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ICIS® View is a software application used for reference viewing of medical images and associated reports and, as such, fulfills a key role in Agfa HealthCare's Imaging Clinical Information System (ICIS). ICIS® View enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images and data from multiple departments and organizations within one multi-disciplinary viewer.

Users may access the product directly via a web-browser, select mobile devices, healthcare portal or within the Electronic Medical Record (EMR). ICIS® View allows users to perform basic image manipulations and measurements (for example window/level, rotation, zoom, and markups).

ICIS® View can optionally be configured for Full Fidelity mode, which is intended for diagnostic use, review and analysis of CR, DX, CT, MR, US images and medical reports. ICIS® View Full Fidelity is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. ICIS® View full fidelity is not intended for the display of digital mammography images for diagnosis.

Agfa's ICIS® View system is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks.

The new device is substantially equivalent to the predicate devices (K103785, K022292, & K111164). It is a multidisciplinary viewer that allows the user to securely access patient images and reports from any PACS or vendor-neutral archive. Images and reports can be viewed directly via a web-browser, select mobile device, healthcare portal or Electronic Medical Record (EMR). The new device includes some of the clinical tools of the predicate devices specifically the functionality to retrieve original lossless renditions of stored images for diagnostic purposes.

The optional Full Fidelity functionality allows the retrieval of original lossless renditions of stored CR, DX, CT, MR, and US images for diagnostic purposes on select mobile devices or FDA cleared display monitors when there is no access to a full workstation.

The provided text describes the 510(k) submission for AGFA Healthcare's ICIS® View device. This device is a Picture Archiving and Communications System (PACS) software intended for reference viewing of medical images and associated reports. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria table" with specific quantitative metrics (e.g., sensitivity, specificity, or numerical performance thresholds for image quality). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices, primarily through qualitative evaluations of image quality and functional parity.

The core acceptance criterion is that the ICIS® View system performs equivalently to the predicate devices in terms of diagnostic image quality when used in "Full Fidelity" mode.

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

• Sample Size: A "sample set of an average of 6 imaging studies per modality (CR, DX, CT, MR, US)" was evaluated. This means approximately 30 studies in total (6 studies * 5 modalities).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "laboratory data" and "image quality evaluations conducted with qualified radiologists," suggesting existing image datasets were used for testing, which typically points to retrospective data.

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

• Number of Experts: The document states "qualified radiologists" were used. The exact number of radiologists is not specified.
• Qualifications of Experts: The experts are described as "qualified radiologists," indicating they are medical professionals specializing in radiology. No specific experience levels (e.g., "10 years of experience") are provided in the text.

4. Adjudication Method for the Test Set

The document states that qualified radiologists "were asked to provide an acceptable or unacceptable score when comparing the diagnostic quality...to the IMPAX predicate." This suggests a comparative evaluation rather than a direct adjudication for "ground truth" of disease presence. The adjudication here seems to be on the equivalence of display quality for diagnostic interpretation rather than agreement on specific findings. No specific multi-reader adjudication method (e.g., 2+1, 3+1) is described for establishing a definitive "ground truth" diagnosis for each case within the test set itself, as the assessment was comparative to a predicate display rather than a diagnostic accuracy study measuring against a reference standard.

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

• The study described is a comparative evaluation between the new device and a predicate device by "qualified radiologists." While radiologists evaluated multiple cases, the study's primary goal was to establish display equivalence for diagnostic purposes, rather than a formal MRMC study aimed at quantifying the effect size of AI assistance on human reader performance.
• Effect Size of AI vs. Without AI Assistance: This study did not involve AI assistance. The ICIS® View device is a PACS viewer, not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding AI assistance was not applicable and not conducted. The comparison was between two different display systems (ICIS® View vs. IMPAX Workstation).

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

• As ICIS® View is a PACS viewer software, not a diagnostic algorithm, the concept of "standalone performance" in the context of an algorithm's diagnostic accuracy is not directly applicable.
• The performance evaluation focused on the visual equivalence of the images displayed by the device compared to a predicate, as interpreted by human radiologists. It is a human-in-the-loop assessment of the display quality.

7. The Type of Ground Truth Used

• The "ground truth" in this context is not a pathological diagnosis or clinical outcome, but rather the "diagnostic quality" provided by the predicate system (Agfa's IMPAX 6.6.1 workstation). Radiologists were asked to assess whether the ICIS® View's display quality was "acceptable" when compared to the established diagnostic quality of the predicate. This is a form of expert consensus/comparison against an established standard (the predicate's display) for the purpose of demonstrating substantial equivalence of image rendering.

8. The Sample Size for the Training Set

The document does not mention a "training set" for the ICIS® View device, as it is a PACS viewing software, not a machine learning or AI model that requires a data-driven training phase. The development and testing focused on software functionality and image display fidelity.

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

Since there is no mention of a training set or an AI/ML component, this question is not applicable based on the provided text.

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