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MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data.

MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.

Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, yield information that may assist in biliary system assessment.

MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired on supported MR scanners using supported MRCP acquisition protocols.

MRCP+v1 is suitable for all patients not contra-indicated for MRI.

MRCP+v1 is a standalone software device. The purpose of the MRCP+v1 device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator, typically a radiographer or technician trained in radiological anatomy, loads as input into the MRCP+v1 device previously acquired MRCP data. The device is intended to be used by a trained operator to generate metrics in the form of a summary report to enable reporting by a radiologist for subsequent interpretation and diagnosis by a clinician.

MRCP+v1 is designed to utilize DICOM 3.0 compliant MRCP datasets, acquired on supported MR scanners, to display the fluid-filled tubular structures in the abdomen, including the intra- and extrahepatic biliary tree, gallbladder and pancreatic ductal system.

Analysis and evaluation tools include:

• Segmentation of structures utilising user input of seeding points.
• Interactive labelling of segmented areas.
• Quantitative measurement derived from segmentation and labelling results.

MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.

The radiologist may use existing radiological tools to report on the biliary tree. The reviewing radiologist needs to take into consideration the device's limitations and accuracy during review. The MRCP+v1 report is intended to supplement a conventional radiology report, for interpretation by a clinician.

MRCP+v1 does not replace the usual procedures for assessment of the biliary system by a reviewing radiologist or interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed.

The metrics are intended to be used as an additional input to radiologists and clinicians in addition to that provided by conventional MRCP.

The provided FDA 510(k) document for MRCP+ v1.0 describes its acceptance criteria and the studies performed to demonstrate its performance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance thresholds that must be met. Instead, it reports the observed performance metrics and concludes that the device is "highly accurate," "highly repeatable," and "reproducible," and that "the variation introduced by operator analysis is well within the prescribed acceptance criteria set for performance testing."

However, we can infer the acceptance criteria are related to the reported 95% Confidence Intervals (CI) for the Limits of Agreement, with the implicit goal being that these limits should be acceptably narrow.

Here's a table summarizing the reported device performance:

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

• Algorithmic Accuracy (Digital Synthetic Data): "a dataset of digital synthetic data" - no specific number of samples is provided.
• Device Accuracy (Physical Phantoms): "Two different types of phantom, a clinical and tubewidth" - no specific number of scans or repetitions is provided. One would infer 'multiple' scans given the reporting of CI, but the exact count isn't in the provided text.
• Precision (In-vivo Data): "in-vivo data acquired from volunteers" - no specific number of volunteers or scans is provided.
• Intra- and Inter-Operator: No specific sample size (number of cases or readings) is provided.

Data Provenance: The provenance is described as:

• "digital synthetic data"
• "phantom scans"
• "in-vivo (healthy volunteer and patients with suspected hepatobiliary disease) scans"
• MR systems from Siemens, GE, and Philips across 1.5T and 3T field strengths were used for in-vivo testing (and presumably for phantoms as well).
• The document implies the company is based in the United Kingdom ("OXFORD, OX1 2ET OXFORDSHIRE UNITED KINGDOM"), suggesting the data could originate from there or other international sites. The text doesn't specify if the data was retrospective or prospective, though "acquired from volunteers" might suggest prospective data collection for the precision study if these were specifically for validation.

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

The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set. The data provenance for "Algorithmic Accuracy – Digital Synthetic Data" mentions "the duct file specification of the physically printed phantoms," which suggests an objective, engineered ground truth rather than expert consensus on images for this part of the testing. For in-vivo data, the ground truth establishment method isn't detailed, nor are the experts.

It does state that the device is to be used by a "trained operator, typically a radiographer or technician trained in radiological anatomy" to generate reports for "reporting by a radiologist for subsequent interpretation and diagnosis by a clinician." This describes the user, but not the experts for ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth for the test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No Multi Reader Multi Case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance versus without AI assistance is mentioned in the provided text. The "Intra- and Inter-Operator" section assesses the variability of the device's output when operated by different or the same human operators, not directly the diagnostic performance improvement of human readers using the device.

6. Standalone (Algorithm-Only) Performance Study

Yes, a standalone performance study was conducted. The section "Algorithmic Accuracy – Digital Synthetic Data" describes testing the algorithm's accuracy "against the duct file specification of the physically printed phantoms, a dataset of digital synthetic data." The conclusion clarifies this: "It can be said that the algorithmic accuracy of MRCP+v1 when used to quantify tubular structures from acquired MRCP data is high when not presented with the variability introduced by phantom or in-vivo scanning." This directly speaks to the algorithm's performance independent of scanning variability, which constitutes a standalone assessment.

7. Type of Ground Truth Used

• Algorithmic Accuracy: "Duct file specification of the physically printed phantoms" (an engineered/objective ground truth).
• Device Accuracy (Physical Phantoms): The document implies the "physical phantoms" themselves serve as the ground truth or have known parameters against which the device's measurements are compared.
• Precision (In-vivo Data) and Intra-/Inter-Operator: The ground truth for these measurements (Tree Volume, Gallbladder Volume, Duct Median, etc.) would be the presumed true values derived from the MRCP images, but the method of establishing this ground truth (e.g., expert manual segmentation, another reference standard) is not explicitly described. It measures consistency and agreement between measurements rather than agreement with an external gold standard for these particular sections.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set.

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

The document does not provide any information on how the ground truth for the training set was established.

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