(129 days)
icobrain ctp is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VM ware, and can be used to perform image processing, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
The input images are CT perfusion images. During the pre-processing, each scan is loaded from the DICOM format: the image data and relevant dicom tags are extracted. The image processing block calculates the perfusion parameters and the volumes of the Tmax abnormality (defined as tissue with delayed arrival) and the CBF abnormality (defined as tissue with delayed arrival and critically decreased cerebral blood flow). Finally, the computed measurements are summarized into an electronic report. Optionally if requested, Tmax and CBF abnormalities segmentations are overlaid on the input images and image volumes of perfusion parameters maps are sent.
Here's an analysis of the acceptance criteria and study details for the icobrain-ctp device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several performance tests. The specific numerical acceptance criteria are not always explicitly stated in the same detail as the results, but the type of metric used and the general outcome can be inferred.
| Test Type | Metric/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy - Clinical Dataset (CBF & Tmax Abnormality Volumes vs. Reference Device) | Percentile 90 of the volume differences for both CBF abnormality and Tmax abnormality. | "All experiments passed the acceptance criteria." (Specific P90 values not provided, but implies they met the set thresholds) |
| Accuracy - Clinical Dataset (Unbiased CBF Abnormality Volume vs. Manual DWI Delineation) | Percentile 90 of the volume differences. | "All experiments passed the acceptance criteria." (Specific P90 values not provided) |
| Accuracy - Clinical Dataset (ROI Volume vs. Manual Annotation) | Percentile 90 of the volume differences. | "All experiments passed the acceptance criteria." (Specific P90 values not provided) |
| Reproducibility - Clinical Dataset (Tmax & CBF Abnormality Volumes on Test/Retest) | Percentile 90 of the volume differences for both CBF abnormality and Tmax abnormality. | "All experiments passed the acceptance criteria." (Specific P90 values not provided) |
| Accuracy - Digital Phantom (Perfusion Parameter Maps: CBV, CBF, MTT) | Correlation, Percentile 90 absolute difference, and mean relative difference between ground truth and estimated values. | "In the digital phantom, the correlation for each perfusion parameter was above 0.90." (Implies P90 absolute difference and mean relative difference also met their criteria, though specific values are not given) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: Not explicitly stated, but mentioned as "a dataset of clinical CTP scans."
- Sample Size for Digital Phantom Test Set: Not explicitly stated, but described as "a wide range of clinically relevant values of perfusion parameters."
- Data Provenance (Clinical Test Set): "The subjects upon whom the software was tested include stroke patients." No specific country of origin is mentioned. It is described as a "clinical dataset," which typically implies retrospective use of existing patient data, but it is not definitively stated as prospective or retrospective.
- Data Provenance (Digital Phantom Test Set): Generated by simulating tracer kinetic theory.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions "manually delineated DWI images" and "manually annotated ROI" for establishing ground truth in the clinical accuracy experiments. However:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified (e.g., specific medical specialty, years of experience).
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. The text refers to "manually delineated DWI images" and "manually annotated ROI," which suggests expert involvement, but whether multiple experts were involved and an adjudication process (like 2+1 or 3+1) was used is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not described in the provided text. The performance evaluations focus on the algorithm's standalone performance against established ground truth (either from reference devices, manual expert delineation, or digital phantoms).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone (algorithm-only) performance evaluations. The device's output (e.g., Tmax and CBF abnormality volumes, perfusion parameter maps) is compared directly to reference data or ground truth without human interaction as part of the primary outcome assessment.
7. The Type of Ground Truth Used
- Clinical Dataset:
- Comparison to a "reference device" for CBF and Tmax abnormality volumes.
- "Manually delineated DWI images" for unbiased CBF abnormality volume.
- "Manually annotated ROI" for ROI volume.
- Digital Phantom Dataset: Ground truth generated by "simulating tracer kinetic theory" for perfusion parameters (CBV, CBF, MTT).
8. The Sample Size for the Training Set
The document does not provide any information about the training set size or methodology. The performance testing section focuses solely on validation data.
9. How the Ground Truth for the Training Set Was Established
As no information is provided about the training set, there is also no information on how its ground truth was established.
