(90 days)
MRCP+ v2 is indicated for use as a software-based image processing system for noninvasive, quantitative assessment of biliary system structures.
MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable the measurement of bile duct widths and quantification of strictures and dilatations. MRCP+ v2 includes tools for interactive segmentation and labelling of the biliary system, including the gallbladder.
MRCP+ v2 provides metrics for interpretation by trained physicians to assist in the assessment of the biliary system. These metrics support physicians in the visualization, evaluation and reporting of hepatobiliary structures.
MRCP+ v2 is designed to utilize DICOM-compliant MRCP datasets acquired on supported MR scanners using supported MRCP acquisition protocols.
MRCP+ v2 is a standalone software medical device. The purpose of the MRCP+ v2 device is to assist a trained operator with the quantitative evaluation of biliary system structures acquired from magnetic resonance (MR) images from a single time-point (a patient visit). A Perspectum-trained operator loads previously acquired magnetic resonance cholangiopancreatography (MRCP) data as input into the MRCP+ v2 device. A structured summary report is generated as output by the device, which includes quantitative analysis results and geometric characteristics of the biliary system and pancreatic ducts. The MRCP+ v2 report is intended to facilitate reporting by a radiologist for subsequent interpretation and to aid diagnosis by a physician as part of a panel of testing, including conventional radiological tools.
MRCP+ v2 is designed to utilize Digital Imaging and Communications in Medicine (DICOM)-compliant MRCP datasets acquired on supported MR scanners to display the fluid-filled tubular structures in the abdomen, including intra- and extra-hepatic biliary tree, gallbladder, and pancreatic duct system. Analysis and evaluation tools in MRCP+ v2 include segmentation of structures utilizing user input of seeding points, interactive labelling of segmented areas, and quantitative measurement derived from segmentation results. MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation in the width of tubular structures, including those quantified as strictures and dilations. MRCP+ v2 includes tools allowing for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.
Here's a breakdown of the acceptance criteria and study information for the Perspectum MRCP+ version 2 (MRCP+ v2) device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally expressed as Bland-Altman 95% Limits of Agreement (LoA) or maximum bias and other precision metrics. The document states that the device successfully met all predetermined acceptance criteria. Therefore, the "Reported Device Performance" effectively matches the "Acceptance criteria" as the device passed.
Table: Acceptance Criteria for MRCP+ v2 Performance
| Metric | Acceptance Criteria (from Tables 2, 3, 4, 5, 6, 7, 8, 9) |
|---|---|
| Individual Duct Metrics (Stricture & Dilatation Phantom) | |
| Duct length (mm) | Max bias: ±9.5, LoA: ±81.3 |
| Stricture length max (mm) | Max bias: ±1.1, LoA: ±14.6 |
| Stricture length mean (mm) | Max bias: ±1.1, LoA: ±14.3 |
| Stricture length sum (mm) | Max bias: ±1.8, LoA: ±17.8 |
| Dilatation length sum (mm) | Max bias: ±2.2, LoA: ±23.2 |
| Dilatation diameter max (mm) | Max bias: ±0.7, LoA: ±6.0 |
| Stricture absolute severity sum (mm) | Max bias: ±2.0, LoA: ±3.8 |
| Dilatation absolute severity sum (mm) | Max bias: ±3.3, LoA: ±5.5 |
| Dilatation absolute severity max (mm) | Max bias: ±1.1, LoA: ±3.8 |
| Stricture relative severity sum (%) | Max bias: ±18.6, LoA: ±76.7 |
| Dilatation relative severity sum (%) | Max bias: ±407.5, LoA: ±520.6 |
| Dilatation relative severity max (%) | Max bias: ±209.6, LoA: ±281.2 |
| Stricture score sum (mm) | Max bias: ±1.95, LoA: ±8.6 |
| Dilatation score sum (mm) | Max bias: ±33.3, LoA: ±49.6 |
| Number of strictures | Max bias: ±1.0, LoA: ±3.0 |
| Number of dilatations | Max bias: ±1.0, LoA: ±3.0 |
| Tube Width Measurements (Tube Width & Clinical Biliary Phantoms) | |
| Accuracy of algorithm - synthetic data: % points stably matched | > 80% |
| Accuracy of algorithm - synthetic data: Absolute value of mean bias | ≤ 0.4 mm |
| Accuracy of algorithm - synthetic data: Largest absolute LoA | ≤ 1.4 mm |
| Accuracy of algorithm - synthetic data: Slope of bias | ≤ 0.1 mm per mm |
| Accuracy of device - acquired data: % points stably matched | > 80% |
| Accuracy of device - acquired data: Absolute value of mean bias | ≤ 0.5 mm |
| Accuracy of device - acquired data: Largest absolute LoA | ≤ 1.5 mm |
| Accuracy of device - acquired data: Slope of bias | ≤ 0.1 mm per mm |
| Repeatability: % points stably matched | > 80% |
| Repeatability: Absolute value of mean bias | ≤ 0.4 mm |
| Repeatability: Largest absolute LoA | ≤ 1.4 mm |
| Repeatability: Slope of bias | ≤ 0.15 mm per mm |
| Reproducibility: % points stably matched | > 80% |
| Reproducibility: Absolute value of mean bias | ≤ 0.6 mm |
| Reproducibility: Largest absolute LoA | ≤ 1.6 mm |
| Reproducibility: Slope of bias | ≤ 0.15 mm per mm |
| Substantial equivalence (v1 vs v2): % points stably matched | > 80% |
| Substantial equivalence (v1 vs v2): Absolute value of mean bias | ≤ 0.6 mm |
| Substantial equivalence (v1 vs v2): Largest absolute LoA | ≤ 1.6 mm |
| Substantial equivalence (v1 vs v2): Slope of bias | ≤ 0.15 mm per mm |
| In Vivo Performance (Summary Whole Tree Metrics - LoA) | |
| Total number of ducts | ±116.2 |
| Total number of strictures | ±16.5 |
| Total number of dilatations | ±33.8 |
| Total number of ducts with a stricture or dilatation | ±27.4 |
| Total number of ducts with a stricture and dilatation | ±9.6 |
| Number of ducts with a stricture | ±12.4 |
| Number of ducts with a dilatation | ±24.5 |
| Duct length mean (mm) | ±12.3 |
| Duct length sum (mm) | ±2082.7 |
| Stricture length sum (mm) | ±121.4 |
| Dilatation length sum (mm) | ±215.8 |
| Abnormal length sum (mm) | ±326.3 |
| Stricture absolute severity sum (mm) | ±32.0 |
| Dilatation absolute severity sum (mm) | ±78.7 |
| Dilatation absolute severity max (mm) | ±4.5 |
| Stricture relative severity sum (%) | ±708.0 |
| Dilatation relative severity sum (%) | ±2437.6 |
| Dilatation relative severity max (%) | ±165.3 |
| Stricture score sum (mm) | ±51.7 |
| Dilatation score sum (mm) | ±179.2 |
| Dilatation diameter max (mm) | ±6.3 |
| Biliary tree volume | ±20 mL |
| Gallbladder volume | ±30 mL |
| Percentage of ducts with median width less than 3 mm | ±40% |
| Percentage of ducts with median width greater than 3 mm up to 5 mm | ±40% |
| Percentage of ducts with median width greater than 5 mm up to 9 mm | ±40% |
| Percentage of ducts with median width greater than 9 mm | ±40% |
| Precision: Repeatability and Reproducibility (Whole Tree Metrics - LoA) | (Same as In Vivo Performance) |
| Precision: Repeatability and Reproducibility (Single Duct Metrics - LoA) | |
| Total number of strictures | ±2.0 |
| Total number of dilatations | ±2.0 |
| Duct length (mm) | ±71.8 |
| Stricture length sum (mm) | ±16.0 |
| Dilatation length sum (mm) | ±21.0 |
| Stricture length mean (mm) | ±13.2 |
