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Unifi™ Workspace is a software application that is intended for use in receiving, manipulating, displaying, printing, and archiving mammography images as well as other medical images and data (e.g. US and MR). Images and data can be stored, communicated, and displayed within the system or across computer systems. Unifi Workspace provides various image processing and measurement tools to facilitate the interpretation of mammography X-ray, breast tomosynthesis, and other multimodality DICOM medical images and enable diagnosis. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA.

Unifi Workspace is typically used by trained professionals, including radiologists, surgeons, technologists, and clinicians and may provide information to be used for screening and diagnostic procedures.

Unifi™ Workspace is a multi-modality software application that can be used for processing and displaying mammography x-ray, breast tomosynthesis, and other multimodality DICOM medical images for reference and diagnostic use by physicians and medical professionals.

The provided text is a 510(k) summary for Hologic's Unifi™ Workspace v1.0.0. It describes the device, its intended use, and a comparison to predicate devices, but it explicitly states that "No clinical studies have been performed." Therefore, there is no information on acceptance criteria for device performance proven by a study, as understood in the context of clinical or performance validation studies.

However, the document does mention "system design control verification and validation tests" and "bench testing, including functional testing and usability testing." While these are not clinical studies proving device performance against specific clinical acceptance criteria, they are the basis of the substantial equivalence claim.

Based on the available text, here's a breakdown of what can be extracted, acknowledging the absence of a performance study proving clinical acceptance criteria:

Absence of Clinical Performance Study:
The document explicitly states: "No clinical studies have been performed." This means that the device's performance against clinical acceptance criteria (e.g., diagnostic accuracy, sensitivity, specificity) as typically proven by large-scale clinical trials or comparative effectiveness studies with human readers, is not available in this filing. The substantial equivalence claim is based on non-clinical testing, functional testing, and usability testing, comparing the new device's features and performance to predicate and reference devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical studies were performed, there are no acceptance criteria for clinical performance metrics (like sensitivity, specificity, or reader accuracy). The acceptance criteria are implicitly related to the functional and usability performance of the software, demonstrating that it operates as intended and is comparable to the predicate device.

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

The document does not specify a "test set" in the context of a clinical performance study with patients/images. The testing described is "system design control verification and validation tests" and "bench testing."

• Sample Size: Not applicable in the context of a clinical test set. The software itself was tested.
• Data Provenance: Not applicable. If there were images used for functional testing, their provenance is not mentioned, as it's not a clinical study.

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

Not applicable, as no clinical performance study with a "test set" requiring ground truth establishment by experts was performed.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical performance study was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies have been performed." Therefore, there is no effect size of human readers improving with or without AI assistance. The device is a "Picture archiving and communications system," primarily for displaying and manipulating images, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.

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

Not applicable in the context of a diagnostic algorithm's performance. The device is a workstation software. Its performance relates to its ability to display, process, and manage medical images effectively, not to provide an independent diagnostic output.

7. The Type of Ground Truth Used:

Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the verification and validation (V&V) of this workstation software would be its functional specifications and compliance with industry standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/Machine Learning diagnostic algorithm that requires a "training set" of medical images to learn from. It is a software application for image management and display.

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

Not applicable, as there is no training set for this type of software device.

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