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The Xelis Fusion™ is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Diagnosis or computer aided diagnosis is not performed by the software but by Radiologists.

Images (including mammographic) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. In addition, Xelis Fusion™ can be integrated with an institutions HIS or RIS for an integrated an electronic patient record.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA.

XELIS Fusion is a Picture Archive and Communications System (PACS) software package intended for viewing and manipulating DICOM-compliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities. XELIS Fusion can be used for real-time viewing, 3D volume rendering, segmentation, registration, and reporting. XELIS Fusion application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems and is based upon the predicate device software used in Infinitt Xelis K082990. XELIS Fusion does not include any automated or semiautomated process for the detection of nodules or other shapes.

XELIS 3D Fusion is supplied to end users in both Windows 32 bit and 64 bit operating systems. The device software can connect to other workstations, PACS server/software, and modalities, through DICOM communication standard.

The provided 510(k) summary for XELIS Fusion does not contain a detailed study proving performance against specific acceptance criteria presented in a table format. Instead, it focuses on demonstrating substantial equivalence to predicate devices and describes general nonclinical testing.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list pre-defined acceptance criteria in a table or present specific performance metrics (like accuracy, sensitivity, specificity) for the XELIS Fusion device in relation to a specific study. It broadly states: "The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the XELIS Fusion software in each operational mode and followed the process documented in the System Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."

Therefore, a table cannot be constructed from the provided text.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The document only mentions "test at the factory" and "in-house testing criteria," implying internal testing, but no details on the origin of the data used for these tests. The testing seems to be focused on validating software functions rather than clinical performance on a specific dataset.
• Retrospective/Prospective: Not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The document describes functional testing of the software rather than a clinical performance study involving expert-established ground truth. The device is a PACS software for viewing and manipulating images, with diagnosis explicitly performed by radiologists, not the software.

4. Adjudication Method for the Test Set:

Not applicable, as no external test set with ground truth requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study is not mentioned or described. The device's indications for use explicitly state that "Diagnosis or computer aided diagnosis is not performed by the software but by Radiologists." This implies the device is a tool for radiologists, not an AI that improves their performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone performance study is not described. The device is a PACS software, and its primary function is display and manipulation, with diagnosis explicitly stated to be performed by human radiologists. It's not an AI algorithm designed to make diagnostic interpretations independently.

7. Type of Ground Truth Used:

Not applicable. The nonclinical testing described appears to be focused on software validation and verification against functional requirements, rather than clinical ground truth (like pathology or outcomes data) for diagnostic accuracy.

8. Sample Size for the Training Set:

Not applicable. The document describes the device as a Picture Archive and Communications System (PACS) software for viewing and manipulating images, not an AI/machine learning algorithm that requires a training set.

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

Not applicable, as there is no mention of a training set or an AI/machine learning component.

Summary of Device and Testing:

The XELIS Fusion device is described as a Picture Archive and Communications System (PACS) software package. Its primary functions involve viewing, manipulating, storing, and communicating DICOM-compliant medical images from various modalities (CT, PET, MRI, etc.). It explicitly states that "Diagnosis or computer aided diagnosis is not performed by the software but by Radiologists." The 510(k) submission focuses on demonstrating substantial equivalence to predicate PACS devices based on technical characteristics, general function, application, and intended use, and asserts that it does not introduce new safety risks.

The "Nonclinical Testing" section refers to in-house validation and verification activities to ensure the software's functionality and adherence to predefined acceptance criteria, which were related to evaluating "all input functions, output functions, and actions performed by the XELIS Fusion software in each operational mode." This is typical software development and quality assurance testing, not a clinical performance study with a test set of medical images and clinical ground truth.

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