| Stricture length max (mm) | ±13.5 |
| Stricture absolute severity sum (mm) | ±1.8 |
| Dilatation absolute severity sum (mm) | ±2.2 |
| Dilatation absolute severity max (mm) | ±2.7 |
| Stricture relative severity sum (%) | ±58.1 |
| Dilatation relative severity sum (%) | ±113.1 |
| Dilatation relative severity max (%) | ±71.6 |
| Stricture score sum (mm) | ±6.6 |
| Dilatation score sum (mm) | ±16.3 |
| Dilatation diameter max (mm) | ±5.3 |
| Median duct width (mm) | ±3 (Repeatability), ±3.5 (Reproducibility) |
| Duct width interquartile range (mm) | ±3.5 (Repeatability), ±4.0 (Reproducibility) |
| Maximum duct width (mm) | ±4.5 (Repeatability), ±4.8 (Reproducibility) |
| Minimum duct width (mm) | ±3.8 (Repeatability), ±3.8 (Reproducibility) |
| Intra and Inter-Operator Assessment (Whole Tree Metrics - LoA) | (Same as In Vivo Performance) |
| Intra and Inter-Operator Assessment (Single Duct Metrics - LoA) | |
| Total number of strictures | ±2.0 |
| Total number of dilatations | ±2.0 |
| Duct length (mm) | ±71.8 |
| Stricture length sum (mm) | ±16.0 |
| Dilatation length sum (mm) | ±21.0 |
| Stricture length mean (mm) | ±13.2 |
| Stricture length max (mm) | ±13.5 |
| Stricture absolute severity sum (mm) | ±1.8 |
| Dilatation absolute severity sum (mm) | ±2.2 |
| Dilatation absolute severity max (mm) | ±2.7 |
| Stricture relative severity sum (%) | ±58.1 |
| Dilatation relative severity sum (%) | ±113.1 |
| Dilatation relative severity max (%) | ±71.6 |
| Stricture score sum (mm) | ±6.6 |
| Dilatation score sum (mm) | ±16.3 |
| Dilatation diameter max (mm) | ±5.3 |
| Median duct width (mm) | ±2.0 |
| Duct width interquartile range (mm) | ±2.0 |
| Maximum duct width (mm) | ±3.0 |
| Minimum duct width (mm) | ±2.5 |
| Equivalence Testing to Predicate Device (LoA) | |
| Median duct width (mm) | ±3 |
| Duct width interquartile range (mm) | ±3.5 |
| Maximum duct width (mm) | ±4.5 |
| Minimum duct width (mm) | ±3.8 |
| Biliary tree volume | ±20 mL |
| Gallbladder volume | ±30 mL |
| Percentage of ducts with median width less than 3 mm | ±40% |
| Percentage of ducts with median width greater than 3 mm up to 5 mm | ±40% |
| Percentage of ducts with median width greater than 5 mm up to 9 mm | ±40% |
| Percentage of ducts with median width greater than 9 mm | ±40% |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions the use of "previously acquired data" for substantial equivalence testing with MRCP+ v1 and "acquired phantom data" for accuracy, repeatability, and reproducibility. Additionally, "volunteer data" was used for clinical precision and operator variability assessments.
-
Phantoms:
- Types: Stricture and Dilatation phantom, Tube Width and Clinical Biliary phantoms, 3D printed phantoms, digital synthetic phantoms.
- Data Provenance: The phantoms were "scanned" on various MRI systems (Siemens 1.5T/3T, GE 1.5T/3T, Philips 1.5T/3T). This indicates controlled, prospective data acquisition specifically for testing. Digital synthetic phantoms are likely "in silico" generated.
- Sample Size: Not explicitly stated as a single number for all phantom tests. The document refers to "the metrics introduced in MRCP+ v2" and comparison of "results from scanned 3D printed phantoms" suggesting multiple phantom uses. For substantial equivalence, it mentions "previously acquired data from Tube Width and Clinical Biliary phantoms."
-
Clinical Data (for Precision, Repeatability & Reproducibility, Intra/Inter-Operator Assessment):
- Types: "Volunteers scanned under the same measurement conditions (twice, on the same scanner, a short time apart for repeatability) and under different measurement conditions (on more than one scanner, compared to a reference scanner for reproducibility)." This confirms prospective data acquisition from healthy individuals or similar.
- Data Provenance: Not explicitly stated (e.g., country of origin), but implies a controlled clinical setting for volunteer scanning.
- Sample Size: Not explicitly stated. The text notes "volunteer data used for the precision experiments was also used to assess inter-operator and intra-operator variability."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
-
Phantom Data:
- Ground Truth: For accuracy assessments, the ground truth was the "specification used to generate the phantom (i.e., the specification file used to create the phantom)" and the "ground truth specification" for digital synthetic phantoms. This implies a known, engineered ground truth rather than expert-derived ground truth.
- Number/Qualifications of Experts: Not applicable, as the ground truth was based on phantom specifications, not expert interpretation.
-
Clinical Data:
- The document implies that "Perspectum-trained operator loads previously acquired MRCP data" and "A structured summary report is generated as output by the device, which includes quantitative analysis results and geometric characteristics of the biliary system and pancreatic ducts." These operators were also involved in inter/intra-operator assessment.
- Ground Truth: The document does not explicitly state how ground truth was established for the clinical precision/variability studies or if a separate, expert-derived ground truth was used for assessing the accuracy of metrics against real anatomy. The focus for clinical testing was on device precision (repeatability and reproducibility) and operator variability, implying a comparison of the device's output against itself under different conditions rather than a comparison to an independent "true" clinical assessment of duct characteristics.
4. Adjudication Method (for the test set)
- Phantoms: Not applicable, as ground truth was derived from phantom specifications.
- Clinical Data (Precision/Operator Variability):
- Adjudication: For inter-operator variability, "two internal operators separately processed the same cases and the metrics obtained by each operator were compared statistically." For intra-operator variability, "one internal operator processed the same set of cases twice... and the metrics from each analysis were compared statistically." The operators were "blinded to all analyses conducted by other operators and origins of datasets." This indicates a statistical comparison rather than a consensus-based adjudication of ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance. The study focuses on the standalone performance characteristics of the MRCP+ v2 device itself, including its accuracy, precision, repeatability, reproducibility, and operator variability, and its substantial equivalence to its predicate device. It assesses the device's ability to generate quantitative measurements, not its impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was conducted, particularly for the "Accuracy of algorithm - synthetic data" (Table 3). This involved comparing the algorithm's output on digital synthetic phantoms directly against the known ground truth specifications of those phantoms. The device is also described as a "standalone software medical device" and the tests for accuracy, repeatability, and reproducibility of the device are essentially standalone assessments of the product's output.
