AAMI TIR 30 and AAMI ST58	Passed
Clinical Image Evaluation (FFDM)	Acceptable quality for mammographic usage (substantially equivalent to predicate device images)	Determined to be substantially equivalent to predicate device

2. Sample Size and Data Provenance for Test Set

FFDM Clinical Image Evaluation: The image sets consisted of 8 FFDM cases (including one case with diagnostic images).
DBT Biopsy Cases: Three DBT biopsy cases with the new spacer plate.
Contrast Enhanced Mammography Cases: 4 contrast enhanced mammography cases.
Data Provenance: Not explicitly stated, but given that the study was conducted by Siemens and submitted to the FDA, it is likely internal data, possibly from multiple sites contributing to the case collection. It is considered retrospective in the sense that existing cases were used for evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Images for dual energy imaging were "evaluated by Radiologists." The clinical image evaluation was reviewed by "expert radiologists." The exact number of radiologists is not specified, nor are their specific qualifications (e.g., years of experience), but they are described as "expert radiologists."

4. Adjudication Method for the Test Set

The text does not specify a formal adjudication method (like 2+1 or 3+1 consensus). It simply states that images were "evaluated by Radiologists" and "reviewed by expert radiologists."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done to evaluate human reader improvement with AI assistance. The study described focuses on demonstrating the substantial equivalence of the device's image quality and performance compared to its predicate, primarily through technical tests and a clinical image evaluation by radiologists. This submission does not appear to involve an AI component that would assist human readers in interpretation.

6. Standalone (Algorithm Only) Performance Study

A standalone algorithm performance was not the primary focus of the clinical evaluation described here. The evaluation of FFDM cases and dual energy images involved human radiologists determining image quality and equivalence. Some tests, like "Detector characteristics" and "Targeting accuracy," could be considered standalone performance evaluations of specific aspects of the device's capabilities.

7. Type of Ground Truth Used

For the clinical image evaluations, the ground truth was established by expert consensus/review from radiologists. The "acceptable quality for mammographic usage" and "image quality equivalent to images acquired with VC10" were determined by these experts.
For technical tests like "Targeting accuracy," the ground truth was established by physical measurement (e.g., measuring the needle tip's deviation from the target point with a phantom).

8. Sample Size for the Training Set

The document describes modifications to the MAMMOMAT Revelation device, including updated system software (VC20) with new detector software and improvements to image processing. It does not explicitly mention a "training set" in the context of machine learning or AI algorithm development for the device itself. Therefore, the concept of a training set for an AI algorithm is not directly applicable to the information provided regarding this device's submission.

9. How the Ground Truth for the Training Set Was Established

As a training set for an AI algorithm is not explicitly mentioned or relevant in the provided context, the method for establishing its ground truth is not applicable. The improvements mentioned (e.g., "improvements to the contrast enhanced mammography feature and biopsy workflow") suggest engineering and software development rather than machine learning model training.

Summary

{0}------------------------------------------------

June 12, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Siemens Medical Solutions USA, Inc. % Mr. Martin Rajchel Sr. Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355

Re: K193166

Trade/Device Name: MAMMOMAT Revelation Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: May 15, 2020 Received: May 18, 2020

Dear Mr. Rajchel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

{1}------------------------------------------------

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K193166

Device Name MAMMOMAT Revelation

Indications for Use (Describe)

With Biopsy Option:

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

510(k) Summary: MAMMOMAT Revelation-K193166

Siemens Medical Solutions USA. Inc. Company: 40 Liberty Boulevard, 65-1A Malvern, PA 19355

May 13, 2020 Date Prepared:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

1. General Information:

Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869

Location of Manufacturing Site

Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335

2. Contact Person:

Martin Rajchel Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, US

3. Device Name and Classification:

MAMMOMAT Revelation Trade Name: Classification Name: Full Field Digital, System, X-Ray Mammographic Classification Panel: Radiology Classification Regulation: 21 CFR §892.1715 Device Class: 2 Product Code: MUE

4. Legally Marketed Predicate Device

Trade Name:	MAMMOMAT Revelation
510(k) #:	K173408
Classification Name:	Full Field Digital, System, X-Ray Mammographic
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1715
Device Class:	2
Product Code:	MUE

5. Device Description:

MAMMOMAT Revelation is a floor-mounted, full field digital mammography system for screening, diagnostic, and biopsy procedures on standing, seated, or recumbent patients.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.

