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Encompass™ is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. Encompass™ is software comprised of modular software programs that run on standard "off-the-shel?' personal coonyters and servers running the Windows 2000/XP operating system. Encompass™ is image data surage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging transfer. The system provides the capability to; consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative measurements on both cath and ultrasound images, perform quantitative analysis on cath images, generate and on voview patient reports with additional measurement and report writer capabilities and provides accessible digital image archive. Encompass™ is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).

Encompass™ is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. Encompass™ is software comprised of modular software programs that run on standard "off-the-shelf" personal computers and servers running the Windows 2000/XP operating system. Encompass™ is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging transfer. The system provides the capability to; consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative measurements on both cath and ultrasound images, perform quantitative analysis on cath images, generate and review patient reports with additional measurement and report writer capabilities and provides accessible digital image archive. Encompass™ is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users). The original core functionality is detailed below:

1. Review of x-ray angiography, ultrasound, intravascular ultrasound, computed tomography (CT), nuclear medicine, and magnetic resonance imaging (MRI) images.
2. Compare images from different studies on one or two monitors, regardless of modality.
3. Perform report data entry and view the report.
4. Print, save as mpeg/avi, save as bitmap, and copy to clipboard any image(s).
5. Perform standard image processing such as brightness, contrast, gamma, sharpen, window/level, invert, pan, zoom, and digital subtraction.
6. Perform standard stop, start, single frame advance and reverse, previous/next image playback, and various standard clinical presentations.
7. Control the speed of playback.
8. Use a supported jog wheel to control playback.
9. Play/repeat a subset of a loop with user defined begin and endpoints.
10. Search sources for studies based on demographic information.
11. Copy any study or subset of study from any supported source to any supported destination.
12. Write DICOM study to CD/DVD for interchange.
13. Calibrate the monitor to a SMPTE pattern.

The provided text does not contain detailed information about acceptance criteria and a specific study proving that the device meets these criteria in the format requested. The document is a 510(k) summary for the Encompass™ Cardiac Network Image Processing System, which describes the device, its intended use, and substantial equivalence to predicate devices, along with design control activities.

However, based on the Summary of Design Control Activities section, the document states:

"All verification and validation activities were performed by the designated individual(s), and the results demonstrated that the predetermined acceptance criteria were met."

This indicates that some form of testing was done to verify the device met pre-defined criteria, but the specifics of these criteria, the study design, and the reported performance are not detailed for most of the requested points.

Here's a breakdown of what can be inferred or directly stated from the text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

The document broadly mentions "predetermined acceptance criteria were met" but does not provide a table specifying what these criteria were or the quantitative performance metrics achieved by the device. The listed standards (DICOM, 21 CFR 1020.10, SMPTE, etc.) imply compliance, but actual performance against these is not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text mentions "Integration testing (System verification)" and "Final acceptance testing (Validation)" but does not specify the dataset used for these tests, its size, or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The device is for "diagnostic quality image review" and "aid in diagnosis," implying expert involvement, but details on how ground truth was established for testing are absent.

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

This information is not provided in the document.

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

This information is not provided in the document. The device offers "analysis and measurement capabilities" and "graphical representation," but there's no mention of a comparative effectiveness study with human readers or AI assistance effect sizes.

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

The document describes the device as "image data storage and display software" with capabilities for "quantitative measurements" and "quantitative analysis." While it performs these functions, it's considered a system for medical professionals to use. The text does not explicitly detail a standalone algorithm-only performance study without human-in-the-loop interaction. Its design implies it's an assistive tool.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. The document primarily focuses on a modification to existing software and its compliance with standards and design control. It does not describe a machine learning model's training process.

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

This information is not provided in the document.

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