7. The Type of Ground Truth Used
- Phantoms: The ground truth for phantom studies was the specification used to generate the phantom (e.g., the CAD file or design parameters for 3D printed phantoms, or the configuration files for digital synthetic phantoms). This is a precise, known, and engineered ground truth.
- Clinical Data (Precision/Operator Variability): For the clinical precision studies, the ground truth was implicitly the device's own output from repeated measurements or different operators. The goal was to assess consistency of the device, not necessarily its accuracy against an independent clinical ground truth (like pathology or clinical outcomes). The document does not mention ground truth being established by pathology, outcomes data, or expert consensus for the clinical performance evaluation of the metrics themselves.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set of the MRCP+ v2 algorithms. The provided text is a 510(k) summary, which focuses on validation and comparison to a predicate, rather than detailed algorithm development or training data.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. Again, this level of detail is typically not included in a 510(k) summary.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Perspectum Keri Hildick Chief Strategy Officer Gemini One 5220 John Smith Drive Oxford, Oxfordshire OX4 2LL United Kingdom
March 13, 2024
Re: K233930
Trade/Device Name: MRCP+ version 2 (MRCP+ v2) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: December 14, 2023 Received: March 1, 2024
Dear Keri Hildick:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
MRCP+ version 2 (MRCP+ v2)
Indications for Use (Describe)
MRCP+ v2 is indicated for use as a software-based image processing system for noninvasive, quantitative assessment of biliary system structures.
MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable the measurement of bile duct widths and quantification of strictures and dilatations. MRCP+ v2 includes tools for interactive segmentation and labelling of the biliary system, including the gallbladder.
MRCP+ v2 provides metrics for interpretation by trained physicians to assist in the assessment of the biliary system. These metrics support physicians in the visualization, evaluation and reporting of hepatobiliary structures.
MRCP+ v2 is designed to utilize DICOM-compliant MRCP datasets acquired on supported MR scanners using supported MRCP acquisition protocols.
Type of Use (Select one or both, as applicable)
( Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Date Prepared:
12th March 2023
Submitter Details 1
Owner Address:
Perspectum Ltd Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford, OX4 2LL
Owner/Operator Number: Establishment Registration Number: Contact Person:
10056574
3014232555 Bhaskar Chikkanna bhaskar.chikkanna@perspectum.com +44 (0) 1865 655329
2 Subject and Predicate Device
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) number | K233930 | K183133 |
| Legal Manufacturer | Perspectum Ltd. | Perspectum Ltd. |
| Owner/Owner OperatorNumber | 10056574 | 10056574 |
| Device Name | MRCP+ version 2 (MRCP+ v2) | MRCP+ (MRCP+ v1) |
| Proprietary/Common name | MRCP+ | MRCP+ |
| Panel | Radiology | Radiology |
| Regulation | 892.2050 | 892.2050 |
| Risk Class | Class II | Class II |
| Product Class code | LLZ | LLZ |
| Classification | System, Image Processing,Radiological | System, Image Processing,Radiological |
Subject Device Description 3
3.1 General Description
MRCP+ v2 is a standalone software medical device. The purpose of the MRCP+ v2 device is to assist a trained operator with the quantitative evaluation of biliary system structures acquired from magnetic resonance (MR) images from a single time-point (a patient visit). A Perspectum-trained operator loads previously acquired maqnetic resonance cholangiopancreatography (MRCP) data as input into the MRCP+ v2 device. A structured summary report is generated as output by the device, which includes quantitative analysis results and geometric characteristics of the biliary system and pancreatic ducts. The MRCP+ v2 report is intended to facilitate reporting by a radiologist for subsequent interpretation and to aid diagnosis by a physician as part of a panel of testing, including conventional radiological tools.
Image /page/3/Picture/15 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a bold, sans-serif font in blue. To the right of the word is a circular graphic divided into sections of different colors, including blue, green, and pink. Below the word "Perspectum" is the text "K233930".
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Image /page/4/Picture/1 description: The image shows the word "Perspectum" in a bold, dark blue font. To the right of the word is a circular logo. The logo is divided into four sections, with the top three sections colored light blue, green, and pink, respectively, and the bottom section colored dark blue.
MRCP+ v2 is designed to utilize Digital Imaging and Communications in Medicine (D/COM)-compliant MRCP datasets acquired on supported MR scanners to display the fluid-filled tubular structures in the abdomen, including intra- and extra-hepatic biliary tree, qallbladder, and pancreatic duct system. Analysis and evaluation tools in MRCP+ v2 include segmentation of structures utilizing user input of seeding points, interactive labelling of segmented areas, and quantitative measurement derived from segmentation results. MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation in the width of tubular structures, including those quantified as strictures and dilations. MRCP+ v2 includes tools allowing for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.
Image /page/4/Picture/3 description: The image shows a 3D rendering of a network of vessels, likely blood vessels or ducts, with a color gradient indicating the diameter in millimeters. The color scale ranges from red to blue, with red representing smaller diameters (around 0 mm) and blue representing larger diameters (around 12 mm). The vessels are branching out from a central region, with the main trunk appearing in shades of green and yellow, indicating a diameter of approximately 5-8 mm.
Figure 1: 3D image of the biliary tree constructed from MRCP+ and color coded according to duct widths (mm)
The MRCP+ v2 report is intended to supplement conventional radiology reports. MRCP+ v2 does not replace the usual procedures for assessing the biliary system by a reviewing radiologist or interpreting physician, providing many opportunities for competent human intervention images and information. A radiologist or physician must also consider the device's limitations and accuracy when reviewing or interpreting MRCP+ v2 results and reports. Therefore, MRCP+ v2 presents a low level of concern with respect to patient safety since its metrics only augment the clinical information utilized by radiologists and physicians for the medical management of patients.
3.2 Indications for Use
MRCP+ v2 is indicated for use as a software-based image processing system for noninvasive, quantitative assessment of biliary system structures.
MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable the measurement of bile duct widths and quantification of strictures and dilatations. MRCP+ v2 includes tools for interactive segmentation and labelling of the biliary system, including the gallbladder.
MRCP+ v2 provides metrics for interpretation by trained physicians to assist in the assessment of the biliary system. These metrics support physicians in the visualization and reporting of hepatobiliary structures.
MRCP+ v2 is designed to utilize DICOM-compliant MRCP datasets acguired on supported MR scanners using supported MRCP acquisition protocols.
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Image /page/5/Picture/1 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a dark blue, sans-serif font. To the right of the word is a circular graphic that is divided into four sections. The top three sections are colored light blue, green, and pink, while the bottom section is dark blue.