The system consists of an examination stand with x-ray generator, a gantry with tube housing assembly, and mammography support table, including detector and an acquisition workstation with a radiation shield. The MAMMOMAT Revelation comes with a variety of compression plates and a biopsy attachment for diagnostic adjunct procedures.

6. Indication for Use:

The MAMMOMAT Revelation is intended to be used for mammography exams. screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.

The Mammography images can be interpreted by either hard copy film or soft copy workstation.

With Biopsy Option:

7. Substantial Equivalence:

The Siemens MAMMOMAT Revelation with VC20 is substantially equivalent to the commercially available Siemens MAMMOMAT Revelation with VC10 (K173408).

Attributes	Subject deviceMAMMOMAT RevelationVC20	Predicate deviceMAMMOMAT RevelationVC10, K173408	Remarks
Indication forUse	The MAMMOMAT Revelationis intended to be used formammography exams,screening, diagnostics,biopsies and dual energyprocedures under thesupervision of medicalprofessionals.The Mammography imagescan be interpreted by eitherhard copy film or soft copyworkstation.With Biopsy Option:The InSpect feature forMAMMOMAT Revelation withHD Biopsy options isintended to provide digital X-ray images of core biopsyspecimens in order to allow	The MAMMOMAT Revelationis intended to be used formammography exams,screening, diagnostics,biopsies and dual energyprocedures under thesupervision of medicalprofessionals.The Mammography imagescan be interpreted by eitherhard copy film or soft copyworkstation.With Biopsy Option:The InSpect feature forMAMMOMAT Revelation withHD Biopsy options isintended to provide digital X-ray images of core biopsyspecimens in order to allow	Same
Attributes	Subject deviceMAMMOMAT RevelationVC20	Predicate deviceMAMMOMAT RevelationVC10, K173408	Remarks
	rapid verification that thecorrect tissue has beenexcised with the biopsyprocedure.	rapid verification that thecorrect tissue has beenexcised with the biopsyprocedure.
Product Code	MUE	MUE	Same
System configuration
X-ray Stand	Floor mounted X-ray system	Floor mounted X-ray system	Same
X-rayGenerator	5 kW	5 kW	Same
kV range	23kV to 49kV	23kV to 49kV	Same
X-ray Tube	Same tube	Same tube	Same
Collimator	Automatic for all sizes	Automatic for all sizes	Same
Compressionunit	Automatic and manualoperation	Automatic and manualoperation	Same
Object table	Carbon fiber mammographysupport system	Carbon fiber mammographysupport system	Same
Detector	LMAM2v2	LMAM2v2	Same
Detectorsoftware	PEGASUS	MOSAIC	Improveddetectorhandling
Detectormanufacturer	Anrad	Anrad	Same
Detector TFT	Amorphous Silicon (a-Si)	Amorphous Silicon (a-Si)	Same
Detector size	24 cm x 30 cm	24 cm x 30 cm	Same
Array size	2816 x 3584	2816 x 3584	Same
Pixel size	85 µm x 85 µm	85 µm x 85 µm	Same
Grid	Reciprocating 5:1 ratio	Reciprocating 5:1 ratio	Same
Magnificationtable	Magnification 1.5 and 1.8	Magnification 1.5 and 1.8	Same
Biopsyattachment	Yes	Yes	Same
tomosynthesisguided biopsy	Yes	Yes	Same
Monitor/Display	19" and 21" TFT display	19" and 21" TFT display	Same
Software controlled functions
Systemsoftware	VC20	VC10	Improvedfunctionality
TiCEM	Dual energy imaging	Dual energy imaging	Improvedimageprocessing
AECCalculation	AEC calculation is done inthe acquisition workstation	AEC calculation is done inthe acquisition workstation	Same
OperatingSystem	Windows 10	Windows 10	Same
Imageprocessingalgorithms	Opview	Opview	Same
DICOM	Yes	Yes	Same

Table 1: Comparison of the Subject to the Primary Predicate

{5}------------------------------------------------

Image /page/5/Picture/2 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.

1. Summary of Technological Characteristics of the Su with the Predicate Devices:
  The MAMMOMAT Revelation is based on the same mechanical stand as the predicate device. X-ray generation and control are also the same. The collimator, compression unit, and AEC technology are the same. The image processing algorithms for FFDM are identical to those of the predicate. There are no new features but improvements to the detector handling, biopsy workflow, and dual energy image processing.

