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Agfa's IMPAX Next Generation is a Picture Archiving and Communications System (PACS). It provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. IMPAX Next Generation is intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data.

MPR, MIP and 3D rendering functionality allows the user to view image data from perspectives different from that in which it was acquired. Other digital image processing functionality such as multi-scale window leveling and image registration can be used to enhance image viewing.

As a comprehensive imaging suite, IMPAX Next Generation integrates with servers, archives, Radiology Information Systems (RIS), Hospital Information Systems (HIS), reporting and 3rd party applications for customer specific workflows.

Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for mammographic use.

The new device is largely similar to the predicate devices. It is a comprehensive PACS system that combines the features of IMPAX system with the mammography workstation. This new version includes improvements to the user interface and is designed for ease of deployment and service. It also includes an integrated patient information system, report generation and transcription features.

Principles of operation and technological characteristics of the new and predicate devices are the same. There is no change to the intended use of the device vs. the predicate devices.

Agfa's IMPAX Next Generation is a PACS device for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic and treatment planning purposes.

It is a software device running on commercially available computer equipment that allows users to view and modify DICOM compliant medical images and patient information.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IMPAX Next Generation device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for IMPAX Next Generation does not explicitly state quantitative acceptance criteria or a specific performance study with measured results against those criteria in a typical format (e.g., sensitivity, specificity, accuracy thresholds). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through functional comparison and adherence to relevant standards.

The "performance" described is largely functional and adherence to standards:

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

The submission explicitly states: "No clinical trials were performed in the development of the device."

Therefore, there is no test set sample size and no data provenance as traditionally understood for performance evaluation against a dataset. The testing was limited to validation that usability, measurements, image processing, and image quality meet user expectations, and conformance to documented requirements and standards.

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

As no clinical trials or performance studies on a distinct test set were conducted, there were no experts used to establish ground truth for a test set. The evaluation was primarily based on internal validation and conformance to standards.

4. Adjudication Method for the Test Set

Since no clinical trials or test set performance evaluation were conducted, there was no adjudication method applied.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "No clinical trials were performed in the development of the device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The device is a Picture Archiving and Communications System (PACS), which is a software system for image management, display, and processing, intended to be used by healthcare professionals, not an AI algorithm that produces a diagnostic output on its own. Therefore, the concept of "standalone (algorithm only)" performance as typically applied to diagnostic AI algorithms does not apply to this device in the context of this 510(k). Its "performance" is its functional capability and adherence to standards for displaying and manipulating medical images for human interpretation.

7. The Type of Ground Truth Used

Given that no clinical trials or performance studies were conducted, there was no ground truth established in the sense of a medical truth (e.g., pathology, outcomes data, expert consensus on disease presence). The "ground truth" for the validation of this PACS system was its adherence to functional requirements and industry standards.

8. The Sample Size for the Training Set

Since this is a PACS system and not an AI/ML diagnostic algorithm, there is no training set in the traditional sense. The device's capabilities are based on established software development and display methodologies, not on learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this device, there is no ground truth established for a training set.

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