3.3 Intended Patient Population
General population - MRCP+ v2 has no demographic or population restrictions. MRCP+ v2 analyzes hepatobiliary structures from appropriately acquired MR datasets.
MRCP+ v2 is not intended to be used for any specific disease or condition. The information provided by the MRCP+ v2 report may offer valuable additional input to support a diagnostic decision when interpreted by a trained physician.
3.4 Contraindications
MRCP+ v2 is suitable for all patients not contra-indicated for MRI.
MRCP+ v2 has the following contra-indications.
- . MRCP+ v2 reports should not be used as the sole basis for forming a diagnosis – to do so would constitute a misuse of the device.
- . MRCP+ v2 reports should not be used as a control mechanism for biopsy guidance – to do so would constitute a misuse of the device.
- . MRCP+ v2 reports should not be used as a direct control mechanism for the delivery of treatment – to do so would constitute a misuse of the device.
- . MRCP+ v2 reports should not be used as the sole basis for evaluating the response to treatment – to do so would constitute a misuse of the device.
3.5 Intended Conditions
MRCP+ v2 is not intended to be used for the diagnosis, treatment or monitoring of any specific diseases or conditions.
MRCP+ v2 does not have any demographic restrictions.
MRCP+ v2 is indicated for use in any patient where MRI is not contraindicated.
MRCP+ v2 does not require the use of contrasting agent.
3.6 Biological properties
N/A - MRCP+ v2 is a post-processing standalone software device. MRCP+ v2 does not have any chemical, physical or biological properties and does not incorporate substances which are considered medicinal products or human blood derivatives. MRCP+ v2 does not contain tissues, cells, or substances of animal origin.
3.7 Materials
N/A - MRCP+ v2 is a post-processing standalone software device. MRCP+ v2 does not consist of any physical materials. Thus toxicity, flammability, phthalates, contamination because of the inqress or egress of substances are not applicable to this device.
3.8 Substances
N/A - MRCP+ v2 is a post-processing standalone software device. Risks posed by substances or particles, including wear debris, degradation products and processing residues, are not applicable to this device.
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Image /page/6/Picture/1 description: The image shows the word "Perspectum" in a bold, dark blue font. To the right of the word is a circular logo. The logo is divided into four colored sections: light blue, green, pink, and dark blue. The dark blue section is further divided by a white line.
3.9 Lifetime of the device
N/A - MRCP+ v2 is a post-processing standalone software device. The lifetime of the device is indefinite until support for MRCP+ v2 is withdrawn by the manufacturer. The performance characteristics of MRCP+ v2 do not degrade over time. MRCP+ v2 lifetime is dependent on its continued use in accordance with the minimum technical requirements for the operating system, hardware, and browsers.
3.10 Packaging and transport
N/A — MRCP+ v2 is a post-processing standalone software device. The performance characteristics of MRCP+ v2 will not be adversely affected during transport and storage. MRCP+ v2 is operated using general-purpose computing hardware that meets the minimum technical requirements for its use.
3.11 Sterility
N/A - MRCP+ v2 is a post-processing standalone software device. It is non-contact, noninvasive and non-sterile.
3.12 Radiation and energy supply
N/A - MRCP+ v2 is a post-processing software device. It does not emit any kind of radiation. MRCP+ v2 does not supply patients with a source of energy or any other substances.
3.13 Power supply
N/A — MRCP+ v2 is a post-processing software device. The safety of patients does not depend on internal and/or external power supply. MRCP+ v2 does not supply patients with any form of power supply.
3.14 Mechanical properties
N/A — MRCP+ v2 is a post-processing standalone software device. MRCP+ v2 does not emit noise, generate vibrations, or include mechanically moving parts. Compliance with the Machinery Directive (2006/42/EC) is not required.
3.15 Personal protective equipment
N/A - MRCP+ v2 is a post-processing standalone software device. Thus, MRCP+ v2 is not intended to be used as a personal protective equipment. Compliance with the Personal Protective Equipment Directive (2016/425) is not required.
3.16 Electronic instructions for use
The instructions for use accompanying MRCP+ v2 comply with the Electronic Instructions for Use of Medical Devices Regulation (207/2012).
Subject and Predicate Comparison ব
Table 1 provides a comparison of characteristics between the subject device (MRCP+ v2) and the predicate device (MRCP+ v1) to demonstrate substantial equivalence. Differences between the devices are highlighted.
4.1 Subject Device and Predicate Comparison
The following characteristics were compared between the subject device and the predicate device to demonstrate substantial equivalence. Differences between the devices are highlighted.
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Table 1. Comparison between the predicate and subject devices.
| Characteristic | MRCP+ v2 (subject device) | MRCP+ v1 (predicate device) |
|---|---|---|
| Indications forUse | MRCP+ v2 is indicated for use as a software-based image processing system fornoninvasive, quantitative assessment of biliarysystem structures.MRCP+ v2 calculates quantitative three-dimensional biliary system models that enablethe measurement of bile duct widths andquantification of strictures and dilatations.MRCP+ v2 includes tools for interactivesegmentation and labelling of the biliarysystem including the gallbladder.MRCP+ v2 provides metrics for interpretationby trained physicians to assist in theassessment of the biliary system. Thesemetrics support physicians in thevisualization, evaluation and reporting ofhepatobiliary structures.MRCP+ v2 is designed to utilize DICOMcompliant MRCP datasets, acquired onsupported MR scanners using supportedMRCP acquisition protocols. | MRCP+ v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliarysystem structures by facilitating thegeneration, visualisation and review of three-dimensional quantitative biliary systemmodels and anatomical image data.MRCP+ v1 calculates quantitative three-dimensional biliary system models that enablemeasurement of bile duct widths andautomatic detection of regions of variation(ROV) of tubular structures. MRCP+ v1includes tools for interactive segmentationand labelling of the biliary system and tubularstructures. MRCP+v1 allows for regionalvolumetric analysis of segmented tree-like,tubular structures and the gallbladder.Combining image viewing, processing andreporting tools, the metrics provided isdesigned to support physicians in thevisualization, evaluation and reporting ofhepatobiliary structures. These models andthe physical parameters derived from themodels, when interpreted by a trainedphysician, yield information that may assist inbiliary system assessment.MRCP+ v1 is designed to utilize DICOMcompliant MRCP datasets, acquired onsupported MR scanners using supportedMRCP acquisition protocols.MRCP+ v1 is suitable for all patients notcontra-indicated for MRI. |
| IntendedConditions | MRCP+ v2 is not intended to be used for thediagnosis, treatment or monitoring of anyspecific diseases or conditions.MRCP+ v2 does not have any demographicrestrictions.MRCP+ v2 is indicated for use in any patientwhere MRI is not contraindicated.MRCP+ v2 does not require the use ofcontrasting agent. | MRCP+ v1 is not intended to be used for thediagnosis, treatment or monitoring of anyspecific diseases or conditions. |
