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The Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.

Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis.

The AW 4.1 is positioned to be the system of choice for all users of CT, MR. Vascular Xray, Cardiac Xray, Digital Xray, PET or even PET/CT systems, MG, NM, US, SR.

The provided text is a 510(k) summary for the GE Advantage Workstation 4.1. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove their fulfillment is not explicitly present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that the Advantage Workstation 4.1 "provides images comparable to the predicate device." However, it does not provide a table of quantitative acceptance criteria or reported performance metrics against those criteria. The primary "acceptance" criteria for this 510(k) appears to be substantial equivalence to the predicate device, K960613 (Advantage Windows Review Workstation).

Table of Acceptance Criteria and Reported Device Performance:

Study Details

The document does not describe a specific clinical or technical study designed to prove the device meets quantitative performance acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a previously cleared device.

1. Sample size used for the test set and the data provenance: Not applicable. The document does not describe a test set or study involving patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
3. Adjudication method for the test set: Not applicable.
4. 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 applicable. This document predates widespread AI in medical imaging interpretation and does not describe such a study. The device is a workstation for image review, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a workstation for human review, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable. The device is not an AI model that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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The GF: Advantage Windows Review Workstation is a two dimensional review station which allows selection and review of DICOM images from Computed Tomography (CT), Magnetic Resonance (MR), X-Ray (XR), Computed Radiography (CR) and Secondary Capture (SC) modalities.

The GE Advantage Windows Review Workstation consists of a Sun Microsystems Spare 4, 5, 20 or UltraSparc Unix workstation or equivalent with 32 to 128 MBytes of RAM, 1 to 4 GBytes of mass storage memory, an Ethernet or ATM networking interface and 1 to 4 color landscape or high resolution monochrome monitors. The GE Advantage Review Windows software application is designed and produced by GE Medical Systems. Earlier versions of this software were included in previous 510(k) Premarket Notification submissions (K913770, K942120).

This document is a 510(k) summary for a GE Medical Systems device modification (K960613). It focuses on the GE Advantage Windows Review Workstation. Based on the provided text, the document describes a device modification and primarily discusses its substantial equivalence to previously cleared devices.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the detailed study specifics requested in your prompt.

The "Summary of Studies" section only states: "In addition to system design verification tests to assure conformance with the design specifications, the design has or will undergo further validation to assure overall user satisfaction." This indicates that design verification tests were done to meet specifications and that further validation for user satisfaction was planned or ongoing. It does not provide any detailed results or acceptance criteria relating to clinical performance.

Therefore, I cannot populate the requested sections based on the provided text. The document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed technical or clinical study report.

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