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MAMMOVISTA B.smart is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. MAMMOVISTA B.smart provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography and digital breast tomosynthesis datasets, as well as other modalities of breast images.

Device Description

MAMMOVISTA B.smart is an optional software application for the Siemens Healthineers syngo.via platform (K191040). MAMMOVISTA B.smart is an image viewing and processing software environment dedicated to breast image display. It is designed to provide the performance required for the high data volume of digital tomosynthesis and the display of multi-modality breast images, such as those from MRI and ultrasound. Individual workflows can be adapted to either screening or diaqnostic purposes.

MAMMOVISTA B.smart runs on a PC and can be used for Mammography image review together with monitors cleared for Mammography diagnostics. The software solution provides for the display of DICOM compatible information, such as breast density and CAD (Computer Aided Diagnostics) markers.

AI/ML Overview

The provided text describes MAMMOVISTA B.smart (VB70), a software device for mammography image review. However, it does not explicitly state acceptance criteria or a dedicated study proving performance against such criteria. The submission is a 510(k) premarket notification for substantial equivalence, comparing the new VB70 version to a predicate device, MAMMOVISTA B.smart VB60 (K212621).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria or device performance metrics for the VB70 version beyond a feature-by-feature comparison to the predicate device. The performance is described in terms of functional equivalence and safety.

Feature/Criterion	Acceptance Criteria (Implied)	Reported Device Performance (VB70)
Functional Equivalence	Functions identically to predicate device (VB60).	"MAMMOVISTA B.smart VB70 has the same indications for use as the predicate device. ...The new software design was completed in accordance with Quality Management System Design Controls comparable to the processes available for the predicate device. The scope of internationally recognized standards compliance is the same as it was for the predicate device." "Verification and validation testing demonstrate that the MAMMOVISTA B.smart performs as intended."
Safety	No new safety risks compared to predicate device.	"It is Siemens' opinion that the MAMMOVISTA B.smart does not introduce any new potential safety risks and is substantially equivalent to the MAMMOVISTA B.smart VB60." Risk analysis completed and controls implemented.
Compliance with Standards	Conforms to relevant software and medical device standards.	Complies with IEC 62366-1 2015 Ed 1.0, IEC 62304 2015, Ed.1.1, and NEMA PS 3.1 - 3.20 2016.
DICOM Compatibility	Compatible with DICOM 3.0 and various modalities.	Same as predicate, supports MG, MG Tomo, MR, CR, CT, DR, NM, US, SC, PET.
Display of CAD Markers	Ability to display third-party CAD markers.	Yes, same as predicate.
Display/Processing of DBT	Ability to display and process Digital Breast Tomosynthesis images.	Yes, same as predicate.
Display of Breast Density	Ability to display breast density values.	Yes, same as predicate.
Configuration/Settings	Workflow, layout, image viewing, and tool settings function as intended. Minimal impact on safety/effectiveness for new settings.	Includes automatic study grouping, diagnostic display responsibility, client compatibility check, image rendering performance, layout settings, ReportFlow settings, custom image text settings, image navigation settings, image viewing preferences, image tool settings, workflow settings, screening case detection, double blind reading. "The new settings do not impact safety and effectiveness."
MR Support	MR Layouts and functionality (e.g., color overlay, time curve analyzer) function as intended. Minimal impact on safety/effectiveness for new MR features.	New MR layouts (MR.Kaiser, MR.MPR, MR.DWI, MR.FollowUp), color overlay, time curve analyzer. "The new MR features do not impact safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "Non-clinical tests (integration and functional) were conducted on the MAMMOVISTA B.smart during product development." It further notes, "Siemens did not conduct any clinical tests for the subject device." Therefore, the "test set" in this context refers to software testing and verification/validation, not a clinical data set for performance evaluation in a medical context.

Sample Size for Test Set: Not specified, as it refers to internal software testing, not a clinical population.
Data Provenance: Not applicable for a software-only 510(k) submission based on substantial equivalence and non-clinical testing. No patient data or clinical images are mentioned as being part of a "test set" for performance evaluation in the clinical sense.

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

Not applicable. This was a non-clinical software verification and validation study, not a clinical performance study requiring expert ground truth for medical diagnoses.

4. Adjudication Method for the Test Set:

Not applicable. This was a non-clinical software verification and validation study, not a clinical performance study involving human adjudication of medical findings.

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:

No. The document explicitly states: "Siemens did not conduct any clinical tests for the subject device." The device is a "softcopy review environment" that provides "visualization and image enhancement tools to aid a qualified radiologist," meaning it's a viewing workstation, not an AI or CAD device that provides interpretations or assists directly with diagnostic accuracy in a quantifiable way like an AI algorithm.

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

No. The device is a viewing and processing software. It is not an algorithm designed to provide standalone diagnostic interpretations. Its purpose is to "aid a qualified radiologist in the review" of images.

7. The Type of Ground Truth Used:

Not applicable. As a software viewing platform, the concept of "ground truth" (pathology, expert consensus, outcomes data) for its own performance is not directly relevant. Its performance is related to its ability to display images correctly, adhere to DICOM standards, and provide tools as specified, which are verified through non-clinical software testing.

8. The Sample Size for the Training Set:

Not applicable. This device is a software viewing platform, not an AI/Machine Learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set mentioned or implied for this type of device.

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K Number

K212621

Device Name

MAMMOVISTA B.smart

Manufacturer

Siemens Medical Solutions USA, Inc.

Date Cleared

2021-11-12

(86 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K191040,K123420

Intended Use

Device Description

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a medical device (MAMMOVISTA B.smart) and primarily focuses on establishing substantial equivalence to a predicate device.

Specifically, the document states:

"Non-clinical tests (integration and functional) were conducted on the MAMMOVISTA B.smart during product development. The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the software specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence." (page 7)
"Siemens did not conduct any clinical tests for the subject device." (page 7)

Therefore, I cannot provide:

A table of acceptance criteria and reported device performance.
Sample size and data provenance for a test set.
Number and qualifications of experts for ground truth.
Adjudication method for a test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
Information on a standalone performance study, as clinical tests were not conducted.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document only states that "all the software specifications have met the acceptance criteria" based on non-clinical (integration and functional) tests and risk analysis, but it does not detail those criteria or the specific results of these tests. It explicitly states no clinical tests were performed.

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