| Contraindications | Same as predicate | MRCP+ v1 is suitable for all patients not contra-indicated for MRI.MRCP+ v1 has the following contra- indications. MRCP+ v1 reports should not be used as the sole basis for forming a diagnosis - to do so would constitute a misuse of the device. MRCP+ v1 reports should not be used as a control mechanism for biopsy guidance – to do so would constitute a misuse of the device. MRCP+ v1 reports should not be used as a direct control mechanism for delivery of treatment – to do so would constitute a misuse of the device. MRCP+ v1 reports should not be used as the sole basis for evaluating the response to treatment - to do so would constitute a misuse of the device. |
| Device User | Trained Perspectum Operators specifically trained in radiological anatomy. | Trained operator with a background in radiological anatomy, such as an MR radiographer/ MR technician. |
| Report User | Same as predicate | Interpreting physician reporting radiologist |
| Device UseEnvironment | Same as predicate | Installation of MRCP+ v1 is controlled and installed on general purpose workstations at Perspectum's image analysis centre. In the context of use, MRCP+ v1 reports are made available through QAS. |
| Clinical Setting | Same as predicate barring the change to device user. | The MRCP+ v1 device is a standalone software device and prior to use shall be installed on general use workstations at the manufacturer's facilities. The intended users (trained radiographers) will log on to the workstations, access the device, and use the device on general use HD monitors.The intended end users of MRCP+ v1 are clinicians or expert radiologists who receive and interpret MRCP+ v1 report through the QAS portal where DICOM data is uploaded and reports are downloaded. |
| AnatomicalLocation | Same as predicate | MRCP+v1 uses acquired MR images of the mid-abdominal area in humans.MRCP+ v1 is intended to be used in the assessment of the biliary tree and gallbladder structures and has quantification tools for |
| interactive segmentation and labelling ofthese structures. | ||
| EnergyConsiderations | Same as predicate | Software only application. The device, astandalone software application, does notdeliver or depend on energy delivered to orfrom patients. |
| Design: Purpose | Same as predicate | Standalone software application to facilitatethe import and visualization of MR data setsencompassing the abdomen, including theliver with functionality independent of the MRIequipment vendor.Combining image viewing, processing andreporting tools, the metrics provided isdesigned to support physicians in thevisualization, evaluation and reporting ofhepatobiliary structures. |
| Design: Tools | MRCP+ v2 calculates quantitative three-dimensional biliary system models that enablemeasurement of bile duct widths andautomatic detection of regions of variation(ROV) in width of tubular structures.MRCP+ v2 includes tools for interactivesegmentation and identification of the biliarysystem and tubular structures. MRCP+ v2allows for regional volumetric analysis ofsegmented tree-like, tubular structures andthe gallbladder.MRCP+ v2 includes tools for the removal ofGastro-Intestinal (GI) contamination fromincoming MRCP data.MRCP+ v2 also includes tools for improvedoperability, allowing operators to select andname a duct from a dropdown list. Thisreplaces the manual step of typing the duct | MRCP+ v1 calculates quantitative three-dimensional biliary system models that enablemeasurement of bile duct widths andautomatic detection of regions of variation(ROV) of tubular structures.MRCP+ v1 includes tools for interactivesegmentation and identification of the biliarysystem and tubular structures. MRCP+ v1allows for regional volumetric analysis ofsegmented tree-like, tubular structures andthe gallbladder. |
| PerformanceFeatures | name under analysis.Same as predicate | Main software features:• Post-processing, display and allowmanipulation of medical MR images• Image loading and saving• Session file loading and saving• Image viewing• Image manipulation• Image analysis• Image processing |
| Design:Algorithms | Same as predicate | MRCP+ uses algorithms to:• Identify the gallbladder• Identify and enhance tubular structures• Remove shape based small objects |
| Design:GallbladderSegmentation | Same as predicate | Adding and removing branches from theBiliary TreeEstimate tube width and other metrics suchas duct lengthMRCP+ v1 supports semi-automaticsegmentation of the gallbladder form theBiliary tree.Automatic gallbladder identification iscompleted by the MRCP+ v1 device and isreviewed and modified by the operator wherenecessary. Segmentation is completed by the |
| Design:Visualization | Numerous views (2D and 3D) in the MRCP+ v2interface can be used to assist analysis. Theseinclude:• Enhanced MRCP volume• Quantitative biliary tree model with theduct width color map and with thestrictures and dilatations color map• maximum Intensity Projection (MIP) of thebiliary tree• Unfolded duct width graphicOperators can see live views of crosshairplacements during landmarking acrossmultiple image planes simultaneously andadjust contrast where required.Operators will be required to navigate throughthe axial, sagittal and coronal planes using thecrosshair tool to confirm that the 3Dvisualization of the biliary tree is accurate.Operators will be able to remove Gastro-Intestinal (GI) contamination from incomingMRCP data.Operators will be able to select and name aduct from a dropdown list. This replaces themanual step of typing the duct name underanalysis. | MRCP+ v1 device.Numerous views (2D and 3D) in the MRCP+ v1interface can be used to assist analysis. Theseinclude:• Enhanced MRCP volume• Quantitative biliary tree model with theduct width colour map• maximum Intensity Projection (MIP) of thebiliary tree• Unfolded duct width graphicOperators can see live views of crosshairplacements during landmarking acrossmultiple image planes simultaneously andadjust contrast where required.Operators will be required to navigatethrough the axial, sagittal and coronal planesusing the crosshair tool to confirm that the 3Dvisualization of the biliary tree is accurate. |
| Design:SupportedModalities | Same as predicate | DICOM 3.0 compliant MR data. |
| Design: Output | ReportingQuantified metrics and images derived fromthe analysis of the biliary tree are exportedfrom MRCP+ v2 are collated and deliveredinto a report to be evaluated and interpretedby a licensed physician. | ReportingQuantified metrics and images derived fromthe analysis of the biliary tree are exportedfrom MRCP+ v1 are collated and delivered intoa report to be evaluated and interpreted by alicensed physician. |
| Images of the whole biliary tree arerepresented in 4 images within the report:Enhanced MRCP volume Quantitative biliary tree model with the duct width color map with the strictures and dilatations color map A maximum Intensity Projection (MIP) of the biliary tree | Images of the whole biliary tree arerepresented in 3 images within the report:Enhanced MRCP volume Quantitative biliary tree model with the duct width colour map A maximum Intensity Projection (MIP) of the biliary tree | |
| Specific biliary duct models are also shown ina 3D image and regions of interest arepresented as 2D unfolded duct. | Specific biliary duct models are also shown ina 3D image and regions of interest arepresented as 2D unfolded duct. | |
