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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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Prima is a software application that is intended for use in receiving, processing, 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. Prima 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.

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

Prima is a software application that is intended for use in receiving, processing, 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. Prima 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.

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

The provided text is a 510(k) summary for a Picture Archiving and Communication System (PACS) software called "Prima." It declares substantial equivalence to predicate devices but does not contain information about specific acceptance criteria, performance studies, or clinical trial data as requested. The summary mentions that the performance of the software was tested in accordance with Hologic's design control procedures to demonstrate intended performance and that testing was successfully conducted, and demonstrates that Prima meets all of its functional requirements and specifications. However, it does not provide details about these tests.

Therefore, I cannot fulfill your request for the specific acceptance criteria and study details. The document focuses on regulatory equivalence rather than detailed performance metrics.

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Mammography Prior Enhancement (MPE) is a software application intended to enhance the appearance of prior non-Hologic digital mammography x-ray images so that they more closely resemble Hologic digital mammography images. MPE processed images are intended for comparison purposes only and cannot be used for primary diagnosis.

MPE runs on a Windows-based computer. Results can be displayed on a workstation capable of displaying mammography x-ray images, such as Hologic's SecurView® DX workstation, Product Code LLZ, CFR 892.2050 (K103385)

MPE is a software application that runs on a Windows server or softcopy display workstation, such as SecurView DX (K103385). MPE processes (manipulates) prior GE digital mammography images so that they will appear similar to Hologic digital mammography images. The image processing consists of various steps to improve visualization of structures in the breast including, logarithmic conversion, skin line correction and contrast enhancement. These are standard methods used to allow optimal display and review of mammography images with minimal window/leveling operation.

The provided text describes a 510(k) submission for the Mammography Prior Enhancement (MPE) device and its substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria or a specific study that proves the device meets those criteria in a quantitative manner.

Here's a breakdown of the information available and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text in a quantitative or measurable format. The document focuses on demonstrating substantial equivalence based on intended use, technological characteristics, and safety/effectiveness concerns addressed by adherence to standards and risk management.
• Reported Device Performance: The text states, "The MPE software further processes and displays prior digital mammography images for physicians or trained medical personnel to use as a historical image reference when reviewing current Hologic digital mammography images. The MPE processed images will appear similar to Hologic digital images." This is a qualitative description of its function but lacks specific performance metrics (e.g., image quality scores, similarity metrics).

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

• Not provided. The document does not mention any specific test set size, data provenance (country of origin), or whether the data was retrospective or prospective.

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

• Not provided. There is no mention of experts, ground truth establishment, or their qualifications.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. Since no specific test set or ground truth establishment method is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

• Not performed or reported. The 510(k) summary does not describe any MRMC study comparing human reader performance with and without AI assistance. The focus is on image processing for comparison, not diagnostic performance improvement.

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

• Not performed or reported as a performance study. The device's function is standalone in the sense that it processes images automatically. However, there's no standalone performance study reported with specific metrics. Its output is explicitly stated as "for comparison purposes only and cannot be used for primary diagnosis," which inherently avoids standalone diagnostic performance claims.

7. The Type of Ground Truth Used:

• Not applicable/Not provided. As no performance study with a defined ground truth is described, this information is not present.

8. The Sample Size for the Training Set:

• Not provided. There is no mention of a training set or its size.

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

• Not applicable/Not provided. Since no training set or ground truth establishment is described, this information is not present.

Summary of available information related to "acceptance criteria" and "study":

The "study" or justification for the device's acceptance presented in this 510(k) is primarily based on:

• Demonstration of Substantial Equivalence: The MPE software shares the same intended use, technological characteristics, and performance standards as its predicate device (DigitalNow HD, K091368).
• Adherence to Standards: The device is designed and manufactured according to ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820.
• Risk Management: Potential hazards are controlled via risk management processes and verification and validation testing, ensuring "no risk of data loss" and that "MPE processed images are not intended for diagnosis."
• Intended Use Limitations: The key acceptance criterion implicitly stated is that the processed images are "for comparison purposes only and cannot be used for primary diagnosis."

The document focuses on regulatory compliance and safe operation within its limited intended use, rather than a quantitative clinical performance study with specific acceptance metrics. For a device intended "for comparison purposes only" and not for primary diagnosis, a full clinical performance study as might be expected for an AI diagnostic aid is often not required for 510(k) clearance, as the primary risk is misuse (i.e., using it for diagnosis), which is mitigated by labeling and intended use restrictions.

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