The MAMMOMAT Inspiration PRIME system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.

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

Device Description

Mammomat Inspiration PRIME is a floor-mounted mammography system for screening, diagnostic and biopsy procedures on standing, seated or recumbent patients.

The Mammomat Inspiration PRIME provides optional gridless acquisition and progressive reconstruction. During progressive reconstruction a unique algorithm replicates the function of the grid. The grid slides back and no longer absorbs primary radiation, therefore less radiation dose is needed. The Mammomat Inspiration PRIME in gridless acquisition mode reduces radiation dose up to 30 percent.

The system consists of an examination stand with integrated, microprocessorcontrolled, high-frequency generator as well as a radiation shield with an optional height-adjustable control desk in which the Acquisition Workstation (AWS) can be integrated. A swivel arm contains the X-ray tube on the top end and the object table with the detector on the bottom end.

AI/ML Overview

The Siemens Mammomat Inspiration PRIME is a mammography system that introduces an optional gridless acquisition and progressive reconstruction algorithm designed to reduce radiation dose while maintaining image quality.

1. A table of acceptance criteria and the reported device performance

The provided text does not contain explicit acceptance criteria in a table format nor specific numerical performance metrics (e.g., sensitivity, specificity, AUC) for the device's diagnostic performance. Instead, it focuses on demonstrating that the new gridless acquisition mode with progressive reconstruction achieves dose reduction with equivalent image quality compared to the predicate device. The primary performance claim is dose reduction.

Key Claim: The modified Mammomat Inspiration Prime can lower dose up to 30 percent compared to the predicate (P030010/S006) with equivalent image quality.

Device Performance (as reported):

Dose Reduction: Up to 30% reduction in radiation dose in gridless acquisition mode.
Image Quality: Equivalent image quality to the predicate device, as evaluated with phantom testing and clinical image review.

2. Sample size used for the test set and the data provenance

The document explicitly mentions "clinical testing to quantify the potential of dose savings" (Section 10) and "clinical image review" (Section 8). However, it does not specify the sample size for the test set used in the clinical image review or the dose savings quantification. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that "clinical image review" was conducted (Section 8), implying expert evaluation. However, it does not specify the number of experts involved or their qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document mentions "clinical image review" but does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set results.

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

The submission describes a mammography system and its dose reduction technology, not an AI-based diagnostic tool intended to assist human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted or reported. The study focused on validating the image quality of the new gridless acquisition mode against a predicate device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device in question, Mammomat Inspiration PRIME, is a mammography system that produces images. The "new algorithm for progressive image reconstruction" is an integral part of the image generation process, replacing the physical scatter radiation grid. Its performance in terms of image quality and dose reduction is inherently tied to the system itself.

While the algorithm functions independently in reconstructing the image, the evaluation of "equivalent image quality" (Section 8) implies human interpretation of those images. Therefore, a standalone algorithm-only diagnostic performance (without human in the loop for interpretation) was not the focus of this submission, as the device's output (images) is still intended for human review. The claim is about the quality of the image produced by the algorithm, not the algorithm's diagnostic capabilities.

7. The type of ground truth used

For the clinical image review, "equivalent image quality" was assessed. This likely implies a consensus-based expert review of the diagnostic quality and clarity of the images produced by the new system compared to those from the predicate device. The document also mentions "phantom testing" (Section 8), which uses objective, known ground truths provided by a phantom. However, for the clinical aspect, no specific external ground truth (like pathology or outcome data) is explicitly mentioned; rather, it appears to be a comparative assessment of image quality by experts.

8. The sample size for the training set

The document does not mention any "training set" in the context of an AI/machine learning algorithm for diagnostic purposes. The "progressive image reconstruction" is described as a "unique algorithm" (Section 5) that replicates the function of a grid. While such algorithms might involve some form of internal parameter optimization, the submission does not detail its development or refer to a distinct training set in the conventional sense of machine learning for diagnostic tasks.

9. How the ground truth for the training set was established

As no training set is discussed or implied for an AI diagnostic algorithm, the question of how its ground truth was established is not applicable based on the provided text. The algorithm's function is to reconstruct images by identifying and correcting for scatter, not to make a diagnosis.