| ValuesBiliary tree volume metrics and metricspertaining to the length and width of thebiliary tree are calculated during analysis andprovided in the report these include thefollowing. | ValuesBiliary tree volume metrics and metricspertaining to the length and width of thebiliary tree are calculated during analysis andprovided in the report these the following. | |
| For full Biliary tree metrics: Biliary tree volume Gallbladder volume Total number of ducts Total number of strictures Total number of dilatations Total number of ducts with a stricture or dilatation Percentage of ducts with median width greater than 3mm up to 5mm For individual identified ducts: Number of strictures Total length of strictures Number of dilatations Total length of dilatations Median width Minimum width Maximum width | For full Biliary tree metrics: Biliary tree volume Gallbladder volume Total number of ducts Percent of ducts with median width less than 3mm Percent of ducts with median width greater than 3mm up to 5mm Percent of ducts with median width greater than 5mm up to 7mm Percent of ducts with median width greater than 7mm For individual identified ducts: Median width Minimum width Maximum width Width inter-quartile range | |
| Regions of interestReporting of statistics on whole trees,individual named ducts with strictures anddilatations, snapshots of parametric maps,and comments entered by a trained operatorrelated to the built model and the selectedduct(s). | Regions of interestReporting of statistics on whole trees andindividual ducts, snapshots of parametricmaps, and comments entered by a trainedoperator related to the initial model and theselected duct(s). | |
| Outputted file formats: PDF JSON | Outputted file formats: PDF | |
| Compatibility withthe environment | Same as predicate | Installation of MRCP+ v1 is controlled and isinstalled on general purpose workstations atPerspectum's image analysis center. |
| Performance | Same as predicate | MRCP+ v1 reads in local files compliant withDICOM 3.0. |
| Validated with digital synthetic phantoms/rawdata, phantom scans, and in-vivo (healthyvolunteer and patients with suspectedhepatobiliary disease) scans. | ||
| Human Factors | Same as predicate | Assessed in accordance with IEC 62366 andFDA guidance document 'Applying HumanFactors and Usability Engineering to MedicalDevices.' |
| Supported MRISystems | Same as predicate | GE, Philips, Siemens 1.5T and 3T, MRI systemsare cleared for use and supported byPerspectum MRCP+ v1 software. |
| Note: On Siemens devices, MRCP+ v1 i1supported on software versions VB andonwards. | ||
| Standards | Same as predicate | IEC 62304, IEC 62366-1, DICOM 3.0, ISO14971, ISO 13485 |
| System/OperatingSystem | Same as predicate | Apple/Mac OS |
| Materials | Not applicable, standalone software | Not applicable, standalone software |
| Biocompatibility | Not applicable, standalone software | Not applicable, standalone software |
| Sterility | Not applicable, standalone software | Not applicable, standalone software |
| Electrical Safety | Not applicable, standalone software | Not applicable, standalone software |
| MechanicalSafety | Not applicable, standalone software | Not applicable, standalone software |
| Chemical Safety | Not applicable, standalone software | Not applicable, standalone software |
| Thermal Safety | Not applicable, standalone software | Not applicable, standalone software |
| Radiation Safety | Not applicable, standalone software | Not applicable, standalone software |
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5 Software Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff: "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." The software level of concern for MRCP+ v2 is Moderate, as per FDA's quidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This device does not control a life supporting or life-sustaining device, nor does it control the delivery of a potentially harmful energy. This device does not control the delivery of treatment, and it does not provide diagnostic information, nor does it provide any vital signs monitoring. The hazard analysis identifies the potential software-related risks of using the device, and the mitigations implemented.
6 Performance Testing
MRCP+ v2 underwent performance testing under controlled conditions to corroborate that it is safe and effective when used as intended. The performance testing conducted demonstrates that MRCP+ v2 is at least as safe and effective as the predicate device.
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Image /page/13/Picture/1 description: The image shows the word "Perspectum" in a bold, sans-serif font. The word is a dark blue color. To the right of the word is a circular logo with four different colored sections: light blue, green, pink, and dark blue. The dark blue section is on the bottom, and the other three colors are on the top.
| Scanners Assessed |
|---|
| Siemens 1.5T |
| Siemens 3T |
| GE 1.5T |
| GE 3T |
| Philips 1.5T |
| Philips 3T |
6.1 Performance Testing - Bench
To evaluate the accuracy, repeatability, and reproducibility of the device, phantoms were used to assess the metrics introduced in MRCP+ v2.
The findings from the performance testing affirm that MRCP+ v2 effectively measures strictures and dilatations using acquired phantom data. The demonstration of substantial equivalence between MRCP+ v2 and the predicate device proves that MRCP+ v2's accuracy carries no additional risks compared to MRCP+ v1. In summary MRCP+ v2 successfully met all the predetermined acceptance criteria outlined in the phantom performance testing.
Accuracy
The accuracy of MRCP+ v2 was determined in two ways: the accuracy of the algorithms and the accuracy of MRCP+ v2 measurements. The accuracy of MRCP+ v2 measurements was determined for each type of scanner (vendor and field strength) by comparing the results from scanned 3D printed phantoms with the ground truth specification used to generate the phantom (i.e., the specification file used to create the phantom). The accuracy of the algorithms was assessed in an idealized situation by comparing a digital synthetic phantom (constructed, in silico, from duct configuration files) with the ground truth specification.
Repeatability and Reproducibility
The repeatability and the reproducibility of MRCP+ v2 device was assessed by scanning the 3D-printed phantom on different MRI scanners at 1.5T and 3T field strengths and comparing the analyzed scans with the reference scanner or between two scans. The repeatability of the MRCP+ v2 device was determined by the difference between two acquisitions under the same measurement conditions (on, off, and then on the scanner). The reproducibility of the device was determined by scanning the 3D-printed phantoms under different measurement conditions and comparing the results with the reference scanner, Siemens 3T Prisma.
Substantial Equivalence
Substantial equivalence is defined as the demonstration that the subject device — MRCP+ v2 — is as safe and effective as the predicate device, MRCP+ v1. Previously acquired data from Tube Width and Clinical Biliary phantoms were analyzed in MRCP+ v2, and the pointwise tube width estimates were compared via Bland-Altman plots.
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Image /page/14/Picture/1 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a bold, sans-serif font in blue. To the right of the word is a circular graphic that is divided into five sections. The top four sections are colored light blue, green, pink, and white, while the bottom section is blue.
