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INFINITT Cardiology PACS™ 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 assists Cardiology surgeons when doing preoperative planning and post-operative follow-up.

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

INFINITT Cardiology PACS is a software device that consists of INFINITT Server (included Database), and INFINITT Cardiology PACS.

INFINITT Cardiology PACS is a web-based DICOM view station running on Windows 2000/XP. INFINITT Cardiology PACS fully supports the DICOM standard and such functions as advanced DICOM viewing, QCA and LVA. INFINITT Cardiology PACS allows users to take full advantage of the images from various modalities in order to obtain invaluable mission critical diagnostic data and images.

INFINITT supported modalities include: XA, Ultrasound/Echo, MRI, CT and CR/DR. In case of XA and Ultrasound, it offers numerous cardio-specific 2D analysis tools. Intuitive user interface and system architecture offer a configurable work list management and customizable display protocols.

Web based solution distributes images and relevant information to internal and external users at anytime. Remote diagnostic configuration enables fast information delivery in a low bandwidth network environment and centralized management module enables automatic update.

INFINITT Cardiology PACS supports interoperability between IHE approved workstations (Integrating the Healthcare Enterprise) with security functions.

This document is a 510(k) summary for the INFINITT Cardiology PACS™ and does not contain information regarding
acceptance criteria, device performance, or a study demonstrating that the device meets specific criteria. It primarily
focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

Therefore, I cannot provide the requested information based solely on the provided text. The document states that the device is a software device that does not provide any diagnostic assistance to the physician. This implies that performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic AI devices, would not be applicable or evaluated in the same manner for this type of system.

The closest relevant information is the indications for use, which outlines the intended functions of the device:

• Manipulation, displaying, and distribution of medical images.
• Display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
• Assists Cardiology surgeons when doing preoperative planning and post-operative follow-up.

For a device of this nature (a PACS for image management), acceptance criteria would typically revolve around:

• Functionality: Does it correctly display, store, and distribute images? Does it support the specified modalities and standards (DICOM)? Are the specified analysis tools (QCA, LVA) present and operational?
• Performance (technical): Speed of image retrieval, display quality, system stability, data integrity, security, and interoperability.
• Usability: User interface effectiveness for trained professionals.

Without a specific study described in the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

The document concludes by stating that the 510(k) "contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." This typically means that the device was shown to be as safe and effective as existing legally marketed devices for its stated intended use, based on its technological characteristics and performance specifications (which are not detailed here in quantifiable terms).

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