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The MEDWS Software (MEDVIEWS, MEDMAMMO) is intended for selection, display, manipulation and media interchange of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing device using DICOM or similar interface standards.

Lossy compressed mammographic image are not intended for diagnostic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM for presentation images must be used.

The MEDWS Software (MEDVIEWS, MEDDIAG, MEDMAMMO) is typically used by trained professionals including but not limited to physicians, radiologists, nurses, medical technicians and assistants.

The MEDWS software range offers solutions for managing radiology images and reviewing them for diagnostic purposes. They are used in hospital or clinic radiology departments and in private medical imaging practices. They are used by radiologists for all functions and by technicians for functions not involving diagnoses (formatting for printing, CD burning, etc. ). A solution from the MEDWS software range is installed on a computer connected to the imaging network. The radiology table (modality) manages image acquisition and sends images over the local network to a console from the MEDWS range.

This document describes the MEDWS software, an image management, review, and display system for radiology images. It provides a substantial equivalence comparison to a predicate device, but it does not contain any information about specific acceptance criteria or a study proving the device meets those criteria, especially not regarding "diagnosing" or "reporting device performance" in the context of CAD.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) or quantitative performance metrics for the MEDWS software.

The acceptance criteria discussed relate to general software and medical device standards (e.g., DICOM conformance, ISO standards, IEC standards) and internal bench testing for functionalities like installation, configuration, data management, DICOM conversion/connectivity, and export. There are no performance metrics related to diagnostic accuracy or efficacy.

2. Sample Size for Test Set and Data Provenance:

No information is provided about a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The document states that "Every specification of the MEDWS software is validated by a bench test before release," but these are described as internal functional software tests, not clinical evaluations.

3. Number of Experts and Qualifications for Ground Truth:

No information is provided about experts used to establish ground truth. Since no diagnostic performance study is described, the concept of clinical ground truth as defined by experts is not applicable in this document's context.

4. Adjudication Method:

No information is provided about an adjudication method. This is relevant for studies involving human readers and ground truth, which are not present in this document.

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

No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, not on comparing performance with and without AI assistance or evaluating human reader improvement. The device itself (MEDWS) is described as an image management and viewing system, not an AI-powered diagnostic tool. Furthermore, the document explicitly states that the "Display of CAD results" and "Multiframe images breast MR CAD analysis And breast MR motion correction" capabilities of the predicate device are not present in MEDWS (specifically MEDVIEW/MEDDIAG).

6. Standalone (Algorithm Only) Performance Study:

No standalone performance study for an algorithm is mentioned. MEDWS is a software platform for image display and management, not a diagnostic algorithm itself.

7. Type of Ground Truth Used:

The document refers to "bench testing" to validate software specifications. The "ground truth" for these tests would be the expected functional outcome of the software (e.g., "does it install correctly?", "does it transfer DICOM objects successfully?"). This is distinct from clinical ground truth (e.g., pathology, outcomes data, expert consensus) used to evaluate diagnostic accuracy.

8. Sample Size for Training Set:

No information is provided about a training set since the device is not described as an AI/ML algorithm that requires training data for diagnostic tasks.

9. How Ground Truth for Training Set was Established:

As no training set is mentioned (see point 8), this information is not applicable.

Summary of what the document does provide regarding "performance":

The document focuses on:

• Non-clinical performance (bench testing): This involves validating software specifications against defined requirements (e.g., installation, configuration, data management, DICOM operations). This is a functional and technical assessment, not a clinical performance study.
• Substantial Equivalence: The primary "performance" argument is that the device's design, technology, functionalities, intended use, and performances (in a functional sense, e.g., how much RAM is needed, what modalities are supported) are similar to a legally marketed predicate device. Any differences are argued to have no impact on safety or efficacy.

Conclusion:

The provided text details the regulatory submission (510(k)) for the MEDWS software, emphasizing its substantial equivalence to a predicate device for managing and displaying medical images. It describes the software's functional capabilities and adherence to relevant standards. However, it does not include information about clinical acceptance criteria or a study demonstrating diagnostic performance, as the device's role is not a diagnostic algorithm but rather an image viewing and management system. The document explicitly notes the absence of CAD result display and CAD analysis capabilities in MEDWS compared to the predicate device, further indicating it's not a CAD system requiring diagnostic performance metrics.

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