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• MR Permeability facilitates the radiologist in visualizing and post-processing dynamic contrast-enhanced datasets. It is an optional package within IntelliSpace Portal.
• MR Permeability can be used by the radiologist to assess the micro-vascular properties by computing vascular permeability (Ktrans), tracer efflux rate (Kep), extravascular volume fraction (Ve), plasma fraction (Vp), and Area under the curve (AUC) from T1 images of brain and prostate. The applied pharmacokinetic modeling is based on the Tofts model:
• The results are presented back to the user in the form of a parametric map, a table of results and in a graph.
• MR Permeability facilitates the visualization of areas with increased permeability.
• MR Permeability facilitates the visualization of variations in permeability.
• MR Permeability is a software tool for visualizing and post processing dynamic contrast- enhanced 3D datasets, acquired to visualize areas with abnormal vascularity.

IntelliSpace Portal is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal is a medical software system that allows multiple users to remotely access IntelliSpace Portal from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

The MR Permeability integrated into the IntelliSpace portal is used for processing MR T1 images to generate parametric maps, which help in studying micro-vascular properties. It is a client-server based application developed using Philips Informatics Infrastructure (PII) platform and is integrated into IntelliSpace portal. Communication and data exchange between client-server and with other portal components use standards like TCP/IP and DICOM.

Here's an analysis of the acceptance criteria and study information for the Philips MR Permeability device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K130278) is a 510(k) premarket notification for the Philips MR Permeability device. Unlike a Pre-Market Approval (PMA) application, a 510(k) typically doesn't present a detailed study with specific quantitative acceptance criteria for clinical performance metrics (like sensitivity, specificity, accuracy) against a defined ground truth. Instead, the primary goal of a 510(k) is to demonstrate substantial equivalence to a previously legally marketed predicate device.

The "acceptance criteria" in this context are implicitly the features and functionalities of the predicate device, nordicICE Software, and the study's goal is to show that the new device performs as well as or better than this predicate.

Acceptance Criteria (Implied by Predicate Comparison) and Reported Device Performance:

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

The document states: "The conclusion from testing the device against synthetic data as well clinical data is: 'Based on the test results, the MR Permeability analysis functions according to its intended use'."

• Sample Size (Test Set): Not explicitly stated. The document mentions "clinical data" but does not quantify the number of cases or patients used for this testing.
• Data Provenance: Not specified. It mentions "synthetic data" and "clinical data". The origin (e.g., country of origin, specific institutions) and whether the clinical data was retrospective or prospective are not provided.

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

This information is not provided in the summary. For a 510(k) focused on substantial equivalence to software, detailed expert review for ground truth establishment might not be a primary focus as it would be for novel diagnostic algorithms. The testing described appears to be more technical verification ("functions according to its intended use") rather than a clinical performance study against an expert-derived ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the evaluation described (technical verification and comparison to synthetic data/unspecified clinical data), a formal adjudication method for a test set ground truth is unlikely to have been documented in this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to the predicate device in terms of functionality and safety, not on measuring human reader improvement with or without AI assistance.

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

The document mentions "The MR Permeability verification tests were performed on the complete system relative to the verification, regression and test specifications" and "testing the device against synthetic data as well clinical data." This indicates that the algorithm's performance in generating parametric maps was tested. Since the device's output (parametric maps, tables, graphs) is consumed by a radiologist, and the testing description speaks to its functionality, it implicitly covers the standalone performance of the algorithm in generating these outputs.
Yes, tests were performed on the device's ability to generate the specified parametric maps and analysis results.

7. The Type of Ground Truth Used

The ground truth implicitly used for the verification was:

• Synthetic data: Likely mathematically derived "ideal" or known pharmacokinetic profiles to test the accuracy of the Tofts model calculations and parametric map generation.
• Unspecified "clinical data": The nature of the ground truth for this clinical data is not specified (e.g., whether it was pathology, follow-up outcomes, or consensus readings). Given the context of a 510(k) for a post-processing tool, it's more likely that the clinical data was used to verify consistency and expected output generation rather than providing an independent 'gold standard' for disease presence/absence.

8. The Sample Size for the Training Set

This information is not provided. The 510(k) summary does not detail the development or training of the algorithm, as it's primarily concerned with demonstrating equivalence post-development.

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

This information is not provided. As with the training set size, the summary does not delve into the development methodology or ground truth establishment for algorithm training.

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