9. Summarv of Non-Clinical Tests:

The Siemens MAMMOMAT Revelation was tested and complies with the voluntary standards listed in the table below:

Table 2: Non-clinical performance testing

Reference Number, Date and Title of Standard

IEC 60601-1: 2012, Ed 3.1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2: Ed 4, 2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC 60601-1-3 Ed 2.1, 2013, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC 60601-2-28 Ed 2.0, 2010, Medical electrical equipment - Part 2: Particular requirements for the safety and essential performance of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

IEC 60601-2-45: 2015, Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

IEC 62366: 2015, Ed 1.0 Medical devices - Application of usability engineering to medical devices

ISO 14971:2007, Medical devices - application of risk management to medical devices

IEC 62304: 2015-06 Edition 1.1, Medical device software - Software life cycle processes

ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

NEMA PS 3.1 - 3.20: 2016, Digital Imaging and Communications in Medicine (DICOM) Set

IEC 60336: 2005, Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots

In addition, the following tests were conducted:

Test	Objective	Test Method	AcceptanceCriteria	Results
Detectorcharacteristics	Ensure non-inferiority topredicate	As described inFDA's Class IISpecial ControlsGuidance Document:Full-Field DigitalMammographySystem	Same or betterthan predicate	Passed

Table 3: Summary of Tests

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.

Dual energyimaging	Ensurediagnosticimagequality	Images have beenevaluated byRadiologists	Image qualityequivalent toimagesacquired withVC10	Passed
Targetingaccuracy	Ensureaccuracy ofthe biopsydevice	Accuracy tests withphantom andcalibration needle.	The needle tipmust be nomore than +/-1mm in x, y, zdirection fromthe selectedtarget point.	Within 1mm oftarget
Biopsyprocedurewith spacerplate	Ensuresafety andeffectivenessof biopsy	Workflow tests withand without spacerplate	Same resultswith andwithout spacerplate	Passed
Cleaning ofthe spacerplate	Ensureeffectivenessof cleaningprocedure	Cleaning anddisinfection validation	According toAAMI TIR 30andAAMI ST58	Passed

The following quality assurance measures were applied to the development of the system:

Risk Analvsis .
Requirement Specification Reviews ●
Design Reviews
Integration testing (System verification) ●

10. Summary of Clinical Tests:

Siemens conducted a clinical image evaluation to determine if the FFDM images, when reviewed by expert radiologists, are of acceptable quality for mammographic usage. The imaqe evaluation was carried out according to the Class II Special Controls Guidance Document: Full-Field Digital Mammography System. The image sets consisted of 8 FFDM cases including one case with diagnostic images; three DBT biopsy cases with the new spacer plate; and 4 contrast enhanced mammography cases. It was determined that the images from the subject device are substantially equivalent to those from the predicate device.

11. General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features, including visual and audible warnings, are incorporated into the system design. In addition, the MAMMOMAT Revelation is continuously monitored and if an error occurs the system functions will be blocked, and an error message will be displayed.

Furthermore, the operators are health care professionals familiar with and responsible for the x-ray examinations to be performed. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and all equipment is subject to final performance testing.

12. Conclusion as to Substantial Equivalence:

The MAMMOMAT Revelation with VC20 has the same intended use, fundamental scientific technology, and performance characteristics as the predicate, MAMMOMAT

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.

Revelation with VC10 (K173408). Therefore, the MAMMOMAT Revelation with VC20 is substantially equivalent to the predicate MAMMOMAT Revelation with VC20.

13. Guidance documents

The following FDA quidance documents were utilized in this Premarket Notification:

. Content of Premarket Submission for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document Issued on October 2, 2014
. Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issued on July 11, 2016
Guidance for Industry and Food and Drug Administration Staff Class II Special . Controls Guidance Document: Full-Field Digital Mammography System Document issued on March 27, 2012
Guidance for Industry and FDA Staff Guidance for the Content of Premarket . Submissions for Software Contained in Medical Devices Document issued on May 11, 2005
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for . Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issued on September 14, 2018.
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications . - Guidance for Industry and Food and Drug Administration Staff Document issued on July 28, 2014

Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.