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February 28, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Icometrix NV % Dirk Smeets VP Clinical Applications Kolonel Begaultlaan 1b/12 3012 Leuven BELGIUM
Re: K192962
Trade/Device Name: icobrain-ctp Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 24, 2020 Received: January 27, 2020
Dear Dirk Smeets:
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 (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 located 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.
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 803) for
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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192962
Device Name icobrain ctp
Indications for Use (Describe)
icobrain ctp is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VM ware, and can be used to perform image processing, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
| 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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K192962
- 5.1 Submitter
- 5.2 Device
- 5.3 Predicate Device
- 5.4 Device Description
- 5.5 Indications for Use
- 5.6 Comparison with predicate device
- 5.7 Performance testing
5. I Submitter
| Name: | icometrix NV |
|---|---|
| Address: | Kolonel Begaultlaan 1b/123012 LeuvenBelgium |
| Contact Person: | Dirk Smeets |
| Telephone number: | +32 16 369 000 |
| Fax Number: | N.A. |
| E-mail: | dirk.smeets@icometrix.com |
| Date Prepared: | 28 Feb 2020 |
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5.2 Device
| Device Trade Name: | icobrain ctp |
|---|---|
| Common Name | Medical Image Processing Software |
| Classification Name | System, Image processing, Radiological |
| Number | 892.2050 |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
Predicate Device 5.3
| Item | Description |
|---|---|
| 510(k) Number | K180161 |
| Device Name | Viz CTP |
| Original Applicant | Viz.ai, Inc. |
| Regulation Number | 21 CFR 892.2050 |
| Classification Product Code | LLZ |
| 510k Review Panel | Radiology |
5.4 Device Description
The following flowchart illustrates the overall architecture of icobrain ctp.
Image /page/4/Figure/6 description: This image is a flowchart that shows the steps involved in image processing. The first step is to input images in DICOM format. The next steps are preprocessing, image processing, and output generation (report/images). The final step is to generate a final report in PDF or DICOM format and output images in DICOM format.
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The input images are CT perfusion images. During the pre-processing, each scan is loaded from the DICOM format: the image data and relevant dicom tags are extracted. The image processing block calculates the perfusion parameters and the volumes of the Tmax abnormality (defined as tissue with delayed arrival) and the CBF abnormality (defined as tissue with delayed arrival and critically decreased cerebral blood flow). Finally, the computed measurements are summarized into an electronic report. Optionally if requested, Tmax and CBF abnormalities segmentations are overlaid on the input images and image volumes of perfusion parameters maps are sent.
Output of icobrain ctp:
Report:
- volume of brain tissue with elevated time to maximum residual function (Tmax abnormality)
- volume of brain tissue with elevated time to maximum residual function and decreased cerebral blood flow (CBF abnormality)
- mismatch volume (difference between Tmax abnormality and CBF abnormality volumes)
- ratio between Tmax abnormality volume and CBF abnormality volume
- · the time series of the arterial input function, venous output function and the averaged time density curves in the parenchymal tissue
- · the time points/image volumes of the CTP that were excluded because of artefacts (if any)
- temporal mean of the input CT input images with corresponding perfusion parameter maps (time to maximum residual function, cerebral blood flow, cerebral blood volume, mean transit time) at various slices
5.5 Indications for Use
icobrain ctp is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
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5.6 Comparison with predicate device
| Device to market | Proposed predicate device | Proposed Reference device | |
|---|---|---|---|
| DeviceTrade Name | icobrain ctp | Viz CTP | RAPID |
| CommonName | Medical Image Processing Software | Picture archiving and communications system | Picture archiving and communicationssystem |
| 510(k)Number | K192962 | K180161 | K121447 |
| Manufacturer | icometrix NV | Viz.ai, Inc. | iSchemaView, Inc. |
| Kolonel Begaultlaan Ib / 123012 LeuvenBELGIUM | 855 El Camino Real Suite 13A-252Palo Alto, CA 94301 | 323 Olmsted RoadStanford, CA 94305 | |
| RegulationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| DeviceClassificationName | System, Image processing,Radiological | System, Image processing, Radiological | System, Image processing, Radiological |
