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Infinitt G3 PACS is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.

INFINITT G3 PACS is a web-based 3D-enabled DICOM viewing station running on Windows 2000/XP. It is adapted for, storing, processing routing and report generating. INFINITT G3 PACS fully supports the DICOM standard and such functions as advanced DICOM viewing, Hanging Protocol, 3D segmentation, various MPRs, fast 3D Volume Rendering, MIP, and Virtual Endoscopy.

INFINITT G3 PACS allows users to take full advantage of the radiographic images from various modalities in order to obtain invaluable mission critical diagnostic data and images. With INFINITT G3 PACS, users can have the same diagnostic environment of their own anywhere anytime because INFINITT G3 PACS is deployed through network and supports hanging protocol radically.

This 510(k) submission for the Infinitt G3 PACS does not contain the information requested regarding acceptance criteria and a study demonstrating the device meets those criteria.

The provided document is a 510(k) Summary of Safety and Effectiveness, which primarily focuses on establishing substantial equivalence to a predicate device. It describes the device's functions and indications for use but does not include:

• A table of acceptance criteria and reported device performance.
• Details of a study conducted to demonstrate performance. This would typically involve specific metrics (sensitivity, specificity, accuracy, etc.) and the results achieved.
• Sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance data, type of ground truth, training set size, or how training ground truth was established. These are all elements of a robust performance study that are absent in this summary.

Key observations explaining the absence of this information:

• Nature of the Device: The Infinitt G3 PACS is described as a "Picture Archiving Communications System" (PACS). Its primary function is to store, display, communicate, and process medical images, not to perform automated diagnostic interpretation or provide quantitative measurements that would necessitate extensive clinical performance metrics like those for an AI diagnostic algorithm.
• Predicate Device Equivalence: The submission focuses on demonstrating "substantial equivalence" to a predicate PACS device (INTEGRADWEB MPR/MIP, K042313). For PACS systems, substantial equivalence often relies on demonstrating similar technological characteristics, functionality, and safety profiles, rather than extensive clinical performance studies comparing diagnostic accuracy.
• Human-in-the-Loop: The document explicitly states: "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." This highlights that the device is an aid to human interpretation, not a standalone diagnostic tool.
• Specific Limitations on Mammography: The document includes specific limitations for mammography: "Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA." These are usage constraints for a specific diagnostic application, not performance metrics.

In summary, the Infinitt G3 PACS, as described in this 510(k) summary, is a medical imaging display and management system. Its regulatory pathway for approval did not require the kind of detailed performance study and acceptance criteria typically associated with AI-powered diagnostic or screening devices.

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