Table 2: Acceptance criteria for the additional MRCP+ v2 individual duct metrics, assessed using the Stricture and Dilatation phantom. LoA - limits of agreement
| Metric | Acceptance criteria | |
|---|---|---|
| Maximum bias | Bland-Altman 95% LoA | |
| Duct length (mm) | $\pm$ 9.5 | $\pm$ 81.3 |
| Stricture length max (mm) | $\pm$ 1.1 | $\pm$ 14.6 |
| Stricture length mean (mm) | $\pm$ 1.1 | $\pm$ 14.3 |
| Stricture length sum (mm) | $\pm$ 1.8 | $\pm$ 17.8 |
| Dilatation length sum (mm) | $\pm$ 2.2 | $\pm$ 23.2 |
| Dilatation diameter max (mm) | $\pm$ 0.7 | $\pm$ 6.0 |
| Stricture absolute severity sum (mm) | $\pm$ 2.0 | $\pm$ 3.8 |
| Dilatation absolute severity sum (mm) | $\pm$ 3.3 | $\pm$ 5.5 |
| Dilatation absolute severity max (mm) | $\pm$ 1.1 | $\pm$ 3.8 |
| Stricture relative severity sum (%) | $\pm$ 18.6 | $\pm$ 76.7 |
| Dilatation relative severity sum (%) | $\pm$ 407.5 | $\pm$ 520.6 |
| Dilatation relative severity max (%) | $\pm$ 209.6 | $\pm$ 281.2 |
| Stricture score sum (mm) | $\pm$ 1.95 | $\pm$ 8.6 |
| Dilatation score sum (mm) | $\pm$ 33.3 | $\pm$ 49.6 |
| Number of strictures | $\pm$ 1.0 | $\pm$ 3.0 |
| Number of dilatations | $\pm$ 1.0 | $\pm$ 3.0 |
Table 3: Acceptance criteria for the tube width measurements, which are the same as those that were used for the predicate device MRCP+ v1 (K183133). These are assessed using the Tube Width and Clinical Biliary phantoms LoA limits of agreement
| Acceptance criteria | ||||
|---|---|---|---|---|
| Test | Percentage of pointsstably matched | Absolute valueof mean bias | LargestabsoluteLoA | Slope of bias |
| Accuracy of algorithm - syntheticdata | > 80% | ≤ 0.4 mm | ≤ 1.4 mm | ≤ 0.1 mm per mm |
| Accuracy of device - acquired data | > 80% | ≤ 0.5 mm | ≤ 1.5 mm | ≤ 0.1 mm per mm |
| Repeatability | > 80% | ≤ 0.4 mm | ≤ 1.4 mm | ≤ 0.15 mm per mm |
| Reproducibility | > 80% | ≤ 0.6 mm | ≤ 1.6 mm | ≤ 0.15 mm per mm |
| Substantial equivalence betweenMRCP+ v1 and MRCP+ v2 | > 80% | ≤ 0.6 mm | ≤ 1.6 mm | ≤ 0.15 mm per mm |
Table 4: Acceptance criteria for in vivo performance of summary whole tree metrics. These criteria are presented in phantoms to contextualize the performance in phantoms LoA - limits of agreement
| Metric | Acceptance criteria(Bland-Altmann 95% LoA) |
|---|---|
| Total number of ducts | $\pm$ 116.2 |
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| Total number of strictures | ± 16.5 |
|---|---|
| Total number of dilatations | ± 33.8 |
| Total number of ducts with a stricture of dilatations | ± 27.4 |
| Total number of ducts with a stricture and dilatation | ± 9.6 |
| Number of ducts with a stricture | ± 12.4 |
| Number of ducts with a dilatation | ± 24.5 |
| Duct length mean (mm) | ± 12.3 |
| Duct length sum (mm) | ± 2082.7 |
| Stricture length sum (mm) | ± 121.4 |
| Dilatation length sum (mm) | ± 215.8 |
| Abnormal length sum (mm) | ± 326.3 |
| Stricture absolute severity sum (mm) | ± 32.0 |
| Dilatation absolute severity sum (mm) | ± 78.7 |
| Dilatation absolute severity max (mm) | ± 4.5 |
| Stricture relative severity sum (%) | ± 708.0 |
| Dilatation relative severity sum (%) | ± 2437.6 |
| Dilatation relative severity max (%) | ± 165.3 |
| Stricture score sum (mm) | ± 51.7 |
| Dilatation score sum (mm) | ± 179.2 |
| Dilatation diameter max (mm) | ± 6.3 |
6.2 Performance Testing - Clinical
Precision: Repeatability and Reproducibility
MRCP+ v2's performance testing for precision consisted of assessments of repeatability of the metrics using volunteers scanned under the same measurement conditions (twice, on the same scanner, a short time apart for repeatability) and under different measurement conditions (on more than one scanner, compared to a reference scanner for reproducibility). All tests passed the pre-determined acceptance criteria for repeatability tests across all scanner types. The metrics reported by the internal operators can be considered to have good intra-operator agreement and produce consistent results. In all scanners tested, the metrics reported by the internal operators can be considered to have good agreement and produce consistent results even in the worst-case scenario of different scanners and operators.
| Table 5: Acceptance Criteria for Repeatability of Whole Tree Metrics LoA - limits of agreement | ||||
|---|---|---|---|---|
| -- | -- | ------------------------------------------------------------------------------------------------ | -- | -- |
| Repeatability | Reproducibility | |
|---|---|---|
| Metrics | Acceptance Criteria(Bland Altman 95% LoA) | Acceptance Criteria(Bland Altman 95% LoA) |
| Total number of ducts | ±116.2 | ±116.2 |
| Total number of strictures | ±16.5 | ±16.5 |
| Total number of dilatations | ±33.8 | ±33.8 |
| Total number of ducts with a stricture or dilatation | ±27.4 | ±27.4 |
| Total number of ducts with a stricture and dilatation | ±9.6 | ±9.6 |
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| Number of ducts with a stricture | ±12.4 | ±12.4 |
|---|---|---|
| Number of ducts with a dilatation | ±24.5 | ±24.5 |
| Duct length mean | ±12.3 mm | ±12.3 mm |
| Duct length sum | ±2082.7 mm | ±2082.7 mm |
| Stricture length sum | ±121.4 mm | ±121.4 mm |
| Dilatation length sum | ±215.8 mm | ±215.8 mm |
| Abnormal length sum | ±326.3 mm | ±326.3 mm |
| Stricture length mean | ±8.9 mm | ±8.9 mm |
| Stricture length max | ±19.6 mm | ±19.6 mm |
| Stricture absolute severity sum | ±32.0 mm | ±32.0 mm |
| Dilatation absolute severity sum | ±78.7 mm | ±78.7 mm |
| Dilatation absolute severity max | ±4.5 mm | ±4.5 mm |
| Stricture relative severity sum | ±708.0% | ±708.0% |
| Dilatation relative severity sum | ±2437.6% | ±2437.6% |
| Dilatation relative severity max | ±165.3% | ±165.3% |
| Stricture score sum | ±51.7 mm | ±51.7 mm |
| Dilatation score sum | ±179.2 mm | ±179.2 mm |
| Percentage of ducts with a stricture or dilatation | ±23.2% | ±23.2% |
| Dilatation diameter max | ±6.3 mm | ±6.3 mm |
| Biliary tree volume | ±20 mL | ±20 mL |
| Gallbladder volume | ±30 mL | ±30 mL |
| Percentage of ducts with median width less than 3 mm | ±40% | ±45% |
| Percentage of ducts with median width greater than 3 mm up to 5 mm | ±40% | ±45% |
| Percentage of ducts with median width greater than 5 mm up to 9 mm | ±40% | ±45% |
| Percentage of ducts with median width greater than 9 mm | ±40% | ±45% |
Table 6: Acceptance Criteria for Repeatability and Reproducibility of Single Duct Metrics LoA - limits of agreement
| Repeatability | Reproducibility | |
|---|---|---|
| Metrics | Acceptance Criteria(Bland Altman 95% LoA) | Acceptance Criteria(Bland Altman 95% LoA) |
| Total number of strictures | ±2.0 | ±2.0 |
| Total number of dilatations | ±2.0 | ±2.0 |
| Duct length | ±71.8 mm | ±71.8 mm |
| Stricture length sum | ±16.0 mm | ±16.0 mm |
| Dilatation length sum | ±21.0 mm | ±21.0 mm |
| Stricture length mean | ±13.2 mm | ±13.2 mm |
| Stricture length max | ±13.5 mm | ±13.5 mm |
| Stricture absolute severity sum | ±1.8 mm | ±1.8 mm |
| Dilatation absolute severity sum | ±2.2 mm | ±2.2 mm |
| Dilatation absolute severity max | ±2.7 mm | ±2.7 mm |
| Stricture relative severity sum | ±58.1% | ±58.1% |
| Dilatation relative severity sum | ±113.1% | ±113.1% |
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MRCP+ v2 510k Summary
| Dilatation relative severity max | ±71.6% | ±71.6% |
|---|---|---|
| Stricture score sum | ±6.6 mm | ±6.6 mm |
| Dilatation score sum | ±16.3 mm | ±16.3 mm |
| Dilatation diameter max | ±5.3 mm | ±5.3 mm |
| Median duct width | ±3 mm | ±3.5 mm |
| Duct width interquartile range | ±3.5 mm | ±4.0 mm |
| Maximum duct width | ±4.5 mm | ±4.8 mm |
| Minimum duct width | ±3.8 mm | ±3.8 mm |
Inter and Intra-Operator Assessment
To assess the variability between the metrics obtained by different operators, case-matched comparisons were conducted across all reported metrics. Operators were blinded to all analyses conducted by other operators and origins of datasets. The volunteer data used for the precision experiments was also used to assess inter-operator and intra-operator variability of metrics reported by the MRCP+ v2 device among operators. To assess inter-operator variability, two internal operators separately processed the same cases and the metrics obtained by each operator were compared statistically. To assess intra-operator variability, one internal operator processed the same set of cases twice, with the anonymized cases presented in a randomized order each time, and the metrics from each analysis were compared statistically.
