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The AquariusNET Server acquires, stores, transmits, and enables compatible computers on a network to display medical images from medical scanning devices and patient reports of various types. Teleradiology, such as MRI, CT or NM and archiving, image manipulation, 3D and 4D visualization are supported. Calcium scoring from whole body computed tomography derived measurements, for non-invasive detection and quantification of atherosclerotic plaque. Tools for histogram analysis of the density distribution of certain regions of interest are provided. A database management and report generation tool is included.

AquariusNET is a device consisting of a DICOM server that receives and stores images from a PACS or other image giving modalities. It archives images in a scalable storage medium and delivers them in response to DICOM Query/Retrieve requests from other DICOM devices on the network (not part of AquariusNET). It also serves image requests to its remote "thin clients", which act as the graphical user interface to the AquariusNET server. The server can host multiple concurrent sessions from remote "thin clients". AquariusNET features an integrated 2D/3D streaming engine which allows regular PCs or notebooks to control the server, and to review 2D images and 3D reconstructions interactively over a network. AquariusNET is capable of image review, communications, archiving, database maintenance, reporting and basic 3D capabilities described elsewhere in this document. It is also capable of full-color Volume Rendering and Calcium Scoring.

The provided text is a 510(k) Premarket Notification Summary for the AquariusNET Server. It describes the device, its features, and its intended use, focusing on its substantial equivalence to predicate devices. However, the document does not contain the following information typically found in a study proving a device meets acceptance criteria:

1. A table of acceptance criteria and the reported device performance: The document includes a "Feature Comparison Table" that lists features present in the AquariusNET Server and its predicate devices. This table serves to demonstrate functional equivalence, not performance against specific, quantitative acceptance criteria.
2. Sample size used for the test set and the data provenance: No information about a test set, its size, or data origin is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of experts or ground truth establishment for a test set.
4. Adjudication method for the test set: Not applicable as no test set evaluation is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is an image communication and storage system with advanced visualization; its performance is described in terms of features rather than an algorithmic standalone performance study.
7. The type of ground truth used: Not applicable as no ground truth is mentioned for performance evaluation.
8. The sample size for the training set: No training set is mentioned as this is not a machine learning algorithm claim in the modern sense.
9. How the ground truth for the training set was established: Not applicable.

Summary of the document's content relevant to acceptance criteria and study:

The document demonstrates substantial equivalence to predicate devices (Imatron Ultra Access Workstation with Cardiac Software Extensions (K972903) and TeraRecon IiVS™ Integrated Image Viewing Station (K994329)) by comparing features.

Acceptance Criteria (Implied by Substantial Equivalence):

The implied acceptance criteria are that the AquariusNET Server possesses equivalent features and performance to the predicate devices for its intended use. The "Feature Comparison Table" acts as the primary evidence for meeting these implied criteria.

Study Proving Acceptance Criteria (as presented in the 510(k) Summary):

The "study" is a feature comparison study against two predicate devices. The document implies that by demonstrating the presence of these features, the device is "substantially equivalent" to legally marketed devices, thereby meeting the regulatory requirements for market clearance.

• Sample Size for Test Set & Data Provenance: Not applicable. The submission relies on a feature-by-feature comparison rather than performance testing on a specific dataset.
• Number of Experts & Qualifications for Ground Truth: Not applicable. No ground truth for a test set is established.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not performed or reported.
• Standalone Performance Study: The document focuses on the functional capabilities of the system rather than an isolated algorithmic performance evaluation.
• Type of Ground Truth: Not applicable.
• Sample Size for Training Set: Not applicable, as this is not an AI/ML model in the modern sense.
• Ground Truth for Training Set: Not applicable.

In essence, the "study" demonstrating acceptance is the comparison table itself, showing that the AquariusNET Server either matches or exceeds the features of its predicate devices, especially regarding calcium scoring functionalities compared to the IiVS, and matches the Imatron Ultra Access Workstation. The FDA's issuance of the 510(k) clearance acts as the formal acceptance that the device is substantially equivalent based on this comparison.

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