Summary

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K123520
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510(k) Summary: Mammomat Inspiration PRIME

Company:

Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355.

Date Prepared: June 11, 2013

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:

SIEMENS

Importer / Distributor: Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Establishment Registration Number: 2240869 Manufacturing Site: SIEMENS AG Sector Healthcare Henkestraße 127 91050 Erlangen Establishment Registration Number:

3004977335

2. Contact Person:

Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway D-02 Malvern, PA 19355 Phone: (610) 448 -3536 Fax: (610) 448-1787 Email: patricia.d.jones@siemens.com

3. Device Name and Classification:

Trade Name: Mammomat Inspiration PRIME Device: Full Field Digital, system, X-Ray Mammographic Requlation: Medical Specialty Radiology Review Panel Radiology Product Code MUE Submission Type 510(k) Regulation Number 892.1715 Device Class 2

4. Legally Marketed Predicate Device

Trade Name:	Mammomat Inspiration VB30
Device:	Full Field Digital, system, X-RayMammographic
Regulation:	Medical Specialty Radiology

JUN 1 1 2013

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SIEMENS

Review Panel Radiology Product Code MUE Submission Type 510(k) Requlation Number 892.1715 Device Class 2

ട്. Device Description:

Mammomat Inspiration PRIME is a floor-mounted mammography system for screening, diagnostic and biopsy procedures on standing, seated or recumbent patients.

6. Indication for Use:

The MAMMOMAT Inspiration PRIME system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.

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

7. Substantial Equivalence:

The Siemens Mammomat Inspiration PRIME is substantially equivalent to the commercially available Siemens Mammomat Inspiration P030010/S006.

X-ray generation and control used with the Mammomat Inspiration PRIME is identical to the Mammomat Inspiration with VB30. Detector TFT specifications and general image processing algorithms remain unchanged. The Acquisition Workstation (AWS) is identical.

8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

The modified Mammomat Inspiration Prime can lower dose up to 30 percent compared to the predicate (P030010/S006) with equivalent image quality as evaluated with phantom testing and clinical image review. The dose can be reduced as the scatter radiation grid, which has been commonplace up to now, is replaced by a new algorithm for progressive image reconstruction. The conventional scatter radiation grid absorbs scattered radiation to ensure image quality. But as it also absorbs part of the important primary radiation, higher dose is needed to obtain images of the desired quality. The new algorithm can identify the scatter-causing

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K123520
Page 3 of 3

SIEMENS

structures and can calculate a corrected image. Thus, the primary radiation can be completely used and high-quality images can be achieved with less dose.

9. Summary of Non-Clinical Tests:

The Siemens Mammomat Inspiration Prime complies with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Analvsis
Requirements Reviews
Design Reviews
Integration testing (System verification) .
Performance testing (Bench testing) .

10 Summary of Clinical Tests:

For the subject of this premarket submission, Siemens Mammomat Inspiration Prime, included clinical testing to quantify the potential of dose savings. This clinical is described in Section 15 of this premarket submission.

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 Inspiration is continually 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 Inspiration PRIME is intended for the same indications for use as the predicate Mammomat Inspiration VB30. The imaging properties (TFT with pixel size and number and image processing algorithms) have not been modified. It is Siemens opinion, that the Mammomat Inspiration PRIME is substantially equivalent to the Mammomat Inspiration P030010/S006.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three wing-like shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

Silver Spring, MD 20993-0002

Public Health Service

June 11, 2013

Ms. Patricia D. Jones Siemens Medical Solution, Inc. Technical Specialist, Regulatory Submissions 51 Valley Stream Parkway, E-50 MALVERN PA 19355

Re: K123520

Trade/Device Name: Mammomat Inspiration PRIME Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: May 31, 2013 Received: June 4, 2013

Dear Ms. Jones:

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. 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 is 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing 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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Page 2 - Ms. Jones

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

5 10(k) Number (if known): __K 123520

Device Name: Mammomat Inspiration PRIME

Indications for Use:

The Mammomat Inspiration system is intended for mammography exams. screening, diagnosis, and stereotactic biopsies under supervision of medical professionals.

Mammographic images can be interpreted by either hardcopy film or softcopy workstation.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ ANDIOR (Part 21 CFR 301 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Sm.h.p.)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K123520

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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.