| ProductCode | LLZ | LLZ | LLZ |
| RegulatoryClass | II | II | II |
| ClassificationPanel | Radiology | Radiology | Radiology |
| Indicationsfor use | icobrain ctp is an image processingsoftware package to be used bytrained professionals, including butnot limited to physicians andmedical technicians. The softwareruns on a standard "off-the-shelf"computer or a virtual platform,such as VMware, and can be usedto perform image processing,analysis, and communication ofcomputed tomography (CT)perfusion scans of the brain. Dataand images are acquired throughDICOM-compliant imaging devices.icobrain ctp provides both analysisand communication capabilities fordynamic imaging datasets that areacquired with CT Perfusion imagingprotocols. Analysis includescalculation of parameters related totissue flow (perfusion) and tissueblood volume. Results of imageprocessing which include CTperfusion parameter mapsgenerated from a raw CTP scan areexported in the standard DICOMformat and may be viewed onexisting radiological imaging viewers. | Viz CTP is an image processing softwarepackage to be used by trained professionals,including but not limited to physicians andmedical technicians. The software runs on astandard "off-the-shelf" computer or a virtualplatform, such as VMware, and can be usedto perform image processing, analysis, andcommunication of computed tomography(CT) perfusion scans of the brain. Data andimages are acquired through DICOM-compliant imaging devices.Viz CTP provides both analysis andcommunication capabilities for dynamicimaging datasets that are acquired with CTPerfusion imaging protocols. Analysisincludes calculation of parameters related totissue flow (perfusion) and tissue bloodvolume. Results of image processing whichinclude CT perfusion parameter mapsgenerated from a raw CTP scan areexported in the standard DICOM formatand may be viewed on existing radiologicalimaging viewers. | iSchemaView's RAPID is an imageprocessing software package to be usedby trained professionals, including but notlimited to physicians and medicaltechnicians. The software runs on astandard "off-the-shelf" computer or avirtual platform, such as VMware, and canbe used to perform image viewing,processing and analysis of brain images.Data and images are acquired throughDICOM compliant imaging devices.iSchemaView's RAPID provides bothviewing and analysis capabilities forfunctional and dynamic imaging datasetsacquired with CT Perfusion and MRIincluding a Diffusion Weighted MRI(DWI) Module and a Dynamic AnalysisModule (dynamic contrast enhancedimaging data for MRI and CT). |
| Basic PACSfunctions | Yes | Yes | Yes |
| Computerplatform | Standard "off-the-shelf" computeror a virtual platform. | Same | Same |
| DICOMcompliance | Yes | Yes | Yes |
| Functionaloverview | icobrain ctp is a software packagethat provides for the quantificationand visualization of the perfusion oftissue based on dynamic contrastenhanced CT images. | Same | Automatic analysis for functional anddynamic imaging datasets acquired withCT Perfusion and MRI including aDiffusion Weighted MRI (DWI) Moduleand a Dynamic Analysis Module (dynamiccontrast enhanced imaging data for MRIand CT). |
| DataAcquisition | Acquires medical image data fromDICOM compliant imaging devicesand modalities. | Same | Same |
| Data/ImageTypes | Computed Tomography (CT) | Same | CT and MR scanner |
| Acquisition and Modalities Features | |||
| CT | CT Perfusion | Yes | Yes |
| Computed Parameter Maps | |||
| Perfusion CT | Cerebral Blood Flow (CBF) | Yes | Yes |
| Cerebral Blood Volume (CBV) | Yes | Yes | |
| Mean Transit Time (MTT) | Yes | Yes | |
| Tissue residue function time topeak (TMax) | Yes | Yes | |
| Measurements/Tools | |||
| Arterial Input Function (AIF) /Venous Output Function (VOF) | Same | Same | |
| Brain mask | Same | Same | |
| Export perfusion files to PACS andDICOM file systems | Same | Same | |
| Acquire, transmit, process, andstore medical images | Same | Same | |
| Volumetry | |||
| DefaultTmaxabnormality | Tmax > 6s | Same | Same |
| Default CBFabnormality | CBF < 30% | Same | Same |
| DefaultMismatchvolume | (Tmax > 6s) - (CBF < 30%) | Same | Same |
| DefaultMismatchratio | (Tmax > 6s) / (CBF < 30%) | Same or not shown | Same |
| Useradjustable | No | Yes | Yes |
| Validation |
