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Xelis Cardiac™ is intended for the manipulation, displaying, and distribution of medical images. It can display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device is used by physicians when doing preoperative planning and post-operative follow-up. Device functions are initiated manually by the user and are not performed automatically or semi-automatically by the software. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not by the software.

Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists).

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Xelis Cardiac™ is a software device intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities.

Xelis Cardiac™ is a software device that consists of INFINITT Server (Database), and the software application which supports the DICOM standard with such functions as advanced DICOM viewing.

The subject device allows users to take advantage of the images from various modalities in order to view data and images and the web based solution distributes images and relevant information to internal and external users at anytime. Remote diagnostic software configuration enables fast information delivery in a low bandwidth network environment and centralized management module enables automatic update.

Xelis Cardiac™ supports interoperability between IHE approved workstations (Integrating the Healthcare Enterprise) with security functions.

Xelis Cardiac™ does not perform computer aided diagnosis and does not include anv automated or semi-automated processes for the detection of nodules or other diseases and is not intended for use with or for the primary diagnostic interpretation of Mammography images.

The software does not provide diagnostic assistance to the physician. Any diagnostic determination or treatment is solely made by a physician and not the software.

The provided document describes XELIS Cardiac™, a software device for viewing and manipulating medical images. Based on the content, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "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." And "If the device is installed by INFINITT CO., LTD, integration and installations verification tests are conducted against acceptance criteria prior to release to the client."

However, the specific "predetermined acceptance criteria" themselves (e.g., performance metrics, thresholds) are not detailed in the provided text. The document broadly states that the device "passed all in-house testing criteria" and "demonstrated that the predetermined acceptance criteria were met."

Therefore, a table of specific acceptance criteria and reported performance cannot be provided from this text. The study primarily focuses on demonstrating functional equivalence and safety (non-inferiority) to predicate devices rather than specific quantitative performance metrics.

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

The document does not explicitly state the sample size used for any specific test set related to image data or patient cases. It mentions "The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria."

The data provenance (e.g., country of origin, retrospective or prospective) for any image data used in testing is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document states that the software "does not provide diagnostic assistance to the physician. Any diagnostic determination or treatment is solely made by a physician and not the software." It also mentions "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."

However, there is no information provided regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set (e.g., for diagnostic accuracy or image interpretation performance). The study appears to be primarily focused on the functional performance and reliability of the software as an image viewing and manipulation tool, rather than its diagnostic accuracy comparative to human experts.

4. Adjudication Method for the Test Set

Since no specific test set involving human interpretation or ground truth establishment based on expert consensus is described, there is no information provided on any adjudication method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in the provided text. The document explicitly states that the software "does not perform computer aided diagnosis and does not include any automated or semi-automated processes for the detection of nodules or other diseases" and "does not provide any diagnostic assistance to the physician." Therefore, a study comparing human readers with and without AI assistance is not relevant to this device's intended use.

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

A standalone performance study of the algorithm without human-in-the-loop performance, in the context of diagnostic performance, was not conducted or reported. The device's primary function is as a PACS system for image viewing and manipulation, where the "human-in-the-loop" (the physician) is always the ultimate interpreter. The non-clinical testing focused on system functional performance and validation.

7. Type of Ground Truth Used

The document does not describe the use of any ground truth (e.g., expert consensus, pathology, outcomes data) in the context of evaluating diagnostic accuracy or similar performance metrics. The testing focused on validating the software's functional capabilities (input, output, actions) against internal criteria.

8. Sample Size for the Training Set

Since the device "does not perform computer aided diagnosis" and does not employ AI/ML algorithms that would typically require a training set for diagnostic tasks, there is no information provided regarding a training set sample size.

9. How Ground Truth for the Training Set Was Established

As no training set is described for diagnostic AI/ML algorithms, there is no information provided on how ground truth would have been established for such a set.

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Xelis 3D™ is a software device intended for viewing of images acquired from various imaging modalities: CT. MR. CR. DR. US. PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.

XELIS 3D is a software package intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities. XELIS 3D can be used for real-time viewing, 3D volume rendering, segmentation, registration, and reporting.

XELIS 3D 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 3D does not include any automated or semi-automated process for the detection of nodules or other shapes.

XELIS 3D 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 text describes the XELIS 3D software, a picture archiving and communications system, and its substantial equivalence to predicate devices. However, it does not contain specific details regarding acceptance criteria and a structured study with quantifiable performance metrics. Instead, it focuses on demonstrating that XELIS 3D performs as intended and is as safe and effective as its predicate devices.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance Study for XELIS 3D

The XELIS 3D is a software package intended for viewing and manipulating DICOM-compliant medical images. The submission for its 510(k) clearance emphasizes its substantial equivalence to predicate devices rather than presenting a comparative effectiveness study with specific quantified acceptance criteria and performance metrics against a defined ground truth.

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific, quantifiable acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or any task-specific performance measures. Instead, the acceptance criteria are described in more general terms related to system functionality and safety.

2. Sample Size and Data Provenance (Test Set)

The document does not provide specific details on the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of the data. The testing described is "in-house testing criteria" and "validation testing" which seem to refer to internal software quality assurance rather than a clinical performance study with a distinct test set of patient cases.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

This information is not provided in the document. The text indicates that "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians," implying that human experts are responsible for interpretation, but it does not specify how ground truth was established for any performance evaluation in the context of the device's 510(k) submission.

4. Adjudication Method (Test Set)

An adjudication method (e.g., 2+1, 3+1) for establishing ground truth on a test set is not mentioned in the provided text, as a specific clinical test set for performance evaluation is not detailed.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information regarding the effect size of how much human readers might improve with or without AI assistance, as the device primarily functions as a viewing and processing tool, not an AI-assisted diagnostic aid for detection. The text explicitly states: "XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes."

6. Standalone Performance Study (Algorithm Only)

A standalone performance study of the algorithm without human-in-the-loop performance is not described. Given the device's function as an imaging workstation and its statement that "Diagnosis is not performed by the software," a standalone study for diagnostic performance would not be applicable or expected. The testing described focuses on functional verification of the software.

7. Type of Ground Truth Used

The type of ground truth used (e.g., expert consensus, pathology, outcomes data) for any performance evaluation is not specified. The regulatory submission focuses on demonstrating functional equivalence and safety rather than a diagnostic performance study against a clinical ground truth.

8. Sample Size for the Training Set

The document does not provide information on a training set size. As the XELIS 3D does not perform automated detection or analysis (i.e., it doesn't describe AI/ML functionality requiring a training set), this information would not be relevant in this particular submission.

9. How Ground Truth for Training Set Was Established

Similarly, since there's no mention of a training set for an AI/ML algorithm, the method for establishing ground truth for a training set is not discussed.

In summary, the 510(k) submission for XELIS 3D demonstrates substantial equivalence primarily through functional verification, safety assessments, and conformance to standards (like DICOM 3.0), rather than through a clinical performance study with defined quantifiable acceptance criteria against a clinical ground truth. The device is presented as an image viewing and manipulation tool, not an automated diagnostic system, hence many of the requested elements pertaining to AI/ML performance studies are not present or applicable in this context.

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