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MammoWorkstation is designed to assist radiologists in conducting primary diagnostic review for diagnostic and screening mammography through flexible and interactive manipulation of multi-modality softcopy images.

It provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment.

Mammo Workstation is designed to give easy and economic access to and display of multimodality softcopy images, structured reports, and CAD results through interfaces to various image storage devices using DICOM or similar interface standards. It supports creation of structured reports according to the DICOM breast imaging report templates.

Mammo Workstation supports teleradiology and teleconferencing providing access to multimodality softcopy images and structured reports in multiple locations within and outside the hospital.

Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography.

Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.

All images sent to or imported in the Mammoworkstation must conform to regulatory requirements. Image quality must conform with applicable quality guidelines. All modalities must be certified for soft-copy reading.

The Mammo Workstation is a medical image review workstation software for diagnostic and screening mammography.

Mammoworkstation has the capability to review Digital Breast Tomosynthesis (DBT) images that are compatible with DICOM Breast Tomosynthesis Image Storage.

It is a software product.

The provided document is a 510(k) Premarket Notification Submission for the GE Healthcare MammoWorkstation. It describes the device's intended use and substantial equivalence to predicate devices. However, the document explicitly states that "The subject of this premarket submission, MammoWorkstation, did not require clinical studies to support substantial equivalence."

Therefore, the information required to populate the acceptance criteria and study details for device performance is not available in the provided text. The submission relies on non-clinical tests (risk analysis, requirements reviews, design reviews, various levels of testing like unit, integration, performance, safety, and simulated use testing) to demonstrate substantial equivalence to its predicate devices.

Here's a summary of what can be extracted based on the prompt's requirements, with explicit notation of what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not provided. The document states that "MammoWorkstation, did not require clinical studies." Therefore, there is no test set with clinical data to report. Non-clinical testing was performed (e.g., unit, integration, performance, safety, simulated use testing) but details on specific test sets (e.g., number of images, type of data) are not included.

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

• Not applicable/Not provided. As no clinical studies were performed requiring a test set with ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. No clinical studies or test sets requiring expert adjudication were performed.

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:

• Not done. The document explicitly states "did not require clinical studies." This type of study would be a clinical study. The device is a "Medical imaging software" that is a "workstation" for review and analysis, not an AI CAD system claiming to improve human reader performance directly.

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

• Not applicable/Not provided. Since this is a workstation software and not an AI algorithm for autonomous detection/diagnosis, a standalone performance study in that context would not be relevant. The submission focuses on the functionality and safety of the workstation itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable/Not provided. No clinical ground truth was established as no clinical studies were deemed necessary.

8. The sample size for the training set:

• Not applicable/Not provided. As no AI/CAD algorithm (that would require a training set) is the primary subject of clinical evaluation here. The device is a workstation.

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

• Not applicable/Not provided. No training set for an AI algorithm was used for clinical evaluation.

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MammoWorkstation is designed to assist radiologists in conducting primary diagnostic review for diagnostic and screening mammography through flexible and interactive manipulation of multi-modality softcopy images.

It provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment.

MammoWorkstation is designed to give easy and economic access to and display of multi-modality softcopy images, structured reports, and CAD results through interfaces to various image storage devices using DICOM or similar interface standards. It supports creation of structured reports according to the DICOM breast imaging report templates.

MammoWorkstation supports teleradiology and teleconferencing providing access to multi-modality softcopy images and structured reports in multiple locations within and outside the hospital.

Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography.

Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.

The MammoWorkstation is a medical image review workstation software for diagnostic and screening mammography. It is a software product. The product consists of features that allow the qualified medical professional to review patient medical images and to apply tools to cover the relevant aspects of an efficient review workflow. In addition, the system supports creation of report documents.

The provided text describes the "MammoWorkstation" device and its 510(k) summary. However, it does not contain any information about acceptance criteria, device performance metrics, or a study proving its conformance to such criteria.

The document is a regulatory submission for a medical device (MammoWorkstation) seeking clearance from the FDA. It focuses on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the requested tables and details. All the requested points (1-9) would require a detailed performance study, which is absent in this 510(k) summary.

The document primarily states:

• The product is a medical imaging software for diagnostic and screening mammography.
• It provides image review, manipulation, analysis, post-processing, and printing capabilities.
• It supports teleradiology and teleconferencing.
• It is developed according to ISO 13485:2003, IEC 62304, and ISO 14971, and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
• Its intended use and technological characteristics are substantially equivalent to predicate devices (Cedara I-ReadMammo, Sectra Workstation IDS5/mx.net, GE Healthcare Centricity Radiology RA600).
• Differences lie in higher specialization for mammograms, structured report capabilities aligned with DICOM breast imaging templates, and user interface/automation features (e.g., automatic hanging protocol).

This type of regulatory submission often relies on a review of software development processes, verification and validation activities (which might include internal testing), and comparison to existing devices, but it typically does not present a detailed clinical or technical performance study with quantifiable acceptance criteria and results as you've requested for AI/CAD devices.

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