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| Description | icobrain ctp was tested: | Viz.ai Inc. performed software verification and validation testing of the device and additional performance testing on commercially available simulated dataset (digital phantom) generated by simulating tracer kinetic theory, and includes a wide range of clinically relevant values of perfusion parameters as ground truth. Correlations between the output of the Viz CTP device and the ground truth values were calculated, and compared to published correlations between the ground truth and the outputs of 7 other commercially available and academic CTP post-processing software. | iSchemaView conducted extensive performance validation testing and a software verification and validation testing of the RAPID system. This demonstrated that the RAPID system provides accurate representation of key parameters diffusion and perfusion processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. Software validation and verification testing demonstrated that the RAPID system met all design requirements and specifications. |
|---|---|---|---|
| on a simulated dataset (digital phantom) generated by simulating tracer kinetic theory, that includes a wide range of clinically relevant values of perfusion parameters (CBV, CBF, MTT) as ground truth. Correlation, p90 absolute difference and mean relative difference between the output of icobrain ctp device and the ground truth values calculated, and compared to preestablished performance goals based on academic literature. on a clinical dataset: the accuracy of the TMax and CBF abnormality volumes the reproducibility of the TMax and CBF abnormalities volumes the accuracy of the soft tissue segmentation | The results of performance testing showed that the Viz CTP device achieved the pre-established performance goals for AIF detection, soft matter extraction, and each perfusion parameter: cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), and time to maximum residue (TMax). | RAPID system met all design requirements and specifications. |
5.7 Performance testing
To demonstrate the performance of icobrain ctp, the measurements are validated for accuracy and reproducibility. Literature review has been performed to set relevant acceptance criteria for each type of experiment.
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The device was tested on a dataset of clinical CTP scans. The subjects upon whom the software was tested include stroke patients. In a first accuracy experiment, the CBF and Tmax abnormality volumes were compared to the corresponding volumes from the reference device. The acceptance criteria were set on the percentile 90 of the volume differences for both the CBF abnormality and the Tmax abnormality. In a second accuracy experiment, the unbiased CBF abnormality volume was compared to ground truth volumes from manually delineated DWI images. The acceptance criteria were set on the percentile 90 of the volume differences. In a third accuracy experiment, the region of interest (ROI) volume was compared to ground truth volumes from manually annotated ROI. The acceptance criteria were set on the percentile 90 of the volume differences. Reproducibility was tested on test and retest CT perfusion images. The retest images were produced by simulating patient motion on the test images. The acceptance criteria were set on the percentile 90 of the volume differences for both the CBF abnormality and the Tmax abnormality.
Additionally, the perfusion parameter maps were tested for accuracy on a digital phantom, generated by simulating tracer kinetic theory, that includes a wide range of clinically relevant values of perfusion parameters (CBV, CBF, MTT) as ground truth. The acceptance criteria were set on the correlation, the percentile 90 absolute difference and the mean relative difference between the ground truth and the estimated values. All experiments passed the acceptance criteria. In the digital phantom, the correlation for each perfusion parameter was above 0.90.
Besides the verification experiments, validation tests demonstrate the system as a whole provides all the capabilities necessary to operate according to its intended use.
5.8 Conclusions
The performance testing presented above establishes that the icobrain ctp is safe and effective for its intended use. The comparison above demonstrates that the icobrain ctp device is substantially equivalent to the predicate device.
| Declarations: | • This summary includes only information that is also covered in the body of the510(k). |
|---|---|
| • This summary does not contain any puffery or unsubstantiated labeling claims. | |
| • This summary does not contain any raw data, i.e., contains only summary data. | |
| • This summary does not contain any trade secret or confidential commercialinformation. | |
| • This summary does not contain any patient identification information. |
This document is reviewed and approved by Dirk Smeets, Vice President Clinical Applications of ico metrix, based on the present data and information.
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Image /page/10/Figure/0 description: The image shows a signature and a date. The signature is in blue ink and is illegible. The date is 28 Feb 2020 and is located to the right of the signature. The image is likely a scan of a document.
§ 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).