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Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.

The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.

The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis. but it does not directly generate any diagnosis or potential findings.

The following visualization, quantification and data-reporting functionalities are provided by the software:

Visualization:

• 2D image review -
• 3D image review by means of MIP, MinIP, Surface or Average -
• Multi-planar reconstruction (MPR) views (axial, coronal, sagittal, and oblique) -
• Image navigation tools -
• Cine play -

Quantification:

• Distance and area measurements -
  Data reporting:
  The distance, area, and user-selected annotated images are displayed to the user within the software client web browser. The user has the option to save the data for later use. The user can also send the data to PACS, for review.

This document describes the Arterys Viewer, a medical imaging software. However, the provided text does not contain acceptance criteria, a study proving the device meets those criteria, or specific performance data related to accuracy or clinical effectiveness.

The document focuses on:

• General Information: Manufacturer, contact, date prepared.
• Device Description: Intended use (DICOM and non-DICOM data management, display, processing, storage, transfer), functionalities (visualization, quantification, data reporting).
• Indications for Use: What the device is intended for and who uses it (trained medical professionals).
• Comparison to Predicate and Reference Devices: A detailed table comparing feature sets, highlighting similarities and minor differences, and concluding substantial equivalence to a predicate PACS system and a previous version of their own software. This comparison is primarily about feature parity and technological characteristics, not clinical performance.
• Performance Data (General Statement): A general statement that safety and performance have been evaluated and verified according to software specifications, applicable performance standards, and relevant FDA/IEC guidance documents.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document asserts that the device is substantially equivalent to a predicate, meaning it performs similarly and raises no new questions of safety or effectiveness, but it does not present a specific study with acceptance criteria and a detailed demonstration of the device meeting those criteria.

Here's a summary of what can be extracted from the provided text regarding performance context:

• Device Name: Arterys Viewer
• Regulation Number: 21 CFR 892.2050
• Regulation Name: Picture archiving and communications system
• Product Code: LLZ
• Regulatory Class: II

Regarding the specific questions:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for clinical use. The "acceptance" is implied through substantial equivalence to a predicate device, meaning it performs its intended functions similarly and safely.
   • Reported Device Performance: No specific numerical performance data (e.g., accuracy, sensitivity, specificity, or measurement agreement) is provided. The performance is described in terms of its functionalities (display, processing, storage, measurements) and claimed to be verified through software V&V.

2. Sample size used for the test set and the data provenance: Not provided. The document mentions "software verification and validation testing" but does not detail the size or nature of the test data (e.g., retrospective/prospective, country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.

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: Not provided. The device is a "Viewer" and "does not directly generate any diagnosis or potential findings," implying it's a tool for professionals rather than an AI-assisted diagnostic algorithm in the sense of directly improving reader performance on a diagnostic task specified here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not provided. The device is intended to be used by "trained medical professionals" who interpret the information, so a purely standalone performance claim would be contrary to its stated use.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided.

8. The sample size for the training set: Not applicable based on the available information. The device is described as a "Viewer" with visualization and measurement tools, rather than a machine learning model that requires a distinct "training set" in the common understanding of AI/ML devices.

9. How the ground truth for the training set was established: Not applicable, as no training set is described.

In conclusion, the document primarily makes a case for substantial equivalence based on functional and technological characteristics compared to predicate devices, supported by general software verification and validation activities, rather than presenting a detailed clinical performance study with acceptance criteria.

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