Table 7: Acceptance Criteria for Intra and Inter-Operator Assessment, Whole Tree Metrics LoA - limits of agreement
| Metrics | Acceptance Criteria(Bland Altman 95% LoA) |
|---|---|
| Total number of ducts | ±116.2 |
| Total number of strictures | ±16.5 |
| Total number of dilatations | ±33.8 |
| Total number of ducts with a stricture or dilatation | ±27.4 |
| Total number of ducts with a stricture and dilatation | ±9.6 |
| Number of ducts with a stricture | ±12.4 |
| Number of ducts with a dilatation | ±24.5 |
| Duct length mean | ±12.3 mm |
| Duct length sum | ±2082.7 mm |
| Stricture length sum | ±121.4 mm |
| Dilatation length sum | ±215.8 mm |
| Abnormal length sum | ±326.3 mm |
| Stricture length mean | ±8.9 mm |
| Stricture length max | ±19.6 mm |
| Stricture absolute severity sum | ±32.0 mm |
| Dilatation absolute severity sum | ±78.7 mm |
| Dilatation absolute severity max | ±4.5 mm |
| Stricture relative severity sum | ±708.0% |
| Dilatation relative severity sum | ±2437.6% |
| Dilatation relative severity max | ±165.3 % |
| Stricture score sum | ±51.7 mm |
| Dilatation score sum | ±179.2 mm |
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| Percentage of ducts with a stricture or dilatation | ±23.2% |
|---|---|
| Dilatation diameter max | ±6.3 mm |
| Biliary tree volume | ±20 mm |
| Gallbladder volume | ±30 mm |
| Percentage of ducts with median width less than 3 mm | ±45% |
| Percentage of ducts with median width greater than 3 mm up to 5 mm | ±45% |
| Percentage of ducts with median width greater than 5 mm up to 9 mm | ±45% |
| Percentage of ducts with median width greater than 9 mm | ±45% |
Table 8: Acceptance Criteria for Intra and Inter-Operator Assessment, Single Duct Metrics LoA - limits of agreement
| Metrics | Acceptance Criteria(Bland Altman 95% LoA) |
|---|---|
| Total number of strictures | ±2.0 |
| Total number of dilatations | ±2.0 |
| Duct length | ±71.8 mm |
| Stricture length sum | ±16.0 mm |
| Dilatation length sum | ±21.0 mm |
| Stricture length mean | ±13.2 mm |
| Stricture length max | ±13.5 mm |
| Stricture absolute severity sum | ±1.8 mm |
| Dilatation absolute severity sum | ±2.2 mm |
| Dilatation absolute severity max | ±2.7 mm |
| Stricture relative severity sum | ±58.1% |
| Dilatation relative severity sum | ±113.1% |
| Dilatation relative severity max | ±71.6% |
| Stricture score sum | ±6.6 mm |
| Dilatation score sum | ±16.3 mm |
| Dilatation diameter max | ±5.3 mm |
| Median duct width | ±2.0 mm |
| Duct width interquartile range | ±2.0 mm |
| Maximum duct width | ±3.0 mm |
| Minimum duct width | ±2.5 mm |
Equivalence Testing
Analysis was conducted to compare output measurements of paired subject comparisons between MRCP+ v2 and the predicate device. The operators were blinded to the previous analysis and origins of datasets.
Table 9: Acceptance Criteria for Equivalence Testing of MRCP+ v2 Metrics to the Predicate Device (MRCP+ v1) LoA
- limits of agreement
| Metric | Acceptance criteria(LOA) |
|---|---|
| Median duct width | ±3 mm |
| Duct width interquartile range | ±3.5 mm |
{19}------------------------------------------------
| Maximum duct width | $\pm$ 4.5 mm |
|---|---|
| Minimum duct width | $\pm$ 3.8 mm |
| Biliary tree volume | $\pm$ 20 mL |
| Gallbladder volume | $\pm$ 30 mL |
| Percentage of ducts with median width less than 3 mm | $\pm$ 40% |
| Percentage of ducts with median width greater than 3 mm up to 5 mm | $\pm$ 40% |
| Percentage of ducts with median width greater than 5 mm up to 9 mm | $\pm$ 40% |
| Percentage of ducts with median width greater than 9 mm | $\pm$ 40% |
{20}------------------------------------------------
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6.3 Clinical Investigation
No clinical investigations or studies were conducted during performance testing of MRCP+ v2.
Conclusion 7
The subject device is substantially equivalent to the predicate device, and is based on the following:
- The subject device and predicate device (K183133) are both software-only devices intended to analyze . multi-slice MR data acquired using the specific acquisition protocols, from supported MR systems.
- The labelling for both predicate and subject device are consistent with the intended use, both . predicate and subject devices are limited to their uses in MR image analysis and not to be used inlieu of full patient evaluation or relied upon to make or confirm diagnosis.
- . The subject and predicate devices include software applications which utilize MR data to visualize and enable quantification of hepatobiliary characteristics to provide measurements which may be used to assess biliary health.
In conclusion, MRCP+ v2 is substantially equivalent to the legally marketed predicate device in terms of safety and effectiveness. MRCP+ v2 has been rigorously tested and validated, showing high performance for image processing and analysis.
The data provided in this 510(k) summary, including the results of non-clinical and clinical evaluations, support the claim of substantial equivalence. The software complies with all relevant standards and quidelines, ensuring its reliability and safety for intended users.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).